Q1 2022 Aptinyx Inc Earnings Call
Cash balance of $100 million too.
To enable data readouts from each of our three ongoing phase III programs over the next 18 months.
Very happy to say that there's broader pipeline remains fully on track and over the last few months, we have made meaningful progress across all of our other programs with MRI X, 295% and fibromyalgia with the 50 milligram dose of NYSE 783 in PTSD and with NOI up to 45 age and cognitive impairment.
Therefore poised to reach several major milestones in the months ahead.
Thanks to our team's continued excellent execution. We currently expect data readouts from NYSE to 95% in fibromyalgia in July or August of this year.
From NYSE 458 in cognitive impairment in late Q4 of this year or Q1 2023.
From NYSE 783 in PTSD in the second half of 2023.
Let's discuss our clinical programs in more detail beginning with NY extra 95.
We began 2022 with N Y X 295 under evaluation in two chronic pain indications painful diabetic peripheral neuropathy or VPN and fibromyalgia.
As I mentioned in April we announced the results from our Phase <unk> study.
Unfortunately, the study did not meet its primary endpoint of separation from placebo on the zero to 10, NRM pain rating scale at 12 weeks compared to baseline.
Overall, the data did not show a clear clinical benefit of daily dosing of 50 milligrams of NY extra 95 relative to placebo and do not justify a path forward in this VPN indication.
This result was obviously very disappointing and certainly not what we'd hope for.
We based the phase <unk> study on data and analyses from our previous Phase Iia study and VPN.
We of course always knew that pain and VPN is initiated by an underlying progressive peripheral pathology.
But we had a biological hypothesis supported by data from our previous study that's super spinal brain based pain processing abnormalities become a significant characteristic overtime and VPN.
This led us to reevaluate the centrally acting mechanism of <unk> 95 in a specific subset of longer disease duration VPN patients in the phase <unk> study each of whom had experienced neuropathy symptoms for four more years.
Since the data from this study suggests that even long standing pain originating from peripheral neuropathy is not an appropriate disease for a mechanism to target. We made the decision to discontinue our development and painful VPN going forward.
And my next 295 is also currently being evaluated in a phase <unk> study in patients with fibromyalgia.
In contrast to painful DPM fibromyalgia is not classified as a peripheral neuropathy and is instead widely thought to be a centralized pain state and which super spinal pain processing abnormalities are rising in the brain or a primary characteristic.
Based on prior preclinical and clinical data, we've shown that Nyse's 295 operated by modulating NMDA receptors and key brain regions responsible for cognitive control of pain and pain perception, which presents a compelling biological rationale for evaluating nyse's 295, as a treatment for fibromyalgia.
Unfortunately, we will not have to wait long for the data from this phase <unk> study in.
In order to determine if these differences and underlying biology, and mechanistic rationale compared to DPM can yield a different positive result.
The phase <unk> study in fibromyalgia completed enrollment in February of this year and is on track to report results in just a few months' time in July or August .
The study is assessing N Y X 295, as a monotherapy without other concomitant analgesics over a 12 week treatment period.
We feel these design choices are in line with regulatory requirements for future pivotal studies.
We're testing daily dosing of 50 milligrams of N Y X 290, 500 milligrams of <unk> 95, or placebo over 12 weeks of treatment.
The primary endpoint in this study is the change from baseline to week 12, and patient reported average daily pain averaged over a week and evaluated using the zero to 10 numeric rating scale or <unk>.
Alongside changes in average daily pain additional endpoints will also measure the impact of fibromyalgia symptoms on daily function as well as changes in other symptoms such as fatigue and sleep.
The study is powered to detect an effect size that is clinically meaningful.
Depending on the degree of variation seen with pain scores that powering would be consistent with somewhere between five and seven difference or greater between NY X, 295% and placebo on the zero to 10 scale.
Next steps. Following this study would include an end of phase two meeting with FDA to discuss the requirements for phase III NMDA.
We remain optimistic about this program not only because of the strong biological rationale impressive clinical data supporting its development, but also for the opportunity to deliver a novel therapeutic solution to the over 8 million underserved patients living with fibromyalgia in the U S alone.
