Q4 2020 Trevi Therapeutics Inc Earnings Call
Operator: Good afternoon, and welcome to the Trevi Therapeutics Year-End 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require operator assistance, please press the star, then the zero key on your touch-tone telephone.
Good afternoon, and welcome to the Trevi Therapeutics year end 2020 earnings conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require operator assistance. Please press star.
And then zero on your touch tone telephone.
Operator: As a reminder, this call may be recorded. Various remarks that management makes during this call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Your results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent annual report on Form 10-K, which the company filed this afternoon.
As a reminder, this call may be recorded various remarks management makes during this call about the company's future expectations plans and prospects.
Forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed and the risk factors section of the company's most recent annual report on form 10-K, which the company filed this afternoon and addition, any forward looking statements.
Operator: In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its views change.
Representing the company's views only as of today and should not be relied upon as representing views as of any subsequent to date, while the company may elect to update these forward looking statements at some point and the future. The company specifically disclaims any obligation to do so even if views change. These forward looking statements should not.
Not be relied upon as representing our views as of any date subsequent to today participating on today's call from Trevi are Jennifer good President and CEO, Chris Snyder, Chief Financial Officer, and Bill Forbes Chief Development Officer, I would now like to turn the call over to Jennifer. Please go ahead.
Operator: Participating on today's call from Trevi are Jennifer Good, President and CEO, Chris Sider, Chief Financial Officer, and Bill Forbes, Chief Development Officer. I would now like to turn the call over to Jennifer. Please go ahead.
Jennifer L. Good: Good afternoon, and welcome to our fourth quarter and year-end 2020 earnings call. Joining me today on the call is Dr. Bill Forbes, Trevi's Chief Development Officer, and Chris Sider, Trevi's Chief Financial Officer. Bill joined us at the beginning of February with a proven track record of success in developing drugs and getting them approved. Under his leadership at Salix, he led the approval of 12 NDAs. I'm very happy to welcome Bill to the Trevi team, and he is available at the end of the prepared remarks for Q&A.
Good afternoon, and welcome to our fourth quarter and year end 2020 earnings call. Joining me today on the call is Dr. Bell Forbes, Travis Chief Development Officer, and Chris tighter Travis Chief Financial Officer sales joined US at the beginning of February with a proven track record of success and developing drugs and getting them approved and.
And their bills leadership at Salix. He led the approval of 12 N D A's and very happy to welcome Dell could the Trevi team and he is available at the end of the prepared remarks for Q&A.
Jennifer L. Good: 2020 was a challenging year for all of us on many fronts, but at Trevi, we remained focused on advancing enrollment in our clinical trials. We are motivated as a team to get to data readouts on our two lead indications in pruritus and cough, as we believe that the broad mechanism of action of Hadubio may be applicable to several other adjacent indications. Our lead indications include severe paritis in pariagonodularis and chronic cough in idiopathic pulmonary fibrosis, both serious diseases that cause significant quality of life issues for patients. We believe these diseases share a common pathophysiology through the mu and kappa receptors working both centrally and peripherally.
2020 was a challenging year for all of us on many fronts, but at Trevi. We remained focused on advancing enrollment and our clinical trials. We are motivated as a team to get to data readouts on our two lead indications in pruritus and costs as we believe that the broad mechanism of action on <unk>, maybe applicable for several.
Other adjacent indications our lead indications include severe pruritus in Prurigo, Nigel Erez, and chronic cough and idiopathic pulmonary fibrosis, both serious diseases that cause significant quality of life issues for patients. We believe these diseases share a common pathophysiology through the meal and capa.
Receptors working both centrally and peripherally.
Jennifer L. Good: Our most advanced program in clinical development is Paritis and Parigonodularis, or PN, which is a serious and debilitating skin disease characterized by papules and nodules on the skin, as well as incessant and severe itching. There are currently no approved therapies for this indication. Perigonodularis is a chronic disease, and because of the repeated scratching, the papules and nodules spread and continue to get worse.
Our most advanced program and clinical development is pruritus and prego, Nigel Arris R. P M, which is a serious and debilitating skin disease characterized by papules and non drove on the skin as well as and Samsung and severe itching and there are currently no approved therapies for this indication prego and agile Arris is.
