Q1 2020 Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the any into Pharmaceuticals first quarter financial results Conference call. At this time, all participants are under listen only mode. After the speakers presentation, there will be a question and answers.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Enanta Pharmaceuticals first Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to Ms. Carol Salini, Director of Investor Relations. Please go ahead, ma'am.
Fashion to ask a question during the session you when needed press star one on your telephone. Please be advised the today's conference is being recorded if you require any further assistance. Please press star Zero I would now like opinion the conference over to Mr. Carol.
[music] Shalini director of Investor.
Please go ahead man.
Carol Macelli: Thank you, Erica, and thanks for joining us this afternoon. The news release with our fiscal first quarter financial results was issued today, and it's available on our website. On the call today are Dr. Jay Luly, President and CEO, Paul Mellett, our Chief Financial Officer, and other members of Enanta's senior management team. Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results A description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC. Enanta does not undertake any obligation to update any forward-looking statements made during this call. I'd now like to turn the call over to Dr. Jay Luly, President and CEO.
Thank you, Eric a and thanks for joining US this afternoon news release with our fiscal first quarter financial results was issued today and is available on our website on the call today's Dr., Jay like President and CEO, Paul Mellett, Our Chief Financial Officer, and other members of an.
Senior management team.
Before we begin with our formal remarks, we want to remind you that we'll be making forward looking statements may include our plans and expectations with respect to our research and development pipeline in financial projections, all of which involves certain assumptions and risk beyond our control that could cause our actual departments and results to differ.
Only from the statements a description of these risks in our most recent form 10-Q and other periodic reports filed with the FCC and enter does not undertake any obligation to update any forward looking statements made during this call I.
I'd now like to turn the call over Dr., Jay like President CEO. Thank you Carol good afternoon, everyone.
Jay R. Luly: Thank you, Carol. Good afternoon, everyone.
On today's call I will discuss our recent clinical development progress on our lead RSP national reach BBU compounds and upcoming milestones to look for in 2020.
Jay R. Luly: On today's call, I will discuss our recent clinical development progress on our lead RSV, NASH, and HPV compounds and upcoming milestones to look for in 2020. I'll begin with ADP 938, the only N-inhibitor, for RSV and clinical development today. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults, and a condition for which there is currently no safe and effective therapy. At the end of 2019, we initiated our Phase 2B study named RSVP, which is a randomized, double-blind, placebo-controlled study of EDP938, designed to enroll approximately 70 subjects up to the age of 75 years, randomized to receive The primary objective of the study is to evaluate the effect of EDP938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of a 14-day study observation period.
I'll begin with ATP nine create the only in inhibitor.
RSP in clinical development today.
Our.
Our speeds of severe respiratory infection associated with significant morbidity and mortality in intense elderly and immune compromised adults and a condition for which there is currently no safe and effective therapy.
At the end of 2019, we initiated our phase Twob study named RSVP, which is a randomized double.
A blind placebo controlled study of GDP nine create.
Designed to enroll approximately 70 subjects up to the age of 75 years randomized to receive either 800 milligrams of GDP nine create or placebo for five days.
The primary objective of the studies to evaluate the effect of.
GDP 938 on the progression of RSV infection, My assessment of clinical symptoms measured over the course of the 14 days study observation period anti viral last because he will be evaluated as a key secondary endpoint.
Jay R. Luly: Antiviral efficacy will be evaluated as a key secondary input. We're pleased to report that we've been able to identify many adult outpatients who had cold-like symptoms that started within 48 hours of their visit to an RSVP study site. Identification of RSV patients in this group has been aided by the prompt onsite confirmation of RSV infection, which we have been providing by PCR test. Unfortunately, it appears that the North American RSV season this winter peaked in December, which is approximately one to two months earlier than in most years. As a result, we have seen fewer RSV cases than expected, and therefore, we are planning to continue the study into the Southern Hemisphere and have enrollment continue at all sites with the goal now to have data in the first half of 2021. In addition to this study, we have also announced plans to initiate a
We're pleased to report that we've been able to identify many adult hofh patients who've had cold.
Like symptoms that started within 48 hours of their visit to an RSVP study site.
Identification of RSP.
There has to be patients.
In this group has been aided by the prompt onsite confirmation of RSV infection, which we have been providing by PCR testing.
Unfortunately.
It appears that the North American ours ski season. This winter peaked in December which is approximately one to two months earlier than in most years. As a result, we have seen fewer RSV cases unexpected and therefore, we are planning to continue the study into the southern hemisphere and have enrollment continue and all sides.
But the goal now to have data in the first half of the 21.
In addition to this study we have also announced plans to initiate additional phase two studies in pediatric patients and transplant patients by the end of this year concurrent with the RSVP study.
Jay R. Luly: Transplant patients by the end of this year concurrent with the RSVP study. We continue to believe that our n-protein inhibitor approach represents the best chance for success against RSV because it attacks the virus's replication machine. Building on our success with viral infections, such as HCV, and our ongoing program with RSV, last month we introduced our newest drug discovery program, which is seeking therapeutics for human metapneumovirus, also known as HMPV. HMPV is a pathogen identified in 2001 that causes upper and lower respiratory tract infections in young children and the elderly, as well as in COPD, asthma, and immunocompromised patients.
We continue to believe that are in protein inhibitor.
Approach represents the best chance for success against RSV, because it attacks the virus is replication machinery.
Building on her success with viral infections, such as huge CV and our ongoing program with RSV last month, we introduced our newest drug discovery program, which is seeking therapeutics for.
<unk> Mehta Pneumo virus also known as H M. P E.
H. MPV is a pathogen identified in 2001 that causes upper and lower respiratory tract infections, and young children and the elderly as well as N C O Pee dee asthma and immunocompromised patients.
Jay R. Luly: During 2020, we will continue to perform optimization of our current nanomolar inhibitor leads against this virus. Now, let's shift to HPV. Our HPV program with EDP 514 is moving ahead nicely. And today, we announced positive results from the SAD and the MAD portions of our phase one study in healthy volunteers. EDP514 is our novel class 2 HPV core inhibitor, sometimes referred to by others as a capsid assembly modulator or a CAM. The aim of Part 1 of this randomized, double-blind, placebo-controlled, first-in-human study of VDP514 was to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses in healthy subjects, while Part 2 will assess the safety and antiviral activity of VDP514 in new suppressed patients with chronic HPV.
During 2020.
We will continue to perform optimization of our current Nanomolar inhibitor leads against this virus.
Now, let's shift to HBV.
Our HBV program with EPA five one fours moving ahead nicely and today, we announced positive results from the S.A.D. and the M.A.D. portion of our phase ones.
Study in healthy volunteers.
The P. five one for its our novel class two HPV core inhibitor, sometimes referred to by others. This accounts at assembly modulator work him.
The most part one of this randomized double blind placebo controlled first in human study of GDP five one.
Sure, what's gonna evaluate the safety Tolerability and pharmacokinetics of single ascending doses and multiple ascending doses in healthy subjects, well part II will assess the safety and any viral activity of 85, one for a new suppressed patients with chronic HBV infection.