Let's move now to our next clinical program evaluating <unk> 73 in patients with PTSD.
In December of last year, we initiated a phase <unk> study evaluating 50 milligrams of <unk> 783 versus placebo.
Study will enroll approximately 300 patients and evaluate them over 10 weeks using the <unk> total score as the primary endpoint.
The 50 milligram dose level of NY at 703 were selected based on the signals seen with that dose on the caps five scale over just four weeks of treatment in a previous phase Iia study.
Certain design parameters were incorporated in our follow up phase <unk> study to help mitigate potential placebo responses and the overall design was finalized following a type C meeting with the FDA to discuss the requirements for a pivotal study in this indication.
Based on early enrollment trends in the study we expect to be able to report data in the second half of 2023.
We had also planned to initiate a second phase <unk> study to evaluate higher 150 milligram dose of <unk> 73 in patients with PTSD with a design very similar to that of the 50 milligram study.
As I mentioned previously we announced last month that we will temporarily pause the initiation of this 150 milligram phase <unk> study.
Decision was driven by two main factors first is the ability to preserve capital and enable our existing cash balance to deliver readouts from each of our other in process clinical trials.
Second is the ability to focus our efforts in PTSD on the 50 milligram study we had experienced a few challenges in initiating clinical trial sites on schedule and our PTSD studies due to a number of other studies in this indication being conducted in the U S across the industry.
While we believe we have addressed these challenges focusing our efforts should additionally de risks our ability to enroll a 50 milligram study within our planned timelines.
At the time of the pause the 150 milligram study had not yet begun screening or enrolling patients.
<unk> of the sites that we're planning to contribute to the study will now shift their focus to the 50 milligram study.
We remain enthusiastic about studying the higher 150 milligram dose in this indication and we'll make the decision to recommence. The study as soon as we believe it makes financial and operational sense to do so.
In addition to our progress in the clinic. We've also published additional preclinical data demonstrating the positive effects of NY at 708, three and model is relevant to PTSD and the <unk>.
April edition of the journal molecular psychiatry with.
This data further characterizes the therapeutic potential of NMDA receptor modulation to treat the learn fee or in distress, commonly associated with PTSD.
These preclinical data were also recently presented during a symposium discussion at the society of biological Psychiatry with annual meeting in New Orleans earlier in May and they will also be presented at the upcoming American Psychiatric Association meeting later in the month.
Let's move on to N Y X 458, our product candidate in development for the treatment of cognitive impairment associated with Parkinson's disease, and dementia with lewy bodies.
Enrollment in our exploratory phase II study in this indication has progressed at a steady rate since the start of the year.
We continue to expect to report data either towards the end of this year or in the first quarter of 2023.
This is a first in patient study designed to assess safety and to detect a signal of the activity of N Y X 458 on measures of cognitive performance.
While the study is exploratory and primarily signal finding we believe it is robustly designed to detect a therapeutically meaningful signal.
The study is a double blind randomized parallel design study planning to enroll approximately 100 patients that will receive daily dosing of either 30 milligrams of <unk> five eight or placebo over a 12 week treatment period.
Given the novel mechanism of N Y X 458, we're evaluating multiple cognitive endpoints in this study in order to characterize the activity across the critical cognitive domains of attention memory and executive function.
Not only are these domains characteristic of cognitive impairment in Parkinson's disease, and dementia with lewy bodies, but they are known to be NMDA dependent phenomenon.
This program represents an exciting opportunity to address a major unmet need in cognitive impairment and we hope the data from this study will be a significant step towards achieving that goal.
With that I will now turn the call over to Ashish to review, our first quarter financial results.
Thank you Andy beginning.
Beginning with the balance sheet. We ended the first quarter of 2022 with $102 million in cash and cash equivalents.
Compared to $106 $1 million at the end of 2021.
Our Q1 2022 cash figure was inclusive of $10 million from the second tranche of our capital credit facility, which we drew down in March.
As Andy outlined earlier.
The recent cash conservation measures on our PTSD program.
We expect our current cash balance to provide extended operating runway into 2024.
Over the course of that runway, we expect data readouts from each of our three ongoing clinical studies.
The majority of our spend during the quarter was focused on research and development related to our ongoing clinical studies across chronic pain cognitive impairment and PTSD.