And our chronic disease and because of the repeated scratching the papules and nodule spread and continued to worsen we estimate the global prevalence of Pn is approximately 730000 patients with 300000 patients and the U S and 430000 and the rest of the world.
Jennifer L. Good: We estimate the global prevalence of PN as approximately 730,000 patients, with 300,000 patients in the U.S. and 430,000 in the rest of the world. We are currently conducting a Phase 2B3 trial in this condition, which we call our PRISM trial. The PRISM trial is recruiting in both the U.S. and Europe, and to date, we have more than 60 sites activated.
We are currently conducting a phase two b three trial and this condition, which we call our prism trial. The prism trial is recruiting and both the U S and Europe and to date, we have more than 60 sites activated and the primary endpoint and the study is a responder analysis based on the reduction and itch intensity as measured.
Jennifer L. Good: The primary endpoint in the study is a responder analysis based on the reduction in itch intensity as measured by the worst itch numerical rating scale after 12 weeks of blinded fixed dosing. We have currently randomized approximately 240 of the planned 360 subjects into the trial. Encouragingly, almost all of the subjects that have reached the end of the blinded dosing period have chosen to roll into the open label extension portion of this study, enabling us to get long-term safety and efficacy data on these subjects. COVID-19 did negatively impact enrollment in this trial from December 2020 through mid-February 2021. As you likely saw in the news, many European countries were back on lockdown during this timeframe.
Probably the worst itch numerical rating scale after 12 weeks of blinded fixed dosing.
We currently have randomized approximately 240 of the planned 360 subjects into the trial encouragingly almost all of the subjects that have reached the end of the blinded dosing period have chosen to roll into the open label extension portion of this study, enabling us to get long term safety and efficacy data on and east.
Subjects.
COVID-19 did negatively impact the enrollment in this trial from December 2020 through mid February 2021 as you likely saw on the news many European countries. We're back on Lockdown during this timeframe and and the U S. Many people were staying home due to COVID-19 rates being so high across the country starting.
Jennifer L. Good: And in the U.S., many people were staying home due to COVID rates being so high across the country. Starting in mid-February, enrollment began picking up again, and to date, March has been a strong month, and we believe we are poised for continued momentum in this study. So I want to acknowledge the challenging past few months due to the impact of COVID-19 and know that to some extent, this will be a headwind we will continue to have to navigate through the end of this study.
And mid February enrollment began picking up again and to date March has been a strong month and we believe we are poised for continued momentum and this study so I want to acknowledge the challenging past few months due to the impact of COVID-19, and know that to some extent this will be a headwind. We will continue to have to navigate through the end of the study.
Jennifer L. Good: However, based on feedback we are receiving from the sites and good March activity, we still believe we can complete enrollment in the third quarter of this year and report top-line data by year-end. We also continue to be active at various virtual dermatology meetings. In mid-March, we had four abstracts slash posters that were accepted. These included a discussion of the role of mu and kappa opioid receptors in paritis, as well as posters on the Phase II clinical data in both paritis in PN and uremic paritis, providing clinical evidence that Buffine ER may now be important in managing chronic pruritus across a broad spectrum of conditions.
However, based on feedback we're receiving from the sites and good March activity. We still believe we can complete enrollment in the third quarter of this year and report topline data by year end.
We also continue to be active at various virtual dermatology meetings and mid March we had four abstracts slash posters that were accepted. These included a discussion of the role of new and Kappa opioid receptors and pruritus as well as posters and the phase two on the phase two clinical data and both pruritus and P and and Uremic pruritus.
Providing clinical evidence that now Bufete E R, maybe important and managing chronic pruritus across a broad spectrum of conditions.
Jennifer L. Good: We also plan to participate in both the American Academy of Dermatology's VMX conference in April and the European Academy of Dermatology and Venerology Spring Symposium in May. We have submitted abstracts for both meetings and are waiting to hear if they have been accepted. Turning now to our second clinical program for chronic cough and idiopathic pulmonary fibrosis, or IPF. IPF is a progressive and severe condition in which there is scarring of the lung tissue.
We also plan to participate and both the American Academy of Dermatology B M Axe and April and the European Academy of Dermatology and van or allergy Spring Symposium and May we have submitted abstracts for both meetings and are waiting to hear if they had been accepted.
Turning now to our second clinical program for chronic cough, and idiopathic pulmonary fibrosis or IPF IP.