Jay R. Luly: Overall, EDP-514 in healthy subjects dosed for up to 14 days was well tolerated with a favorable safety profile. Treatment-emergent adverse events were infrequent and mild in intensity. No one discontinued EDP514 due to adverse events, and there were no significant individual lab data findings or patterns of lab abnormality. Additionally, the pharmacokinetic, or blood level profile, was fully supportive of once-daily doses. Following these promising results, which support further clinical evaluation of EDP514 in HPV patients, Enanta has initiated a study in nuke-suppressed patients. These are patients with chronic HPV infection that is being suppressed with nucleoside reverse transcriptase treatment. We plan to enroll a total of 24 subjects among three escalating dose cohorts with study drug dosed for 28 days. Our goal is to have data from this study in the first quarter of calendar 2021.
Overall GDP five one.
For in healthy subjects dosed for up to 14 days was well tolerated with a favorable safety profile.
Treatment emergent adverse events were infrequent and mild in intensity no one discontinued GDP five one for due to adverse events and there were no significant individual map data findings were.
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Additionally, the pharmacokinetic or blood level profile was fully supportive of once daily dosing.
Following these promising results, which support further clinical evaluation of BDP five one for in HBV patients and Antero has initiated a study and.
Suppressed patients.
These are patients with chronic HBV infection that is being suppressed with nuclear site reverse transcriptase treatment.
We plan to enroll a total of 24 subjects among three escalating dose cohorts with study drug dosed for 28 days. Our goal is to have data from this study.
In the first quarter of calendar 2021.
Jay R. Luly: Next quarter, we plan to initiate a separate study in HPV patients who are not on therapy and who have high levels of virus in their blood, which are also referred to as vireme. Edp514 was selected from our lead series of HPV compounds that are characterized by potent antiviral activity, and promising preclinical data also support our excitement for Edp514 and for this reason, an abstract of the healthy volunteer portion of the study has recently been accepted for presentation at the International Liver Congress, known as EASL. So stay tuned for additional data in April.
Next quarter, we plan to initiate a separate study in HBV patients, who are not on therapy, and who have high levels of virus and their blood. We're also referred to because my remark.
GDP five one for was selected from our lead series of HPV compound.
There are characterized by potent antiviral activity and promising preclinical data also support our excitement for ATP five one for and for this mechanism.
An abstract of the healthy volunteer portion of the study has recently been accepted for presentation at the international liver Congress known as easily.
So stay tuned for additional data in April.
Switching to our Nash program, we're pleased to announce that the Oregon, one phase two a proof of concept study as ATP three or five our lead FXR agonist candidate has been accepted as an oral presentation at EASL.
Jay R. Luly: Switching to our NASH program, we are pleased to announce that the Argon 1 Phase 2a Proof of Concept Study of EDP305, our lead FXR agonist candidate, has been accepted as an oral presentation at EASA. We plan to further evaluate EDP-305 and Argon2, a Phase 2B study in which we expect to initiate dosing by early next quarter. Argon 2 will be a randomized, double-blind, placebo-controlled, 72-week study in approximately 340 subjects with biopsy-proven NASH. The primary endpoint of this study will be improvement of fibrosis without worsening of NASH or NASH resolution without worsening of fibrosis.
We plan to.
Further evaluate GDP three or five in Oregon to assays to be study in which we expect to initiate dosing by early next quarter.
Oregon to will be a randomized double blind placebo controlled 72 week study and approximately 340 subjects with biopsy proven Nash.
The primary endpoint of this study will be improvement at fibrosis without worsening of Nash and or Nash resolution without worsening of fibrosis. We plan to use doses of 1.5 milligram and two milligram with the aim of demonstrating stronger biomarker signals of efficacy and then seen at one.
Milligram and the Oregon, one study and less per riders than seen at the 2.5 milligram in that study.
This study will include a 12 week interim analysis to generate dose information more quickly for potential combinations with other mechanisms and now.
Jay R. Luly: We plan to use doses of 1.5 mg and 2 mg with the aim of demonstrating stronger biomarker signals of efficacy than seen at 1 mg in the Argon 1 study and less pruritus than seen at 2.5 mg in that study. This study will include a 12-week interim analysis to generate dose information more quickly for potential combinations with other mechanisms. Also, in our NASH program, Enanta has identified EDP-297 as its follow-on FXR candidate. Preclinical data on EDP-297 reveal a differentiated profile that delivers high target tissue distribution, along with potency greater than that published on any FXR agonist in clinical development today. Last month at the J.P. Morgan Conference, we presented compelling data that demonstrate the high-potency and tissue-targeting characteristics of EDP297 compared to other FXR agonists in development.
Also in our Nash program and antennas identified.
80 to 97 as its follow on FX our candidate.
Preclinical data on AG 297 reveal a differentiated profile that delivers high target tissue distribution, along with potency greater than that published on any FXR agonist and clinical development today.
Last month at the JP Morgan Conference, we presented compelling data that demonstrate the high potency and tissue targeting characteristics of ATP to nine seven compared to other FX our agonists in development.
As tissue targeting data show that in preclinical models GDP to nine seven deliberate the drug preferentially.
Lead to tissues involved in FX, our activity, namely liver in an intestine, while minimizing drug levels and plasma and skin.
Two abstracts on ATP to nine seven had been accepted and will be presented at the easel conference in April.
We believe that having a highly potent and highly targeted.
FXR agonist like 80 to 97, we allow for lower doses and reduced to drug levels at non targeted tissues, thereby potentially reducing providers and must provide us is FX, our mediated by FX arbor sectors in the liver or in testing.
Jay R. Luly: This tissue targeting data shows that in preclinical models, ADP297 delivered the drug preferentially to tissues involved in FXR activity, namely liver and intestine, while minimizing drug levels in plasma and skin. Two abstracts on ADP297 have been accepted and will be presented at the EASL conference in April. We believe that having a highly potent and highly targeted FXR agonist like EDP-297 may allow for lower doses and reduced drug levels in non-targeted tissue, thereby potentially reducing pruritus, unless pruritus is mediated by FXR receptors in the liver or intestine.
We plan to.
To initiate a phase one study of GDP to nine seven and mid calendar 2020 and to have data in the first half of 2021.
Lastly, the Intrepid study of MDP, three or five in PBC is completed dosing and we expect to announce topline data by early next quarter.
So keep your eye on.
For presentation of phase one results of PDP five one for diesel.
Initiation of our phase one study of GDP five one for Inphi remake HBV patients.
Phase two results of ATP, three or five in PBC and initiation of our phase one study of ATP to nine seven.
All by mid year.
I'd like to close by summarizing a couple of key takeaways from today first that despite the vagaries of the RSV season in North America. We are advancing the RSVP study and have plans for two additional studies of PDP nine create the started and other RSV patient populations later.