R&D expenses were $13 6 million for the first quarter of 2022 compared to $10 3 million for the same period in 2021.
We reported G&A expenses of $4 9 million for the first quarter of 2022.
<unk> to $5 million for the same period in 2021.
We had zero revenue for the first quarter of 2022 compared to $1 million for the same period in 2021.
Our revenue in 2021 was derived from our research collaboration agreement with Allergan now a subsidiary of Abbvie, which came to its contractual conclusion in February 2021.
Finally, our net loss for the first quarter of this year was $19 8 million.
Compared to a net loss of $14 2 million for the same period in 2021.
I'll now turn the call back over to Andy.
Thank you chase.
As you can see despite our disappointment with the deep and results. We've also made great progress across our clinical pipeline.
Our balance sheet that can support a steady stream of upcoming data readouts and a committed team with a strong track record of executing even in a challenging external environment.
We remain optimistic and excited about the potential of our pipeline as we approach the second half of 2022 and our next readout in fibromyalgia in July or August we will be happy to begin taking your questions now.
Thank you we will now begin the Q&A session, if you'd like to ask a question. Please press star followed by one on your telephone keypad.
If for any reason you would like to remove that question. Please press star followed by two.
To ask a question press Star one, we'll pause briefly to allow questions to generate income.
The first question is from the line of retail morale with Cowen you May proceed.
Good afternoon, guys. Thanks for taking the question.
A question on the readout for planned 25, copper mountain readout coming up.
You mentioned that you are first looking at the NRA.
You're also looking at activities of daily living.
I'm, sorry daily function fatigue, and fleet is there any scientific rationale for a potential larger separation fatigue.
Given the mechanism versus.
Centralized pain and so.
So has there been any discussion or any <unk>.
<unk> guidance.
That could present, a separate alternate path to approval.
It is.
Versus team.
Yes, Thanks Ritu.
So in terms of potentially being the ability to generate a larger delta.
There's a there's a mechanistic rationale I think for the molecule.
Being able to improve more symptoms than just pain I think that's obviously why we're interested in and measuring them I don't think there is enough.
No data to say that.
There is a reason to believe they should be larger but I think there is certainly we certainly have an interest in measuring them and believe that there could be potential there.
The second part of your question is a little bit unknown.
The approved agents for fibromyalgia have all been approved on the basis of patient reported pain endpoints.
But there is some precedent for the fibromyalgia impact questionnaire being included in the label of approved products. That's really all we know so we haven't had a discussion with FDA about that.
And so I think that that remains TBD I think our perspective is based on our conversations with clinicians that.
There is more to fibromyalgia and pain and some of these other symptoms in particular fatigue sleep can be very bothersome to patients.
So we would hope that.
Any benefit that patients got from the drug during the study.
It could be reflected or could be captured.
As part of a pathway to approval, but I think our base assumption right now is that.
As our primary endpoint and pain is the prior precedented pathway to approval.
Yeah.
Great.
Any comment just on general conduct.
Any loss I'm sorry.
Dropouts or a data integrity issue.
Due to the latest wave of Covid in that study.
I think it's tracking in a similar way operationally to.
The way that the DPM studied it in that in that we didn't see in that study any operational issues and I think so far in fibromyalgia.
Most of the study parameters have been tracking in line with our expectations.
Great. Thanks for taking the questions.
Thanks Ritu.
Thank you. The next question is from the line of Charles Duncan with Cantor Fitzgerald You May proceed.
Yes, hi.
Andy and Ashish thanks.
Thanks for taking our questions I actually had a couple of questions.
Following up on some debt to wear was working on and and that is I guess I wanted to follow up on 292, five and ask you about the fibromyalgia conduct the study of that are the kind of Tibet study I guess.
So im wondering if theres anything that gives you confidence in terms of how that study has gone in terms of dropouts or anything else and then secondarily with regard to fatigue and sleep are you are you tracking on a blinded basis kind of the feedback from.
Patients as they report.
Some of the I guess some of the information and how they feel well on the drug over the course of the 12 12 weeks.
Yes, Thanks Charles.
Yes, I think so.