<unk> is a progressive and severe condition in which there is scarring of the lung tissues and one of the leading debilitating symptoms of this disease is chronic coughing, which affects approximately 70% to 85% of these patients and for which there are no approved therapies.
Jennifer L. Good: One of the leading debilitating symptoms of this disease is chronic coughing, which affects approximately 70 to 85 percent of these patients and for which there are no approved therapies. IPS has an estimated worldwide prevalence of in excess of 1 million patients. In the U.S., we estimate that there are approximately 130,000 patients with IPF and an equal amount in Europe. Due to the high five-year mortality associated with IPF, prescribers and patients are not only looking to slow the progression of the disease but also improve their quality of life. Cough is considered one of the most bothersome symptoms for patients with this disease.
The PFS has on estimated worldwide prevalence and excess of 1 million patients and the U S. We estimate that there are approximately 130000 patients with IPF and an equal amount in Europe due.
Due to the high five year mortality associated with IPF prescribers and patients are not only looking to slow the progression of the disease, but also improve their quality of life cough is considered one of the most bothersome symptoms to patients with this disease. We are conducting a phase II double blind crossover study with a <unk>.
Jennifer L. Good: We are conducting a Phase II double-blind crossover study with a 14-day washout period between each three-week treatment arm. The primary endpoint assessment is the mean percent change in daytime cough frequency from baseline. The daytime cough frequency is measured by a digital cough monitor between the treatment and placebo arms.
14 day washout period between each three week treatment arm.
Primary endpoint assessment is the mean percent change and daytime cough frequency from baseline.
The daytime cough frequency as measured by a digital cough monitor between the treatment and placebo arms. This trial is currently being conducted and the U K and given that this patient group is considered high risk if they contract COVID-19 due to their lung impairment. This trial has been more impacted by COVID-19 restrictions then R. P M.
Jennifer L. Good: This trial is currently being conducted in the UK, and given that this patient group is considered high risk if they contract COVID due to their lung impairment, this trial has been more impacted by COVID-19 restrictions than our PM study. This trial resumed enrollment over the late summer, but the UK again shut down in early December and issued shelter-in-place directives to this patient population. Due to these restrictions, enrollment of new subjects was paused again.
Study this trial resumed enrollment over the late summer, but the U K again shutdown in early December and issued shelter in place directives to this patient population due to these restrictions enrollment of new subjects was paused again, we understand that these restrictions will begin lifting at the end of this month and we expect the try.
Jennifer L. Good: We understand that these restrictions will begin lifting at the end of this month, and we expect the trial to resume recruiting subjects in the UK in the second quarter of 2021. Additionally, Trevi is seeking regulatory and ethics board approvals to add study sites in Germany. The goal is to potentially accelerate enrollment and reduce the risk inherent in single-country recruitment during the pandemic. So, in closing, we are focused on completing enrollment in both clinical trials this year and reporting out the data. These are both serious conditions with no approved therapies, and we are motivated by the stories of patients about how disruptive these diseases are to their lives.
To resume recruiting subjects and the U K and the second quarter of 2021.
Additionally, trevi and seeking regulatory and ethics board approvals to add study sites and Germany. The goal is to potentially accelerate enrollment and reduce the risk inherent with single country recruitment during the pandemic.
So on clothing, we are focused on completing the enrollment and both clinical trials this year and reporting out. The data. These are both serious condition with no approved therapies and we are motivated by the stories of patients and how disruptive. These diseases are to their lives I.
Jennifer L. Good: I will now hand it over to Chris Sider, Trevi's Chief Financial Officer, to provide you with a financial update. But before I do that, you may have seen the 8K we filed this week that Chris will be leaving Trevi in April. In Chris's prior life, before becoming a CFO, he spent more than 20 years as an investment banker. So he has decided to take an interesting opportunity at a biotech fund where he will utilize his skills learned both in banking and operations. We will miss him for sure, but I wish him well with this next opportunity. With that, Chris, I'll turn it over to you for your final Trevi earnings report.
I will now hand, it over to Chris Cider Trevi as Chief Financial Officer to provide you with a financial update but before I do that you may have seen the 8-K, we filed this week that Chris will be leaving Trevi and April and Christmas prior life could be coming as CFO. He spent more than 20 years as an investment banker. So he has decided to take an interesting on.