Jay R. Luly: We plan to initiate a Phase I study of EDP297 in mid-calendar 2020 and to have data in the first half of 2021. Lastly, the intrepid study of ADP-305 and PBC has completed dosing, and we expect to announce top-line data by early next quarter. So keep your eye out for the presentation of phase one results of EDP514 at easel and the initiation of our phase 1B study of EDP514 in viremic HPV patients. I'd like to close by summarizing a couple of key takeaways from today. First, that despite the vagaries of the RSV season in North America, we are advancing the RSVP study and have plans for two additional studies of EDP938 to start in other RSV patient populations later this year. And second, we had good safety and PK results with our lead HPV core inhibitor and healthy volunteers, leading us to initiate the second part of the study in nuke-suppressed HPV.
This year.
And second we had good safety and PK results with our lead HPV core inhibitor in healthy volunteers, leading us to initiate the second part of this study and nuke suppressed HBV patients. This is all good progress.
Well now turn the call over to Paul to discuss our financials for the quarter Paul Thank.
Jay I'd like to remind everyone that an answer reports on the September thirtyth fiscal year schedule. Today, we are reporting results for our first quarter ended December 31, 2019th.
The quarter total revenue was 52.6 million and consisted entirely of royalty revenue earned on Abbvies global.
CV product sales.
Compared to total revenue was 69.9 million for the same period in 2018.
Royalty revenue was calculated on 50% of Maverick sales at a royalty rate for the quarter, a 17% and on approximately 30% of the care sales at a royalty rate of 10%.
After adjustment for certain contractual discounts and rebates, which historically has been approximately 1.5% of Abbvies total reported HCV product sales.
I think we'll be reporting that global HCV POLT HCV sales number on February 7th.
As a reminder, royalties I calculated on a calendar.
Your basis, therefore royalties for our fiscal first quarter ending December 31 will be calculated the highest royalty rate and royalties for our fiscal quarter ended March 31st will be calculated at 10%, our lowest royalty rate tiers and our fiscal year.
Paul J. Mellett: This is all good progress. We'll now turn the call over to Paul to discuss our financials for the quarter. Paul. Thank you, Jay.
Paul J. Mellett: Thank you, Jay. I'd like to remind everyone that Enanta reports on a September 30th fiscal year schedule. Today we are reporting results for our first quarter ended December 31, 2019. The quarter's total revenue was $52.6 million and consisted entirely of royalty revenue earned on AbbVie's global HCV product sale. This compares to total revenue of $69.9 million for the same period in 2018. Royalty revenue is calculated on 50% of Maverick sales at a royalty rate for the quarter of 17%, and on approximately 30% of Viqueira sales at a royalty rate of 10% after adjustment for certain contractual discounts and rebates, which historically have been approximately 1.5% of AVI's total reported HCV product sales. AbbVie will be reporting its global HTV sales numbers on February 7.
You can review our royalty tier schedule in our 2019 form 10.
Hey.
Moving onto expenses for the three months ended December 31, 2019 research and development expenses totaled 32.8 million compared to 34.9 million for the same period in 2018.
The decrease was primarily due to the timing of clinical trial costs associated with the progression of our.
Wholly on clinical programs, and RSC Nash PBC and HPV.
General and administrative expense for the quarter was 6.9 million a slight decrease to the comparable quarter in 2018.
And into recorded an income tax expense of 1.5 million for the three months ended December 30 120.
90, compared to income tax expense of 3.7 million for the same period in 2018, reflecting the reduction in income tax and income before income taxes.
For the three months ended December 31, 2019, Enantas effective tax rate was approximately 10% compared to approximately 12.5% for the corresponding period.
In 2018.
Reduction in rate was driven by both research and development credits as well as a federal benefit from foreign derive royalty income.
Operator: As a reminder, our royalties are calculated on a calendar year basis. Therefore, royalties for our fiscal first quarter ending December 31 will be calculated at the highest royalty rate, and royalties for our fiscal quarter ending March 31 will be calculated at 10%, our lowest royalty rate tier in our fiscal year. You can review our royalty tier schedule in our 2019 Form 10-K. Moving on to expenses, for the three months ended December 31, 2019, research and development expenses totaled $32.8 million, compared to $34.9 million for the same period in 2018. The decrease was primarily due to the timing of clinical trial costs associated with the progression of our wholly-owned clinical programs in RSV, NASH, PBC, and HBV. General and Administrative Expense for the quarter was $6.9 million, a slight decrease from the comparable quarter in 2018, and Enter recorded an income tax expense of $1.5 million for the three months ended December 31, 2019 compared to $3.7 million for the same period in 2018, reflecting the reduction in income tax in income before income tax.
Net income for the three months ended December 31, 2019 was 13.4 million or 65 cents per diluted common share compared to a net income of 26 million.
Our dollar 25 per diluted common share the corresponding period in 2018.
And then to ended the quarter with approximately 415 million in cash and marketable securities an increase of approximately 15 million for my 2019 fiscal yearend balance of 400 million.
Further financial details are available in our press release.
Police and will be available in our quarterly report on form 10-Q, one filed.
I'd now like to turn the call back to the operator and open up the lines for questions operator.
As a reminder to asking question you we need to press star one on your telephone can withdraw your question press the pound key any interest of time, we do ask that you limit.
12 to one question and one follow up so that everyone has a chance to ask your question. Please standby all the capacity thereafter.
Your first question is from Brian Abrahams Butt RBC.
Hey, guys. Thanks, so much for taking my questions.
First off on 938.
On the RSV program.
I know you mentioned that you'll be getting the transplant and pediatric studies.
Underway later this year I was wondering if you could talk a little bit more about how you guys are thinking about the potential design there and in particular.
How about what's going to be shaping elements like the dose.
Operator: For the three months ended December 31, 2019, Enanta's effective tax rate was approximately 10%, compared to approximately 12.5% for the corresponding period in 2018. The reduction in rate was driven by both research and development credits, as well as a federal benefit from foreign-derived royalty income. Net income for the three months ended December 31, 2019 was $13.4 million, or $0.65 per diluted common share, compared to a net income of $26 million, or $1.25 per diluted common share, for the corresponding period in 2018. Enanta ended the quarter with approximately $415 million in cash and marketable securities, an increase of approximately $15 million from our 2019 fiscal year-end balance of $400 million. Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed. I'd now like to turn the call back to the operator and open up the lines for questions. Operator?
Low dose selection of potential duration.
Good luck to get those studies going later that had a follow up.
Yes.
Thanks for the question Brian.
The team is working.
Right now on the fine details of both those studies so.
I'd say, it's a little bit premature on this call too.
To get into that I'd say.
As the year progresses, we will report more on RSVP and as the.
The exact design of these two new studies gels.
We'll have.
We'll have a lot more to say about it.
Okay Fair enough and then it sounds like the.
Be program.
Moving along well with five one for.
Was wondering if you could maybe just elaborate a little bit more on on what you guys observed in the in healthy volunteer Phase one study with respect to PK and safety.
Your thoughts on the therapeutic window for that agent and anything at least that you're able to glean from the phase one study that.
Might support your view of this being differentiated from others in the same class and development. Thanks.
Well certainly.
To start with a little bit of the preclinical background on.
Brian Corey Abrahams: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. In the interest of time, we do ask that you limit yourself to one question and one follow-up so that everyone has a chance to ask their question. Please stand by while we compile the Q&A roster. Your first question is from Brian Abrahams with RBC. Hey guys,
By one or two first.