My comments at a high level on the Fibromyalgia study is that yes, I think we feel.
Good in terms of what we see operationally that everything looks to be on track.
I just wonder if we do have a kathryn king on the line, who as you know as our SVP of clinical and CMC operations, Kathryn and I just wanted to give you a chance to see if you have any more comments on just on the study conduct.
Yes, I agree with you Andy I think we're seeing.
Quality of data that we review on a blanket.
In a blinded way, we're having good conversations with our banks about protocol with Kieran and I think that in general we're proceeding I think that in a way that we would have expected.
Great. Thanks, Thanks, Katherine and then with respect to sorry go ahead Jonathan.
Please I was listening to you.
So I think with respect to the second question.
Just to clarify what you're asking are you asking so I think we don't.
Half.
A format, but I think we would be able to make a meaningful comment on any feedback or data in a blinded sense from the study so far.
On fatigue and sleep, but.
But just to clarify what you meant we are we are obviously collecting endpoints that measure those and in addition, obviously measures of global improvement as well over the course of the study. So I think once we do have.
The data unblinded, we will be able to get a fairly clear picture over which symptoms improved over time and the relative.
<unk> of one symptom versus another.
Okay, and then if I can ask a follow up for you to compare and contrast, peripheral pain versus centralized pain.
I guess I'm wondering if pain precedes fatigue, and sleep challenges or fatigue and sleep challenges proceed.
Pain.
Yeah, I E would you expect.
An improvement in fatigue in sleep.
Short of period of time, and when you report out that data will you be prepared to be able to demonstrate.
<unk> data.
Not only pain data about fatigue and sleep data over on a.
Weekly basis over the course of the study.
So I'll answer the second part and then I may have heard we also have Harold.
Mark on the line Who's our VP of medical and clinical affairs. So I might have him speak to the relative time scale of the pain and fatigue and sleep, sometimes I think our endpoints are measured slightly different time points, because as you probably recall the patient reported pain as captured on a handheld device that the patient has with.
At home every day of the study so we can analyze data from every every day every every week so so.
So that's a more continuous basis.
Most of the other non patient reported pain endpoints are captured.
Study visits which are most commonly.
To be monthly data points, so there'll be a little bit of a time course, but not as granular, but Harold do you want to comment on to sometimes themselves the time course.
It is not known about fibromyalgia, but.
But.
Indiana.
I mean, what we know is it similar brain regions involved in the perception of pain and sleep regulation.
And there is quite a bit of into extra sleep deprivation used to a change in pain threshold on the Orlando. If you have pain of course, who have sleep disturbances, but from a clinical perspective as far as we know from the literature.
Things can happen, one or the other way paying can start or be more prominent or fatigue and can be more problem and I think it's not that clear.
Specific sequence, which would identify let's say a subset of patients you have to look at all the data and find out.
Okay. Thanks for taking the question, let's look forward to.
Data.
Talking about it tomorrow.
Thanks Charles.
Thank you. The next question is from the line of Joon Lee with true Securities You May proceed.
Good evening. This is often on for gena and thanks for taking our questions I guess sort of just continuing on 2925 do you think that people being outside more nowadays.
Walking more given the more lax COVID-19 restrictions.
Might have reduced at separation from placebo on the IRS scale in your D. Pn study.
So interesting question I think.
The enrollment period for the study for the most part ran.
From around.
Q4 of 2020 through too.
Basically Q1 of.
2022, and if you take the whole treatment period into our current so it was quite a long time period and there were different ebbs and flows in.
<unk>, probably behavior and certainly in Covid restrictions.
Background.
Factors over that time, those factors were probably difficult little bit different by geography, depending on where you were in the U S. So I think it is in practice very very difficult to ascribe.
Such a.
<unk> time period, and the geography of where there is a lot of inconsistency on those factors, it's probably very difficult to.
To see if any of those really made a difference.
I would say I don't think we've heard any clear consistent feedback about our single trend and.
<unk>.
And therefore really not not any connection being made between any trends that we're seeing them and the results. So it's just a very hard.
Topic to to look at because there's so much variation.
Do you think Thats something you might look into.
For your Fibromyalgia study.
Again, I think it would be equally difficult the treatment.