Opportunity at a biotech from where he will utilize the skills learned volt and banking and operations, we will miss him for sure, but I wish them well with this next opportunity with that Kras and I'll turn it over to you for your final Trevi earnings report.
Chris Sider: Great. Thank you, Jennifer.
Thank you Jennifer.
Chris Sider: As a reminder, the full financial results for the fourth quarter of 2020 and the year can be found in our press release issued ahead of this call and in our 10-K, which is on file with the SEC. For the fourth quarter of 2020, we reported a net loss of $9.5 million compared to a net loss of $6.5 million for the same quarter of 2019. R&D expenses were $6.6 million during the fourth quarter of 2020 compared to $4.8 million in the same period of 2019.
As a reminder, the full financial results from the fourth quarter of 2020, a year. It can be found in our press release issued ahead of this call and our 10-K, which is on file with the OCC.
For the fourth quarter 2020.
And a net loss from that point.
$5 million compared to a net loss of six and a half million dollars from the same quarter of 2019.
R&D expenses were $6 $6 million during the fourth quarter of 'twenty, and 'twenty compared to $4 $8 million and the same period 2019.
Chris Sider: The increase was primarily due to increased activity in our Phase 2b3 prison trial, as well as an increase in expenses related to the purchase of clinical trial supplies. G&A expenses were $2.6 million during the fourth quarter of 2020, compared to $1.9 million in the same period of 2019. The increase is primarily due to an increase in stock-based compensation expenses and an increase in consulting fees. Now turning to the full year results.
The increase was primarily due to increased activity and a phase two b three prison trial.
And the increase in expenses with the purchase of clinical trial supplies.
G&A expenses were $2 $6 million during the fourth quarter of 2020 compared to $1 million from the same period of 2019.
The increase is primarily due to increase and stock based compensation expenses, and an increase and consulting fees.
Now turning to the full year results from.
Chris Sider: For the year ended December 31st, 2020, we reported a net loss of $32.8 million compared to a net loss of $26.1 million for 2019. R&D expenses were $22.3 million during the full year 2020 compared to $19.3 million in 2019. The increase is primarily due to the increased activity in our Phase 2b3 PRISM trial, as well as an increase in expenses related to the purchase of clinical trial supplies. G&A expenses were $10.2 million for the full year 2020 compared to $7.3 million in 2019.
The year ended December 31, 2020, we reported a net loss of $32 $8 million compared to a net loss of $26 $1 billion for 2019.
R&D expenses were $22 $3 million during the full year, 2020 compared to $19 $3 million and 2019.
This was primarily due to the increased activity and a phase two b three prison and trial as well as an increase and expenses related to the purchase of clinical trial support.
G&A expenses were $10 $2 million from full year, 'twenty, and 'twenty compared to $7 $3 million 2019.
Chris Sider: The increase is primarily due to an increase in stock-based compensation expenses, an increase in consulting fees, as well as increased expenses related to being a public company. As of December 31st, 2020, our cash and cash equivalents totaled $45 million, compared to $57.3 million as of December 31st, 2019. Subsequent to the end of 2020, we sold approximately $4.4 million of our common stock through our ATM facility. The current cash position is expected to be sufficient to fund operations into the second quarter of 2022, past the anticipated top-line results from the prison trial, which are expected in the fourth quarter of 2021. That is all for our prepared remarks. Now we'll turn the call back over to the operator for Q&A.
Increase was primarily due to an increase and stock based compensation expenses and and.
Increase and consulting fees as well and increased expenses related to being a public company.
As of December 31, and 2020, our cash and cash equivalents totaled $45 million compared to $57 $3 million as of December 31, 2019.
Subsequent to the end of 2020, we sold approximately four $4 million of our common stock through our ATM facility.
The current cash position is expected to be sufficient to fund operations into the second quarter and 2020 to pass the anticipated top line result from our prison trial, which are expected in the fourth quarter of 2020 one.
That is all from our prepared remarks, now I will turn the call back over to the operator for Q&A.
Operator: Thank you. If you have a question, please press the star and then the one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We ask that you please limit yourself to one question and one follow-up. One moment for our question. Our first question comes from the line of Gary Nachman from BMO Capital Markets. Your line is now open.
Thank you if you have a question. Please press the star and then the one key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key we ask that you. Please limit yourself to one question and one follow up one moment.
And for our questions.