So five one for.
Worked on time to identify this.
Candidates and.
Picked up we believe it's has.
A great preclinical profile not only in terms of by raunchy both.
True it and in vivo, where it certainly looks better than first generation.
Jay R. Luly: Thanks so much for taking my questions. First off, on 938, the RSV program, I know you mentioned that you'll be getting the transplant and pediatric studies underway later this year. I was wondering if you could talk a little bit more about how you guys are thinking about the potential design there, and in particular, what's going to be shaping elements like the selection, and potential duration, as you look to get those studies going later.
Capsid or a core capsid inhibitors.
You know everything about that preclinical profile, including the pharmacokinetic profile across multiple different species suggested that it had a pretty good chance of heavy I know you.
A strong profile clinically too so.
Yeah, we'll have a.
A lot of details around the status at presented formally at.
That easily but suffice to say.
It was generally safe well tolerated.
Again nothing.
Jay R. Luly: Yeah, so thanks for the question, Brian. You know, the team is working right now on the fine details of both of those studies. So I'd say it's a little bit premature on this call to get into that. I would say, as the year progresses, we'll report more on RSVP, and as the exact design of these two new studies gels, we'll have a lot more to say about it then.
Remarkable in terms of any findings and.
Importantly in and as you know the the PK.
Is really all important when you're looking at and viral some so we think we've cut.
Good exposures.
Good troughs and so forth that would give us.
A good amount or pressure.
On the virus. So this is say.
Jay R. Luly: Okay, fair enough. And then, it sounds like the HEPI program is moving along well with 5.1.4. I was wondering if you could maybe just elaborate a little bit more on what you guys observed in the Healthy Volunteer Phase 1 study with respect to PK and safety, your thoughts on the therapeutic window for that agent, and anything at least that you're able to glean from the Phase 1 study that might support your view of this being differentiated from others in the same class and development. Thanks.
Hey, 14 days study and.
It's on healthy, we'll we'll we'll lay it out very clearly with all the detailed said that he is on.
The results are definitely stronger.
Great. Thanks, very much Jay.
You're welcome.
Your next question is from Eric Joseph with JP Morgan.
Hi.
Thanks for taking the questions I'm a couple from me first on.
Five one for.
I guess I'm thinking about.
The phase one B study portion in new suppressed patients.
If I heard correctly that would be a mad study.
Jay R. Luly: Well, certainly, I'll just start with a little bit of the preclinical background on 5142 first. So 514, you know, we worked a long time to identify this.
But that's thing.
Hi, one for 20 day treatment period can you talk little about sort of the study objective.
In that.
Trial portion how are you looking at.
Antiviral activity can you walk us through sort of the surrogates for so I think if you're looking at your conversion or PG Arnie.
Jay R. Luly: Unknown Speaker 0, PICTA, we believe it has, you know, a great preclinical profile, not only in terms of virology, both in vitro and in vivo, where it certainly looks better than first generation capsid or core capsid inhibitors. You know, everything about that preclinical profile, including the pharmacokinetic profile across multiple different species, suggested that it had a pretty good chance of having a strong profile So, you know, we'll have a lot of details around this data set presented formally at an easel, but suffice it to say. It was generally safe and well tolerated. Again, nothing remarkable in terms of any findings. Importantly, and as you know, the PK is really important when you're looking at virals. And so we think we've got, you know, good exposures and good troughs and so forth that would give us a good amount of pressure on the virus. So this is a 14-day study, and it's in HealthEase, but we'll lay it out very clearly with all the details at easel. But the results are definitely strong.
Yeah again, I'll remind you that this is a phase one be 28 day.
Study so it's.
It's a short term.
I'd, where we'll be looking.
Principally at a at safety is a primary endpoint, but I'll, let notably comment on some of the other aspects related to.
Other other things will be study yeah, hi, Thank you for your question facing just to Echo what Jade.
The second part.
First human study so the one be we'd be looking covidien, you simply subject save Cpk, all the key primary and secondary objectives.
We will be also looking at exploratory endpoint.
That's you know on the old deals a company I would say you know in that.
In that you are looking just to remind you that so for all of those.
Point easing patient on you could place Steve.
Exploratory in essence, so we'd be looking at you know some things such as HBV DNA.
HBV DNA and or is there and we we pulled that.
Eric William Joseph: Great. Thanks very much, Jay. You're welcome. Your next question is from Eric Joseph with J.P. Morgan.
We are finalizing the study.
Great and maybe just a separate question on the RSVP study.
Eric William Joseph: Hi, thanks for taking the questions. A couple for me first on 514. I guess I'm thinking about the Phase 1B study portion in nuke-suppressed patients. If I heard correctly, this would be a MAD study assessing 514 patients over a 28-day treatment period. Can you talk a little bit about sort of the study objectives in that trial portion? What are you looking at... Antiviral Activity? Can you walk us through sort of the surrogates for efficacy you're looking at for our conversion or PGRNA?
Just wanted to revisit the trial design and powering assumptions there.
Can you kind of just talk about what the power. What's the trial is powered to detect in terms of total symptom reduction versus no treatment and I'm also curious to know whether I'm looking at some of the blue antiviral programs are useful comps.
In terms of thinking about longer term study design and weather.
That's appropriate looking at prime defense, and whether or not you're looking at trying to implement away from thanks.
So I think I I was very clearly you first question about the polar Oh, the U.P. study I'm not sure I completely understood. The second thought that maybe you can read between say it was different spot.
Jay R. Luly: Yeah, again, I'll remind you that this is a phase 1b 28 day study. So it's a short term study where we'll be looking principally at safety as the primary endpoint, but I'll let Natalie comment on some of the other aspects related to other things to be studied.
I think we ask that question on a few times.
Joining the call obviously be steady.
We have as you know run a challenge steady and there was a what's the used as far as understanding.
Unknown Speaker: Yeah, hi. Thank you for your question. So I think just to echo what Jay said, this is the second part of a first in-man study. So the 1B will be looking, obviously, at nuke-suppressed subjects, safety, PKR, the key primary and secondary objectives. We will also be looking at exploratory endpoints that, you know, all the other companies, I would say, in that field, are looking at. Just to remind you that, so far, all those endpoints in viremic patients or nuke-suppressed patients are still considered exploratory in essence. So we will be looking at, you know, something such as HBV DNA, HBV RNA, and others. And we will report that as we are, obviously, finalizing the study.
Oh drilling in context of the patients who received depression.
Into China study to really you don't see for you and I realize.
Tony.
The dynamic with symptoms.
I was evolving over time.
Im not.
Yes, we need to disclose complete we powered this study as I think it's more Williams.
When you presented data, but oh, he we'd be looking at seeing a difference of the progression of the symptoms of from time to unsaid over 14 days close of steady clinic.
I know, it's in direct way of responding that that's what's going to him.
Today would you would you remind me the second part a few questions.
Sure.
Eric William Joseph: Great. And maybe just a separate question on the RSVP study. I just wanted to revisit the trial design and powering assumptions there. Can you kind of just talk about what the trial is powered to detect in terms of total symptom reduction versus no treatment? And I'm also curious to know whether looking at some of the flu antiviral programs is useful in terms of thinking about longer-term study design and whether, if that's appropriate, looking at time-to-symptom resolution.