Enrollment and treatment period was very similar which started up just a few months later and finished a few months later or so.
You've covered a similar I think diversity of time periods and geographies and so forth. So it's.
It's probably quite difficult I don't know if Catherine or Harold do you have any thoughts on whether that's even a possible analysis, but I think it would be quite challenging.
Hi.
Yeah.
In addition to what Ed.
I think the here.
Exercise as a therapeutic modality for fibromyalgia patients also very quietly.
So how come in on a pretty prescriptive exercise program and some will have not.
So their baseline consistent with respect to activity would also be.
Something will have to be factored into an analysis like that but I think in terms of the COVID-19 impact on activity again, we're across a very wide range of time in a very wide range of geographies here in the U S where things were.
Okay.
Al.
Okay adjustment to make that decision.
Good point that Barry abilities, hopefully taken cowboys around the integration within these trials the oily affect us which cannot be very well defined and I hope the randomization.
We have a number of subject group is sufficient for that we take care of that.
Alright. Thank you so much for the color on that guys.
Just one more question if I can ask given the negative update on VPN, how does that impact your K two financing deal.
Yes, Jason you want to cover that.
Sure. Thanks, Andy.
There really is no impact.
The tranches.
But we have drawn down on the debt financing.
Our drawn down upon initiation in September of last year.
And more recently in March of this year.
Neither one was dependent of course on.
On <unk>.
<unk>, which which came thereafter.
Those two tranches accounted for $25 million of the $50 million total facility the remaining 25%.
Is dependent upon.
The coming data readouts and milestones across our pipeline.
Okay highly appreciate it. Thank you all for taking my questions.
Thank you.
Okay.
Thank you. The next question is from the line of Myles Minter with William Blair You May proceed.
Hi, Thanks for taking the questions just on the <unk> study did you actually do any analysis on drug exposure levels in <unk> patients to make sure that they achieved optimal exposure. So was there anything that we should know about compliance on this product.
And how are you tracking that proactively and the fibromyalgia study that's my first one.
Okay, Cathryn do you want to cover that.
Yes, there was.
Hey measured in the trial analytically.
Very high level of compliance with study drug after Apple trial impact the tolerability profile lends itself to adherence to daily dosing and the subjects. So encounter OCA pack was quite high in the Saudi and what's interesting is that have impacted our results.
And you gave that compliance number as a percentage.
I don't have that kind of impact.
This is all good.
The next question is just on off qualify by it and the mild cognitive impairment trial, just on the potential efficacy signals there.
Hoping to see stabilization of these patients on the neuro stock index that you're measuring there or are you, hoping the same proven over 12 weeks I'm just wondering whether that is long enough and how that.
Pacific parameter.
<unk> change in these patients on placebo versus on drug and what you.
Looking forward there thanks.
Yes, that's a great question miles and actually quite quite an important one I think for the drug its business profile and the study design. So.
We are expecting to see an improvement in cognition in those patients with the drug that's what the mechanistic rationale would suggest and that's what we saw if you remember in our in our preclinical data that some.
<unk> been subsequently published in <unk>.
Non human primates, and the MPTP model.
We saw quite a marked improvement in fact I think in all of the cognitive assays that we've run pre clinically we saw we saw an improvement in.
So it is it is a symptomatic improvement mechanism, we do think 12 weeks as long enough to see that.
Although of course, there can be some practice effects over time with some of these tests, we've taken steps in the study designed to try to mitigate those practice effect.
Patients have to repeat the test.
During screening and baseline a number of times. So there's a lot of the practice effect has occurred by the time they start.
The studying proper.
And various other things like that but it is a symptomatic improvement hypothesis.
Turning to <unk> as you mentioned just sort of delaying decline is typically what we would see with a disease modifying drugs.
And that has historically taken after many many months too.
To show a benefit because you essentially it's the rate at which the placebo group declines that is determining the ability to separate so that's not our hypothesis.
And as a result, we do think that 12 weeks is adequate time to kind of signal here.
Okay. Thanks for the questions.
Thanks, Mike.
Thank you.
The next question is from the line of Gary Nachman with BMO capital markets. You May proceed.
Hi, Thanks for taking our questions.