Our first question comes from the line of Gary Nachman from BMO capital markets. Your line is now open.
Yeah.
Gary Nachman: Hi, good afternoon. And first, my best to you, Chris, and welcome to Bill and Trevi. So a couple on PRISM, any additional sites you think you'll need to add in order to complete the study in the third quarter, given the COVID headwinds? And I don't know if you want to be specific about that number, Jen, where you are right now. And then follow-up; how have the discontinuation rates been? Anything out of the ordinary that you're seeing? And how are the AEs looking so far, I guess, broadly across the entire study?
Hi, Good afternoon, and first my best to you, Chris and welcome to Bill and joining Trevi.
So a couple on prism and any additional sites you think you'll need to add in order to complete this study and the third quarter, given the COVID-19 headwinds and I didn't know if you want to be specific about that number Gen where you are right now.
And then follow up how is the discontinuation rates been anything out of the ordinary that you're seeing.
And how are the he is looking so far I guess broadly across the entire study.
Jennifer L. Good: Yeah, thanks Gary. I'll go ahead and let Bill answer that since he's sort of fully at the helm here in the study. Go ahead, Bill.
Yeah. Thanks, Gary I'll go ahead, and let bill answer that since he sort of fully at the helm here of the study go ahead Bill.
Bill Forbes: Hi Gary. So let me let me give you a few thoughts. I mean, I think the thing that we anticipated first was, you know, questions around how confident we are about hitting these timelines. So there's a number of things that we're looking at for the PRISM trial. I mean, we feel like the COVID cloud might be lifting a little bit. Particularly if you take a look at Germany; we have our prison study operating there, and we're getting some good enrollment in Germany.
Hi, Gary.
So let me let me give you a few thoughts.
The thing that we anticipated first was no questions around how confident are we about hitting these timelines. So there's a number of things that we're looking at for the prison and trial I mean, we feel like the COVID-19 cloud might be lifting a little bit, particularly if you take a look at Germany. We have a prism study operating there and we're getting some good and.
Bill Forbes: And Germany has been on our radar because there's been some talk about them possibly closing back down. But so we're cautiously optimistic on the COVID front as it relates to these centers. And so we've seen over the last month, as Jennifer mentioned in her comments, we've seen some good activity. The competition within the centers, we feel like we're in a good space there. It seems like some of the competitors may be leaving, and others are maybe a little slow, at least at this point in time, in getting initiated.
And in Germany, and Germany has been on our radar because there's been some talk about them, possibly close and back down, but so we're cautiously optimistic around the COVID-19 front as it relates to these centers and so we've seen over the last month as Jennifer mentioned in her comments, we've seen some some good activity the competition within the centers and we feel like we're on a good spot.
There you know it seems like some of the competitors, maybe exiting and and others are maybe a little slow at least at this point and time and get and initiated so we feel like our centers are focused primarily on our prism study on.
Bill Forbes: So we feel like our centers are focused primarily on our prison study. Operationally, we continue to stay focused on whatever resources and support we can provide to our investigators. And then when it comes to the investigators and the coordinators, they have a lot of confidence that they can hit the timelines that we're laying out to them. Along the lines of the question that you asked, are we gonna add some centers? And the answer to that is yes; we are in the process now of adding some high-quality centers. Not a lot of them, just a few of them.
Operationally, we've continued to stay focused on what are what whatever resources and support we can provide to our investigators and then when it comes to the investigators and the coordinate coordinators, who have a lot of confidence that they can hit the timelines and we're laying out to them along the lines of the question that you ask is how are we going to add some centers and it and he answered that is yes.
And the process now of adding some high quality centers not a lot of them just a few of them. We've been very selective about who we're going to add to the prism study at this late stage that we feel like they really and we pushed them hard and the selection process to make sure that they feel they can contribute in the window of time that we've got in front of them.
Bill Forbes: We've been very selective about who we're gonna add to the prison study at this late stage, and we've pushed them hard in the selection process to make sure that they feel they can contribute in the window of time that we've got in front of them. So you also asked about study disposition type things. I'm not gonna comment on the study disposition. I will say, as it relates to adverse events, the adverse events that we've seen previously are pretty much the same adverse events that we see in the ongoing studies. The nausea, the headache, dizziness, somnolence, those types of adverse events that we know are associated with malnutrition are what we continue to see.