I'm curious to know whether you're looking at times and symptom resolution.
Specifically and the RSVP study and the reason for asking the question to that that is an endpoint.
You just Andy.
Influenza anti viral studies, but I'm wondering whether that is a useful.
Compared or set of studies to look at been thinking about longer term development a bit.
Pivotal development essentially of the PDP.
938 thanks.
Yes. Thank you I. Appreciate you question. So obviously, we have looked at many of the flu study to understand.
Unknown Speaker: Thanks.
Unknown Speaker: So I think I heard your first question very clearly about the power of the RSVP study. I'm not sure I completely understood the second part, but maybe you can repeat it once I address the first.
And and sometimes in relationship to debt patient population, there's a series of key secondary endpoint as we'd be looking at more details time too.
Unknown Speaker: So I think we had that question a few times, Luke, regarding the power of the RSVP study. We have, as you know, run a challenge study. And that was what we used as far as understanding our drug in the context of the patient who received the placebo in the challenge study to really identify and analyze. Clearly, the dynamic at Centrums was evolving over time. I'm not, Yet we need to disclose completely how we powered the study, as I think it's more relevant when you present the data, but obviously, we will be looking at seeing a difference in the progression of the symptoms from time to onset over a 14-day course of study conduct. I know it's an indirect way of responding, but that's what I can offer today. Would you remind me the second part of your question, please?
Resolution time to fluctuation.
They we'd give you more details analyzes the symptoms.
Great. Thanks for taking the question.
You're welcome.
Your next question is from Yasmeen Rahimi with Roth capital.
[noise].
Hi, Paul on for you guys need thanks for taking my question.
The first I just wanted to ask about again about RSVP can you talk more about the confirmation of RSV diagnosis in the optimal window for the study.
PCR be used to determine quantitatively efficient viral loads hauled the optimal range for intervention.
So we are using what it does need to PCL one to patient a show up the clinic, we seem to 48 hours of the window. So it's come from.
Right and they will either be centralized also PCR that you do.
Eric William Joseph: I'm curious to know whether you're looking at time-to-symptom resolution, specifically in the RSVP study, and the reason for asking the question is that that is an endpoint used in the influenza antiviral studies, and I'm wondering whether that is a useful... comparator set of studies to look at when thinking about longer-term development of the pivotal development potentially of EDP 938. Thanks.
<unk>.
Okay, Okay, and just one more question can you give some more color and what the profile.
Drew scenic patient would look like in the next portion of the platform for study.
Say that one more time please.
I was wondering what the profile green patient in the next.
Portion of the GDP five one for study with looked like.
The profile it differently.
In slide one form for the BV.
Unknown Speaker: Yes, thank you. I appreciate your question.
Okay. So we I didn't [laughter] you switched to the age baby. So there will be patient well by many companies you rather high on.
Unknown Speaker: So, obviously, we have looked at many other flu studies to understand endpoints and symptoms in relationship to, you know, that patient population. There's a series of key secondary endpoints that we'll be looking at in more detail, time to resolution, time to progression. There will be, obviously, more detailed analysis of all the symptoms.
It would be BDNA them when they could be done naive of treatment on degree now receive treatment that.
I think you know and wishing.
Window, where they don't receive any treatment the data to show and indeed.
Maybe DNA entry.
Gotcha.
Unknown Speaker: Great, thanks for taking the questions.
Okay. Thanks, so much.
Unknown Speaker: You're welcome.
Good.
Your next question is from a comp.
Yasmeen Rahimi: Your next question is from Yasmeen Rahimi with Roth Capital. Hi team, Paul answering for Yasmeen. Thanks for taking my call. So first, I just wanted to ask more about confirmation of RSV diagnosis in the optimal window for the study and can PCR be used to determine quantitatively if patients' viral loads fall in the optimal range for intervention?
Wolfe research.
Hey, guys, Oh, so maybe on the RSV trial, a maybe a little bit of color on why you chose eight you see symptom benefit as your fees to be primary.
Point versus maybe like baseline viral load or something that use in phase, one well or some of the flu trials.
Unknown Speaker: So we are using rapid tests, and it's a PCR. When the patient shows up at the clinic within the 48 hours of the window, it's confirmed at the site. And there will also be a centralized PCR that we do afterward.
Would love to get some detail on that Additionally, a in your protocol you say that patients left to present within 48 hours a symptom onset are there any tricks that you're using for the trial to kind of ensuring that patients.
Since our actually presenting within that that treatment of video I mean that treatment timeline and finally it seems like you you're I I think you had previously mentioned that the powering was going to be similar to phase. One. So I think that was around 80% powered is there a chance that you could increase your enrollment now that the trials getting pushed too.
Unknown Speaker: Okay. Okay, and just one more question. Could you give some more color on what the profile of a verisimic patient would look like in the next portion of the EDP-514 study?
Unknown Speaker: Say that one more time, please.
Unknown Speaker: I was wondering what the profile for varemic patients in the next portion of the EDP 514 study would look like.
Unknown Speaker: The Profile of the... The Profile of the...
The first half 21, thanks, so much.
Unknown Speaker: Okay, sorry, I didn't, you switched to HBV, so there will be patients who are viremic, obviously who have a higher level of HBV DNA than the nukes suppressed; they could be either naive to treatment or they could have received treatment but had a, you know, washing a window where they don't receive any treatment, but they have to show an elevated level of HBV DNA at entry.
So there is I don't think there any special tricks.
We're taking people as they present and and we have to rely on the reliability of what they say in term sometimes obviously there are the only people who can no.
But the good news is we're seeing lots of people coming in within that time window with.
With sometimes.
The.
Okay.
Could you repeat your first question. The first part of your first question again, yeah, absolutely. So I think.
Unknown Speaker: Okay, thanks so much. Your next question is from Akash Tiwari with Wolf Research. Hey guys,
Akash Tiwari: So maybe on the RSV trial, maybe a little bit of color on why you chose AUC symptom benefit as your Phase 2b primary endpoint versus maybe like baseline viral load or something they use in Phase 1 or some of the flu trials. I would love to get some detail on that. Additionally, in your protocol, you say that patients will have to present within 48 hours of symptom onset. Are there any tricks that you're using for the trial to kind of ensure that patients are actually presenting within that treatment timeline? And finally, it seems like you're, I think you had previously mentioned that the powering was going to be similar to Phase 1, so I think that was around 80% powered. Is there a chance that you could increase your enrollment now that the trial is getting pushed to first half of 21? Thanks so much.
We're looking at like JNJ outpatient RSV phase II their pilot trial and they're looking at a lot of primary and secondary endpoint file kinetic ratio symptoms. So why specifically, it's an interesting endpoint and you see symptom benefit as your primary endpoint does it somehow give you a bit more wiggle room that than some of these other.
Sorry endpoints that other companies are looking at.
I think the choice of he as far as the primary endpoint to look into the total symptoms cool was.
Mainly driven so to the understanding and the very.