<unk> on for Gary.
So my first question on two nine to five.
Are there any key learnings from the chronic pain study that you can help modified for the fibromyalgia study and.
And secondly can you just talk about the protocols are in place to help mitigate a potential high placebo rate in that study.
I have a follow up after this as well.
Yes, that's great let me quickly.
Quickly cover the first point and then maybe Catherine can weigh in on the placebo.
Part of the question, where there are a number of measures.
That are in place.
The.
The overall learnings that can be applied at it. So in terms of the study of course. The fibromyalgia study is really the last few patients are working their way through the treatment period right now so.
There is no ability to modify the study nor I think that'd be really see anything that.
Gave us a clear with it.
Would have given us a clear basis to make a modification even if there was time. So I don't think that's a concern we have.
The only thing that we could theoretically have done is to make modifications to the analysis plan, but actually I think again I don't think we saw anything that gave us a clear basis to do that and in addition, as I pointed out in the remarks earlier the underlying biology.
<unk> is very different between the two.
Orders spanned the presentation and the patients are very different as well and so actually quite a lot of what we're analyzing and fibromyalgia. Although it follows kind of similar principles is a little bit different too.
Hi.
The endpoints that we are in the DPM study. So I think if we had seen or anything that was a clear lesson learned they place we could have applied it was the analysis plan, but in practice we didn't.
And I think we are quite comfortable that both the study design on a specific analysis. We plan we have for fibromyalgia are both appropriate.
Kathryn do you want to cover that placebo point.
Sure. So we provided training to our sites at our investigator meeting in that study start up meetings.
Two.
Really established what is a research alliance with patients as opposed to the therapeutic alliance where patients are expecting to get better.
We also provided training on an ongoing basis throughout the trial for all patients.
Placebo response reduction that is reminding them that they are part of a clinical trial that their data is important to us in evaluating these compounds and that it is possible that they're on placebo those reminders that proven effective in let me call it managing.
I can see Nf trial.
We provided training for accurate pain reporting.
Giving patients how the scale of the at our at work.
Reminding them what each of the documents that they are reporting I mean, so average pain worst pain pain on walking.
And again, we used that to ensure that we were getting accurate pain responses from patients throughout the trial.
That was done for VPN and similarly for fibromyalgia trial.
Got it.
I can follow up.
Four 738 and PTSD.
Are there any modifications to the <unk> study following the pause about 150 Mg study.
Why not just.
Include 150, Mg and <unk>.
In that study and increase the number of patients enrolled.
Thanks.
Yes, so no there arent modifications to the 15 milligram study as a result of the 150 milligram study being.
Temporarily pause.
I think changing fundamentally the approach to a three arm study with introduced quite a number of other.
Issues.
Since part of our motivation was to preserve our.
To extend our cash runway.
Yeah.
If we were to change the design of the study to incorporate two doses and still allow it to be within our cash runway to only way, we could accomplish that would be to reduce the number of patients per arm.
And in addition, there are actually quite a lot of significant operational and logistical complexities to changing those things in a study that would probably have meant that it would take a little while.
To go live anyway, and as I mentioned in the remarks, our goal is still to restart the other study as soon as it's financially and operationally feasible to do so so I think in thinking it through our feeling was that the best approach.
Sure.
And multiple scenarios is to do it in this way to keep the 50 milligram study going as it is simply pause. The 150 milligram study and then resume it when we're able to that probably is the best way to balance.
Our objectives there.
Got it thanks, Thanks for taking my questions.
Thanks, Adam.
Thank you <unk>.
Next question is from the line of Ram Silverado with HC Wainwright you May proceed.
Okay.
Hi, This is Adam on for Rob Hello, Andy and the team.
So with respect to the 295 program given.
The DPM readout as this.
Opened up additional resources for fibromyalgia component in terms of study site capacity equipment personnel et cetera.
So.
Fiber Myalgia study was so far along by the time, we got that data that there wasn't really any need for that at a fully enrolled in February and so.
The last round of patients is is making their way through the study right now in that number of course is declining.
Over time down to whenever the last patient last visit as that will be.
In a little while so.
So there was really no no need to do that so the fibromyalgia study.
<unk> is in good shape in additional resources.