You also asked about study disposition type things and I'm not going to comment on the study disposition I will say as it relates to adverse events.
And you know the adverse events that we've seen previous are pretty much the same adverse events and we we see on the ongoing studies the nausea, the headache, dizziness, somnolence and those those types of adverse events and we know are associated with no abusing her.
What we continue to see.
Jennifer L. Good: Okay. If I could just squeeze another quick one in. Did you say, Jennifer, that, I want to make sure I got this, that in chronic cough, you still think you can have that data by the end of the year as well, despite all the challenges there?
Okay.
And just to squeeze another quick one and did you say Jennifer that.
I want to make sure I got this net and chronic cough do you still think you can have that data by the end of the year as well despite all the challenges there.
Jennifer L. Good: Yeah, it's a good question, Gary. So we pulled our formal guidance, as you probably remember, when COVID hit, and we've never put it sort of formally back up again. Because to be honest, I don't think at any point we've ever felt we sort of made our way through that yet. Internally, we are striving to get this enrolled by year end. It's not a big study; it's up to 60 patients with 44 completers. So we'll see, I will just keep updating you on that. We didn't sort of put up formal guidance again, but we are striving internally to try to get that by year end.
Yeah. It's a good question Gerry so we pulled our formal guidance as you probably remember when Covid hit and we've never put it sort of formally back up again because to be honest I don't think at any point, we've ever felt we sort of made our way through that yet.
Internally, we are striving to get this enrolled by year and it's not a big study it's up to 60 patients with 44 Completer. So we'll see we'll just keep updating you on that we didnt sort of put out formal guidance again, but we are striving internally to try to get that done by year end.
Jennifer L. Good: Okay, I got it. Thank you. Yeah. Yeah. Thank you.
Okay got it. Thank you yeah, yeah. Thank you.
Operator: Yeah, yeah, thank you.
Annabel Eva Samimy: Thank you. Our next question comes from the line of Annabel Samimy from CFO. Your line is now open.
Thank you. Our next question comes from the line of Annabel for me and me from Stifel. Your line is now open.
Annabel Eva Samimy: Hi, thanks for taking my question. Congratulations, Chris, on your move.
Hi, Thanks for taking my question.
Congratulations Chris on.
Jennifer L. Good: Just a couple quick ones for me, just on the, I know you didn't really comment on the discontinuation rate, but the strategies that you had put in place to manage that discontinuation rate, are they at least working the way you expected them to work? And have you been able to maintain patients on treatment in a way that you had expected? And then, you know, in terms of those patients going on OLE, what is the longest the patient has been on therapy during that trial?
On your move.
Just a couple of quick ones from me just on the I know you didn't really call. It on the discontinuation rate, but the strategies that youre putting in place.
To manage that discontinuation rate are they at least working on the way you expected them to work and have you been able to maintain patients on treatment.
And and or whether you would expected and then you know in terms of those pitches going on oil and what is the longest the patients have been on therapy during that trial, and then separately and IPF and is there any thought to expanding it took place outside of Europe. It seems like Europe is pretty tough right now.
Jennifer L. Good: And then separately, in IPF, is there any thought to expanding it to sites outside of Europe? It seems like Europe is pretty tough right now with the lockdowns and the restrictions. Any thoughts to bringing it over here to the U.S., where things are a little bit more open? There have been a few IPFs, some more IPFs. [inaudible]
With the Lockdowns and restrictions and he thought.
And just to bring it over here to the U S where things were a little bit more open there had been a few ips.
More IPF.
Jennifer L. Good: So I'm going to go ahead and answer this, and you feel free to add color after, you know, at the end if you want.
Trials, the stop the kidney and so maybe there's more availability here.
Yeah.
So I'm going to go ahead and answer that and you feel free to add color. After you know at the end if you want so annabel as you know we had talked early on about there are various levers built into that surround managing discontinuation. So its really has to do with education and society at the patient level and you know if things early on appear well sort of.
Jennifer L. Good: So, Annabel, as you know, we talked early on about there being various levers built into this around managing discontinuations, which really have to do with education at the site, at the patient level. You know, if things early on appear, we'll sort of follow back up on things. I would say all those are active and appear to be working.