Another he's AFFO challenged.
As we walk we dose that decision.
The Oh that you see.
Jay R. Luly: So there, I don't think there are any special tricks. I think we're taking people as they present, and we have to rely on the reliability of what they say in terms of symptoms. Obviously, they're the only people who can know. But you know, the good news is we're seeing lots of people coming in within that time window with The
School will be a better and point what are looking for in the context of that study.
Got it.
It's also easier on an outpatient basis to give it to.
To get more data points because.
People will be reported sometimes.
Jay R. Luly: Could you repeat your first question, the first part of your first question, again?
Been diaries et cetera. So.
Just as a from a practical basis on an outpatient study.
Akash Tiwari: Yeah, absolutely. So I think we were looking at J&J's outpatient RSV phase 2, their pilot trial, and they're looking at a lot of primary and secondary endpoints, viral kinetics, radiation symptoms. So why specifically is it an interesting endpoint, AUC symptom benefit as your primary endpoint? Does it somehow give you a bit more wiggle room than some of these other exploratory endpoints that other companies are looking
You can you can get more data.
Sampling that way.
Just want to complement to what you say the bed to tweak I mean, there's obviously [laughter].
There's obviously a lot the for that one into.
Educating decide and decide educating.
Patients that come to see them, we are using semi party.
Emergency care.
Center, we have patient, we I know G us most U.P.D. So we have launch a large campaign.
Unknown Speaker: I think the choice of the AUC as far as the primary endpoint to look into the total symptom score was mainly driven by our understanding and the very thorough analysis of our challenge data. As we worked with our statistician, we thought that AUC for symptom score would be a better endpoint for what we are looking for in the context of that study.
That I tried to attract patient we clear understanding of the eligibility criteria as follows study so we weigh both.
To be successful in that sense to that truck station, we symptom we didn't know window.
Got it and just I just a quick question given the trial delay on the RSV side.
Is there any chance that you'd be looking at increasing the enrollment. So suddenly you might have more of a flu like I told number.
Jay R. Luly: to get more data points because people will be reporting symptoms, and Diaries, etc. So it's just as from a practical basis as an outpatient study. You can get more data sampling that way.
Patience in your trial versus something more in line with other RSV phase to be studies.
Unknown Speaker: Just want to compliment what Jay said about the trick. I mean, obviously there's... There's obviously a lot of work that went into educating the site and the site educating patients that come to see them. We are using family practice, emergency care, and centers with patients with allergies, asthma, and COPD. So we launched a large campaign that tries to attract patients with clear understanding of the eligibility criteria for our study. And we were able to be successful in that sense, to attract patients with symptoms within our window.
Oh, there's no plans to increase the enrollment number.
Got it. Thank you really appreciate it.
Welcome.
Your next question is from Liisa Bayko with JMP.
Okay.
Hi, there I'm, just wondering if you're going to be doing any interim cuts of theme.
Our escapees study I thought.
That you needed some data in adult patients before moving into a pediatric so.
Just wondering how that's all going to work and if you're still that.
On time just started.
The end of this year.
The next as to how they're not they're a they're not really a interrelated and there won't be an interim cod. So.
I will will take the wealth of all the information we have and you know all the adults who have received.
Akash Tiwari: Got it. And just a quick question.
Study.
Unknown Speaker: Given the trial delay on the RSV side, is there any chance that you'd be looking at increasing the enrollment so you might suddenly have more of a flu-like total number of patients in your trial versus something more in line with other RSV, Phase IIb studies?
Doug and ER parlay that into our thinking about how we.
Those speeds ultimately, but in our expectation is that these studies would be run concurrently.
Okay. So after he doesn't need to see the data and and the adult population before starting the pediatric study.
Unknown Speaker: There's no plan to increase the enrollment number.
Oh no.
Unknown Speaker: Got it. Thank you. Really appreciate it. Your next question is from Liisa Bayko with JNP Security. Hi there. I'm just wondering if you're going to be doing any interim cuts for the RSVP Study. I thought that you needed some data in adult patients before moving into pediatrics, so just wondering how that's all going to work and if you're still on time to start it at the end of this year.
Okay got it.
And then could you maybe talk a little bit more about the differentiated profile of 297, because you mentioned it was differentiate and just be curious on learning a little bit more about that thank you.
Sure. So shifting gears to FX are now so to 90.
In our FFO on FX or agonists.
Spent a lot of time.
Trying to.
Optimize or whatever characteristics of the molecule we could.
You know, obviously looking at a high potency and selectivity in other kinds of things.
Jay R. Luly: No, they're not, they're not really interrelated, and there won't be an interim cut. So we'll take the wealth of all the information we have and all the adults.
What surprised us as you know with Threeo five in the Oregon study was at the doses that we used we saw more prior to us than we would've expected from all the information we saw in phase one.
Unknown Speaker: , , , , , , , , , , , , , ,
Unknown Speaker: Okay, so FDA doesn't need to see data from the adult population before starting the pediatric study.
Unknown Speaker: Unknown
Unknown Speaker: Oh, no. Okay, okay. Got it. And then, can you maybe talk a little bit more about the differentiated profile of 297? I mentioned it was differentiated. I'd just be curious. I'm learning a little bit more about that.
And and so for us.
[noise].
Thinking about how to use three or five.
In a way that gives a better tolerability going forward is is that you know the path. If we're thinking about for three or five but to nine seven then.
Jay R. Luly: Sure, so shifting gears to FXR now. So 297, or follow on FXR. We spent a lot of time. And I'm just trying to optimize whatever characteristics of the molecule we can. You know, obviously looking at potency and selectivity and other kinds of things. What surprised us, as you know, with 305 in the Argonne study was that at the doses that we used, we saw more paritis than we would have expected from all the information we saw in phase one. And so, for us,
It became clear is that.
Right as per.
Perhaps more so than than lipids.
The the thing we needed to really try to figure out how to.
Improve upon.
The confounding part of that is that nobody.
Nobody really understands what's causing.
Right.
Yes with these.
Curious FX ours that have seen it is that on target as it off target is it.
Jay R. Luly: Thinking about how to use 305 in a way that gives better tolerability going forward is the, you know, the path that we're thinking about for 305, but 297 then It became clear that, You know, pruritus, perhaps more so than lipids, is the thing we needed to really try to figure out how to improve upon. The confounding part of that is that nobody really understands what's causing pruritus in these various FXRs that have seen it. Is it on target? Is it off target?
On target in certain tissues, but not others.
And so absent having.
The you know sort of confirmed mechanistic understanding of how to.
To reduce brightness.
What we did was took other approaches that we could do sort of independent of knowing the mechanism. So number one.
Lets drill down the potency.
Who is as good as opposed to see is you could possibly do so we worked and worked and.
Jay R. Luly: Is it on target in certain tissues but not others? And so, without having, you know, a sort of confirmed mechanistic understanding of how to reduce paritis? What we did was take other approaches that we could do sort of independent of knowing the mechanism. So number one is drill down on the potency. So, I think, too, as good a potency as you could possibly do. So, we worked and worked and worked on that. We put the data out at JP Morgan, at least initially, and we'll have more at Eazl. But it's a very, very potent FXR. It's the most potent one based on the data that we've generated side by side versus any other FXR agonist that's in development today.