Arent necessary.
Okay, and then in terms of the <unk> readout now have a more focused understanding that the trend is centrally acting and not necessary to chronic pain conditions with AR.
<unk> peripheral input if you will.
Other chronic pain conditions, you could target with a large bring level processing component for example, central pain syndrome, which is a rare disease the CNS sensory pathways.
Yes, that's a great question I think.
Exactly right. So we previously had.
Our perspective that.
There were.
A range of different follow on indications and I think we said we pointed to the general space and kind of set the particular follow on indications that make the most sense would depend on the data that we got from these two phase <unk> studies. So I think yes pending the fibro data in July August if that study is positive I think that would certainly open.
The door to some follow on indications it would be a different group of follow on indications.
And then if the DPM study had been positive, but there still is further opportunity. So we definitely would be.
Obviously.
<unk> committed to and interested in.
Figuring out exactly.
What those indications are and what priority order and how we pursue them, but thats definitely still a part of our plan.
Okay, Great and just finally are you able to give us some indication.
Completions getting sites up and running for the 70 350 milligram study.
I think what I would say is that it is.
It is.
Basically close to being complete so I think.
As I mentioned there are still some some sites that we're planning.
Planning to take part in the 150 milligram study that are being moved over to the 50 milligram study, but I think whereas on the last call. I think we commented that it had been a little slower than we had.
As I mentioned again today.
A little slower than we'd been expecting in terms of getting sites up and running I think we're certainly turning the corner from that now and I think once these sites have moved over.
We will have the sites that we need to we already have a majority of the sites up and running and I think that with this we will.
Be in pretty good shape.
Okay much appreciated thanks for taking my questions.
Thank you.
Thank you.
Next question is a follow up from Myles Minter with William Blair You May proceed.
Hey, just a follow up on this SaaS.
So the fibromyalgia study.
How exactly is that pre specified <unk> in terms of the hot Raphael or do you go to placebo versus the 100 milligrams.
The NRL schools and stepped through some secondary outcomes before you go to placebo versus 50 or do you go for an individual endpoint and placebo 100, and then placebo versus 50.
Just ask because.
The fibromyalgia impact questionnaire.
Might be included in the label if this thing is positive.
Wanted to know how far down the pecking order that is in terms of what we can expect for the statistical test. Thanks.
Yeah. Thanks, Myles so thats a good question so just to be clear if you recall our prior fibromyalgia study was an imaging study.
Involving 23 subjects and it was very informative from a biological perspective, and a clinical point of view, but it didn't give us the basis to do a complete dose ranging look and it also doesn't really give us a basis to estimate with precision the likely effect size from any of these endpoints. So this is going to be a little bit more of.
<unk>.
From our.
Perspective.
A little bit more of a exploratory type of analysis. So we would look at the two different doses.
Non hierarchical way and we wouldn't have a rigid hierarchical step through the different primary or secondary endpoints, we made that decision.
Basically because we felt it was.
<unk> made more sense, because we didn't have enough of a basis to design the hierarchy.
In addition, we always said although this study is designed following some of the guidance for what a pivotal study needs to look like but it was not our base plan.
For for this study to necessarily have to be a pivotal study. So I think with all of that.
We felt as though at a more exploratory analysis makes more sense based on based on what we currently know.
Okay that makes sense.
And if you say a signal here.
The.
Maybe a pivotal study based on some additional commentary with the FDA, but the base case, I guess would be select the best starts to move forward and gone run two identical placebo controlled trials one to one randomization with fat concentration job is that why do you think thats exactly.
That's exactly right, yes, that's it that's exactly right. It's not out of the question I think the way we buy.
I'm thinking about it is not out of the question.
Study could in the right circumstances potentially be pivotal.
But it's not the baseline and and you're right it would be.
It would be really used to inform the design and even if it were a pivotal study we still need to do.
At least one more.
It would serve as a basis for designing that study as you pointed out.
Okay. Thanks for the follow up.
Thank you.
I am showing no further questions at this time I'd like to turn the call back over to Andy for any closing comments.
Thank you very much. Thank you for joining us we look forward to providing you with the with our next update in the future and I Hope that you all have a great rest of your day.
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