Follow back up on things I would say all of those are active and appear to be working I mean, the hard thing and I think my bill doesn't want to get into any commenting it's really hard and a blinded studied and know what's going on but yes. There's nothing there that's overly alarming I think it's something we always have to manage through but yes. The strategy I think the things we've put in place seem to be working.
Jennifer L. Good: I mean, the hard thing, and I think why Bill doesn't want to get into any commenting, it's really hard in a blinded study to know what's going on. But, yes, there's nothing there that's overly alarming. I think it's something we always have to manage through.
And as far as the open label I think your question was what's the longest that we have seen patients on we have a lot of patients and that type of 50 that have gone through a year of treatment. So it's on a nice job of building our safety database Theres a lot of efficacy data. There I think one of those priorities is to get in and start sort of mining that open label data, but we've had.
Bill Forbes: But, yes, I think the things we put in place seem to be working. As far as open label, I think your question was, "What's the longest that we've seen patients on?" We have a lot of patients, in excess of 50 that have gone through a year of treatment, so it's done a nice job of building our safety database. There's a lot of efficacy data there. Bill, anything you want to add to those comments? No, I think you covered it. I mean, obviously, titration.
Really good success with the rollover into the open label and with people people continuing on throughout that portion of the study and as far as moving IPF and the U S. We went to the U K because theres very good expertise there I think that's still the case. So we haven't looked at that at this point I think we think we can get it done in Europe and that.
Still the strategy to try to follow through on that so anything you want to add to those comments.
Bill Forbes: No, I think you covered it. I mean, obviously, the titration phase. I think, as we look at it, to Jennifer's point, it's blinded. It's hard to really know how these patients are divided between the treatment groups, obviously. But, you know, I think that we're encouraged by what we're seeing at this point in time as far as how the patients are progressing through the double blind. You get into the open label, and I have had a chance to take a closer look at that data, and that's very encouraging as well. So, I mean, obviously, you know, in a blinded study, it's hard to make comments. But, you know, I think for the most part, this thing is behaving the way that we expect it to.
No I think you've covered it I mean, obviously the titration phase I think you know as we look at it to Jennifer's point is blinded it's hard to really know you know how these patients are divided between the treatment groups, obviously, but you know I think that we're encouraged by what we're seeing at this point in time as far as you know.
The patients are progressing through the double blind you get into the open label and I haven't had a chance to take a closer look at that data and that's very encouraging as well. So I mean, obviously you know on a blinded study its hard to make comments and but you know I think for the most part this thing is behaving the way that we expect it to.
Great. Thank you.
Operator: Thank you. Again, if you have a question, please press star and then the one key on your touch tone telephone. Our next question comes from the line of Serge Belanger from Neidham and Company. Your line is now open.
Thank you Annabel.
Yeah.
Thank you again, if you have a question. Please press star and then the one key on your Touchtone telephone.
Our next question comes from the line of Serge Belanger from need him and company. Your line is now open.
Yeah.
Serge D. Belanger: Hey, good afternoon. I have a couple of questions about prison for you. Well, I guess first, congratulations and good luck to Chris on his new opportunity. For the prison trial, I think last time we spoke, you were talking about maintaining a monthly enrollment pace of 20 to 30 patients. It sounds like that's dipped around the holidays and late in the year due to COVID, but do you think you can get back to those levels as soon as March and going forward? And then there is the second question. With the delays in the IPF trial, does that change how you think about the LID program and whether you would think of advancing it forward?
Hey, good afternoon.
Couple of questions for on and prison for me.
Well I guess first congratulations and good luck to Chris with the new opportunity.
For the present trial I think last time, we spoke you talked about and maintaining a.
Monthly enrollment pace.
20 to 30 patients.
Sounds like the dips are around the holidays, and Lady and the year due to COVID-19, but because he can get back to those levels as soon as.
March and going forward.
And then second question.
With the delays with the IPF trial does and does that change how you think about the <unk> program and whether you would.
Think of our advancing and forwards.
Jennifer L. Good: Yeah, so I'm going to let Bill definitely comment on enrollment. I would just say there are 120 subjects left. So, you know, trying to get there by Q3, that's roughly 20, sort of over the next six months. So I'll let Bill comment on that. But Bill, let me finish with the lid, and then I'll turn it over to you.
Thanks.