So now that Youve, we put the date out at JP Morgan was initially and we'll have more diesel.
But it's a very very potent.
FX starts to most potent one based on the data that we've generated side by side.
Versus any other.
FXR agonists.
It's in development today, so number one that's good because you will reduce the amount of drug.
The takes too.
To deliver the punch. So we we know that FX our receptors are.
And the intestine and also.
In the liver in terms of the sites of efficacy for a compound that we would be looking for Nash.
So in addition to.
Making these exquisitely potent for FX are and hopefully less potent for something else that we might not know.
Jay R. Luly: So, number one, that's good because you will reduce the amount of drug that it takes to deliver the punch. So, we know that FXR receptors are in the intestine and also in the liver in terms of the sites of efficacy for a compound that we would be looking for in NAC. And so, in addition to making these exquisitely potent for FXR and hopefully less potent for something else that we might not know, we aimed them directly at the liver and intestine, and not at plasma and skin. Because obviously, if you have high plasma levels, you're going to be circulating the drug around to all kinds of other tissues in the body. And we specifically thought it would be interesting to minimize the skin exposure of the drug as well. So it's really the two-fold combination of having.
We aim to directly at liver and intestine.
And not have plasma and skin.
Because obviously, if you'd have high plasma levels, you can be circulating the drug around to all kinds of other tissues and the body.
And we specifically thought it would be.
Interesting to minimize the skin exposure of the drug as well.
So it's really the count to fill the combination of having.
Very very good potency, so that will be dosing, just very small amounts of drug.
And then having that drug.
Go directly to the sites, where we need the drug and hopefully not at the sites, where we don't need the drug where only.
Only where only a other things could happen.
So.
That's our.
He says and.
Jay R. Luly: Very, very good potency, so we'll be dosing just very small amounts, and then having that drug go directly to the sites where we need the drug, and hopefully not at the sites where we don't need the drug, where only, you know, where only, you know, other things could happen. So, That's our thesis, and You know, there's a scenario where it might not play out as we hoped, but that sort of narrow scenario of bad luck, I guess, would be if it's FXR mediated. [inaudible] Then we may only have achieved, Transcribed by https://otter.ai
There's a scenario where.
It might not play out as we hoped but that sort of narrow scenarios of bad luck I guess would be if its FX our mediated.
The Pruritis NFX FX, our mediated by FX, our receptors inside the liver and.
None.
Then we may only have achieved.
The Super Super potent version of three or five where some of the other FX ours that are out there today, but if it's any other scenario.
We have the chance to.
Jay R. Luly: We have the chance to, you know, come up with benefits. And that's what we'll be exploring. We think we can learn actually a fair amount in phase one, and we're on track to start that phase one study in the middle of this year with, with the data coming in, in the first half of next year. So it's a pretty straightforward plan. It looks like an excellent molecule. Again, we'll profile More Ed Eisel. But, you know, it's a it's a polished entrant into the field.
To come up with.
And if it and that's what will be exploring we think we can learn actually a fair amount in phase one.
And we're on track to start that phase one study.
In the middle of this year with.
With the.
But the data coming in in the first half of next.
Next year, that's a pretty straight forward plan.
It looks like an excellent.
I'll kill Ken will profile.
More at EASL, but.
You know, it's a it's a it's a polished entrant into the field.
Unknown Speaker: Thank you.
Thank you.
Welcome.
Unknown Speaker: Welcome.
Brian Peter Skorney: Your next question is from Brian Skorney with Baird.
Your next question is from Brian Skorney with Baird.
Brian Peter Skorney: Hey, good afternoon everyone. Thanks for taking the questions. I guess first, just on EDP514, can you just walk us through how to think about the dosing here and where you want to target to maximize antiviral activity? If I look at the results you have in the chimeric liver-mouse model, it seems like dose escalation isn't really topping out, despite going to pretty high Mg per kg doses. Any thoughts on how to think about translating that data into a target?
Hey, good afternoon, everyone. Thanks for taking my questions I guess first just on GDP five on Fourq, just walk us through how to think about the dosing here and where you want to target maximize antiviral activity. If I look at a result, you haven't Cameron liver mouse model it seems like.
Dose escalation isn't really topping out despite going to pretty high.
Doses any thoughts on how to think about translating that into a party does inpatient.
Jay R. Luly: Yeah, I wouldn't, I wouldn't translate the rodent model numbers into humans. What I wouldn't look at in that And that experiment is. A very strong dose response and a very robust one, transcribed by https://otter.ai, that anybody has reported in that model. But in terms of comparing the doses in milligrams per kilogram for a rodent to the actual doses we'll use in humans, I wouldn't spend too much time thinking about that translation. And again, we'll get into the whole dose escalation work that we did at ESL when we lay out the whole data set out. And you'll be able to take a good look at it. A good look at it, then.
Yeah, I wouldn't I wouldn't translate.
The rodent model numbers into a to humans, what I wouldn't look at in that.
Now to experiment is very strong a dose response in a very robust.
Antiviral effect in fact, it's the most robust any viral effect that anybody has reported in that model. So.
But in terms of comparing the.
It was 10 milligrams per kilogram to erode and too.
The actual doses will use.
And ER and humans.
I wouldn't I wouldn't get spend too much time thinking about that translation and again, we'll get into.
The whole dose dose.
And work.
That we did that easel one we lay the the whole due to see that set out you'll be able to take a good look at it.
It could look at it.
Jay R. Luly: And then just if I could ask a question on patient flow in the RSVP study. Can you just remind us how screening works here? Are you just first primarily screening for patients with respiratory symptoms and then screening them in for RSV in the study? And do you have any data on how many patients come in with respiratory symptoms screen in for RSV versus screening out with influenza?
Great and then just one question on the Asian fall in the RSVP study you just remind us how screening works here are you.
First primarily screening for patients with respiratory symptoms men screening them in for RSV and the study and do you have any data on how many patients coming in with respiratory.
Some of them screen in for RSV versus bringing out with influenza.
Yeah. So.
Jay R. Luly: Yeah, so we take people again within 48 hours of symptoms, and there's an in-office PCR that's done. We look for RSV versus Flu A or Flu B. And if you're positive for RSV and negative for Flu A and negative for Flu B, then you're a potential candidate.
We take people again within 48 hours of sometimes there's an office PCR that's done.
We look for ours.
RSV.
Versus flew a or flu be.
And if you're a positive.
For RSV, a negative for flu a negative for flu b.
And or potential candidates.
Jay R. Luly: You know, obviously, I mean,
You know, obviously I mean a.
Jay R. Luly: There's more flu out there than there is RSV, so you're going to see more of that on these screens. But, you know, generally speaking, it's a straightforward presentation of people coming in within 48 hours, which again, we've seen many people coming in in that window.
Theres more flew out there than there is RSV, so you're going to see.
More of that in these screens, but.
Generally speaking it's a straightforward.
Test.
With the straightforward presentation of people coming in within 48 hours, which again, we've seen many people coming on and that window.