Yeah, So I'm on a lot and they'll definitely comment on enrollment and I would just say there's 120 subjects lap. So you know trying to get there by Q3, that's roughly 20 sort of over the next six months. So I'll, let bill comment on that but they'll let me finish for the land and then I'll turn it over to you and so third I think as we've talked about before we really when COVID-19 hit.
Jennifer L. Good: So Serge, as we've talked about before, we really, when COVID hit particularly hard, we made the decision here that we were going to bear down on our two lead programs and get to date on those. We still very much are interested in the LID program and have done some good work to get ready for a phase two program. We've written a protocol, we've selected a CRO, but we won't pull the trigger on that study until we actually see data from both of these studies.
Particularly we made the decision here that we're going to bear down on our two lead programs and get to date on those we still very much are interested and the Allied program and have done some good work to get ready for a phase two program. We've written a protocol and we selected a C. R O, but we want them to pull the trigger on that study until we actually see data on both of these studies.
Jennifer L. Good: So still very much interested, but we want to get up to date on both these programs. I think mostly because, I mean, you can sort of, you know, understand the thinking. We want to basically pursue the best option. If the data is strong in PN, we want to make sure whatever we're adding is another indication that makes sense with PN. If the data is super strong in IPF COF, we may want to look at other COF indications.
So still very much interested but we want to get the data on both these programs I think mostly because I mean, you can't sort of you know understand the thinking.
We want to basically pursue the best Optionality. If the data is strong and P and we want to make sure whatever we're adding is another indication makes sense with P and if the data is super strong and IPF costly may want to look at other cough indication and so all those things will sort of be laid against each other so well wait until we have that and we know what we've got and then we'll make those decisions.
Jennifer L. Good: So all those things will sort of be compared against each other. So we'll wait until we have that and we know what we've got, and then we'll make those decisions. Bill, I'm going to let you just comment on sort of enrollment and numbers and what you think you can achieve. Yeah, no. I think you're right.
I don't know what you just comment on sort of enrollment and numbers on what you think you can achieve.
Yeah, No I think you're right surges that are you know we were looking at 20 to 30 per month, we feel confident right now with what we're seeing is February wrapped up and then March of course seem to be a very strong month for us because if we can continue this momentum at this point and.
Bill Forbes: Yeah, no, I think you're right, Serge, that we were looking at 20 to 30 per month. We feel confident right now with what we're seeing as February wrapped up. And then March, of course, seemed to be a very strong month for us, as if we can continue this momentum at this point in time.
Bill Forbes: And that's why I made some comments about what we thought of, you know, the situation broadly around PRISM when Gary asked his question earlier in the call. So I feel like those are the types of numbers that we're targeting are somewhere in the 20 to 30 range. And obviously, we hope that we can, you know, exceed those and we can move forward on this. But, you know, we're cautious on this. And as I said, you know, we're looking at a number of things.
Time, and it's why I made some comments about what we thought of the situation and broadly around prism when Gary asked his question earlier on the call.
So I feel like those are the types of numbers that we're targeting and somewhere in the 20 to 30 range and and obviously, we hope that we can.
And exceed those and and we can move forward on this but I'm cautious on this and as I said you know we're looking at a number of things. So if we look at the Covid situation as I said it seems to be easing itself and so that's certainly helping quite a bit and.
Bill Forbes: If we look at the COVID situation, as I said, it seems to be easing itself. And so that's certainly helping quite a bit. And, you know, along with all of our initiatives that we're doing at the centers and adding a few centers, I think that we should be able to accomplish.
And you know along with all of our initiatives that we're doing at the centers and adding a few centers I think that we should be able to accomplish this.
Operator: Thank you. I'm not showing any further questions. I would now like to turn the call back to Jennifer Good for closing remarks.
Okay.
Thank you Serge.
Thank you I'm not showing any further questions I would now like to turn the call back to Jennifer good for closing remarks.
Jennifer L. Good: We would like to thank everybody for participating in today's call. I'd also like to thank the Trevi team, our study investigators, and all of the subjects who continue to participate in our clinical trials during this challenging time. We look forward to continued progress and updating you again in May. Thank you.
We would like to thank everybody for participating on today's call I'd also like to thank the Trevi team our study investigators and all of the subjects, who continue to participate and our clinical trials. During this challenging time, we look forward to continued progress and updating you again in may and thank you.
Operator: Thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.
Thank you for participating on today's conference. This concludes today's program you may all disconnect everyone have a great day.
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Okay.
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