Jay R. Luly: I guess what I'm trying to get at is... If eventually this moves into sort of a seasonal RSV treatment, I'm trying to see if, in the real world setting, what sort of is a reasonable number to assume is a percent of flu, and we could obviously kind of compare it to what Tamiflu does, and a few others.
I guess I'm trying to get added.
Eventually this movement.
Sort of a seasonal RSV.
Freemen I'm trying to see.
The real world setting what sort of.
As a reasonable number to assume as a percent of.
When we get obviously compact.
Tamiflu dollars.
Got a feel for the commercial opportunity.
Yeah. It's.
Jay R. Luly: Yeah, it's. It changes every year, and it doesn't correlate perfectly every year. The seasonality is a little bit different, and what might be a more robust RSV season could be a lower flu season. So there is just this overarching
It's changes every you know it doesn't correlate perfectly every year or the seasonality is a little bit different and.
You know what might be a more robust RSV season could be a lower flu season.
As justice overarching seasonality to it.
Jay R. Luly: There is just this over...
Jay R. Luly: The patient numbers are probably not as high as, not as high as, the flu, but Again, I don't think people really fully know yet, in part because this, this testing is not routinely, routinely done on a, on a broad scale basis in clinical practice. So, and in part because it's not that the tests don't exist; it's that the drugs don't exist. So people don't often order up the test. It's also different, too, to be thinking about the patient demographic that's in the RSVP study, which is an adult outpatient study. We know adults in general are a fraction of what they are; adult RSV cases in general are a fraction of what they are in PEDS, so, you know, ultimately, the question will drive down to... Unknown Executive, Yasmeen Rahimi, Jay Olson, Jennifer Viera, Amy Li, Scott Rottinghaus, It's just a question of, you know, severity, and it's a question of... You know what happens once they get that infection.
The patient numbers are probably.
You know a.
Not as high as or not as high as flu, but.
Again, I don't think people people really fully know yet and part.
Because this does.
Testing.
It's not routinely.
Routinely done on a a on a broad scale.
Basis and clinical practice so.
And in part because it's not that the touched on it says is that the drugs don't exist. So people don't often a quarter up the test it's also.
Ah different to to be thinking about the patient demographic that certainly RSVP study, which is the adult outpatient study.
No adults in general or a fraction of what they are a adult RSV cases in general or a fraction of what they are a in peace. So ultimately.
The question will drive down too.
You know what are those or.
What are those Pete numbers, but there you know they're very significant NPS again every every every piece gets typically in RSV infection by the time their age two or three.
Just a question of a.
Severity and it's a question of.
You know what happens once they get that infection.
Brian Peter Skorney: Great, thanks Jeff.
Great. Thanks.
You're welcome.
Jay R. Luly: You're welcome.
And ladies and gentlemen, as a reminder, if you would like to ask your question at this time simply press Darren.
Operator: And ladies and gentlemen, as a reminder, if you would like to ask a question at this time, simply press star and then the number one on your telephone keypad. Your next question is from Patrick Truccio with Berenberg Capital Management. Hi, this is Iris Ong for Patrick.
Number one on your telephone keypad.
Our next question is from Patrick CTO Berenberg capital management.
Hi, just I guess on for Patrick Thanks for taking my question. So regarding ATP nicely eight can you tell us if you expect to evaluate the drug in elderly.
Patrick Truccio: Thanks for taking my question. Regarding EDP-938, can you tell us if you expect to evaluate the drug in elderly patients? And if so, would you move directly into a pivotal trial, or would you anticipate running maybe another two Phase II trials in this patient population? And then finally, would you anticipate having to run two pivotal trials for each patient population, or is one pivotal trial sufficient? Thank you.
And the sole which you move directly into a pivotal trial would you anticipate running maybe another two phase two trials in this patient population and.
And then finally would you anticipate having to run two pivotal trials for each patient population or it's one pivotal trial sufficient.
Unknown Speaker: Thank you for your question. I can address that. They are good questions.
Thank you.
Thank you for your question I can address that.
Good question, So I think one though we have.
Unknown Speaker: So I think for now we have informed patients that our next studies will be in transplant and PIDs. We know that those populations are really unmet medical needs. We are not excluding the possibility for the next future to be looking into the elderly, obviously, as they are also a population of good targets for RSV. But the plan for now will be to focus on the transplant and the PIDs. To your next question regarding pivotal studies, I think that's a very good question. Today, if you look at the guidance issued by FDA or EMA, I don't think there's a clear understanding of if we will need one or two pivotal studies like we usually do when we register a drug. I think it's going to be interesting to engage regulatory authorities as we move forward with our program. So we will know more as we, obviously, progress further.
Influence that Oh, Nick studies, we've been to transmit than Pete.
Oh, we note that this population really unmet medical need we are not excluding.
Full.
The next few tend to be looking into <unk>.
E. I'd also population of retail heat RV.
But the plants will now we'd be to focus on to transplant underpins to your next question are we getting people to touch that you think that's very good question today, if you look at the gate.
Then you should be indeed, Onea me I don't think there's a clear understanding of fleet. If we will need one or two people just city like we usually do when we just a drug I think it's going to be interesting to engage a regulatory until we do as we are moving again.
No problem. So we we know more as well.
With Uh Huh.
Okay got it and then regarding our SVP can you tell us what you would consider to be a highly successful the topline data resell.
Unknown Speaker: Okay, got it. And then, regarding RSVP, can you tell us what you would consider to be a highly successful top-line data result? Thank you.
Yes.
Well I guess [laughter].
Unknown Speaker: Well, I guess simply to meet the primary endpoint with a nice p-value; I'd be happy to see that. And, you know, I think RSVP is also an interesting study for us and maybe for the field, trying to understand the feasibility of how soon you can attract the patient with nasal symptoms that you can treat to prevent severity and progression to lower respiratory tract infection. And I think this is what we need to understand. And if we understand it and we can put that in practice, I think, you know, that would be probably half of winning a cure for RSV if we had a good product.
Good to meet the core millions goal is a nice P value [laughter] I'd be happy to see that.
And you know I think it I think you I think obviously be is also an interesting study.
And maybe for the field trying to understand the feasibility of how soon can you I tried to the patient we.
Nisan symptoms that you can treat to present CBLI in programs to know respectively, Trenton fiction and as he is what we need to understand and you can to study that we can put that impact either I think you know then we'd be probably have a winning a you know Q4 was easier.
Good product.
Unknown Speaker: Got it. Thank you. You're welcome.
Got it thank you.
Yes.
[noise] [noise] and there are no further questions at this time I'm trying to call back over to Miss Carol Miceli.
Carol Macelli: And there are no further questions at this time. I'll turn the call back over to Ms. Carol Macelli.
Operator: Thank you everyone for joining us today. If you have any further questions, feel free to give us a call in the office. Thank you.
Thank you everyone for joining us today, if you have any further questions feel free to give us a call.
And the office they can.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching. The Bulletproof Executive 2013, Copyright 2020, New Thinking Allowed Foundation.
Ladies and gentlemen. This concludes today's conference call. Thank you for participating can you may now disconnect.
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