Q3 2021 Galmed Pharmaceuticals Ltd Earnings Call
And 53% elevation in exposure and optimized treatment duration for our encore.
Government also added to the study a rigorous and robust technology reading process.
Firm and designed in consultation with the FDA, including a committee of three independent experienced liver pathology.
Biopsies are read by each pathologists individually followed by a consensus Sweden.
The data, which will be soon presented by professor Russell is aligned with the hypothesis that higher RMB per dose, resulting an improved efficacy profile and that direct anti fibrotic effect of our own coal may occur as early as 24 weeks.
This is demonstrated by histology and corroborated by fibrosis Biomarkers.
Analysis of Biomarkers in the larger outcomes cohort support anticipation at further biopsy analysis will continue to show at our uncle treatment provides a highly meaningful effect on fibrosis.
Importantly, our encore continues to show excellent safety and Tolerability profile.
Now, let me transfer the call to Professor Russell <unk> shortly.
Thank you Alan.
Im always honored and very happy when I had when I can get to present positive results. So thank you for inviting me to do so today, so hello, everyone.
I hope you can see the slides we have prepared for you here.
I would like to start by reiterating what.
And on behalf explained very well, which is that this is.
And innovative.
Ah study, which was designed within the.
Randomized controlled trial the phase III trial of the armor study and this is an open label part which tests and.
Three different durations of exposure to AMCOL as explained.
Six months duration of 12 months duration and the.
18 months duration in three groups of patients or 50 patients. Each it is an open label study.
We know basically.
The rate of response in terms of fibrosis, the reduction of the placebo arm from the many studies that have been conducted and reported so far so the interest of the study is not the comparison with placebo, but rather to understand whether changing the chemical.
<unk> of the drug.
By delivering it twice a day, which increases as you were told.
Considerably the exposure in blood.
This results in higher level of histological effect.
Then what was previously tested and published in the Phase II trial.
Moreover, the study we'll try to understand what would be the optimal period of treatment that resulted in a strong anti fibrotic effect and for that reason the three period length of the three durations.
Are being compared.
Maintaining fleets now the study will continue after the respective 612 or 18 months.
Time, where a control of liver biopsies being performed and it will come.
Continuing the same open label fashion.
It is.
Scheduled to end around the same time as the randomized controlled phase III trial, RMR will end and the only difference here being that only patients who are non responders. We will have a third biopsy in order to understand whether.
Prolonged exposure.
Beyond the initial time lines.
Will result in a anti fibrotic response Ah.
Delayed anti fibrotic response in people who are initially non responders. So this is a very exciting design because it does several things at the same time and usually things that are not.
Being tested in traditional phase two b or phase III trials, because like always everybody wants to to rest of the year to take the shorter routes to success.
But here it is important to understand very well how to use these drugs now another thing that.
Mr. <unk> explained is that nowadays a single pathologist is no longer sufficient. So therefore it is important to have.
A very strong histological adjudication process and in agreement with the FDA and what was decided and what is being implemented for this trial is to have a committee of three pathologists. So it's no longer just one deciding whether it works or not but the three of them need to agree and provides a total consensus.
On the staging integrating of the disease and that is of course done blindly not to the allocation. Because this is open label, but to the sequence of the biopsies. So the pathologists do not know whether they're reading the first or the control biopsy. So all of this is explained here on the slide I'm going to move on.
Now to present you the preliminary results on the first two patients that have completed their assigned a lot of time of exposure.
We're very happy to tell you that the results that were part of the results that were presented here have.
Have been accepted for presentation as a late breaker at the liver meeting the American Association studies the meter disease meeting.
It will be held later this week. So the part that has been submitted and accepted as a late breaker concerns.
Concerns 20 patients and is labeled here late breaker as L D.
But then it will also present the.
The data.
It's available today of the larger cohort of patients that participate in this open label study, which by the way it's called outcome called open label.
Ah study and this is the <unk> cohort and these concerns 139 patients. So the 20 patients that are being presented as already are part of this 139.
So you can see here on this slide that are basically the the epidemiology and the demographics are pretty much the same between the first 20 and the subsequent 119 you can see here that females are a majority of the patients. The mean age is around 58 years.
I was rather high 32 to 33, and then ethnicity, there's a majority of caucasians.
Most patients have advanced bridging fibrosis stage III between 67% and 65%.
And then there are some.
<unk> are at two and others that are stage one.
So this is as far as the baseline characteristics.
And now is the main results you can see here the proportion of patients that had an improvement by one stage or more after exposure to coal.
And.
Apologies the good news is that actually out of 20 patients that had a control liver biopsy.
12 of them had a fibrosis reduction by one stage or more and actually seven by one stage in five by two stages.
There is a quite remarkable result, because that places the level of response in terms of fibrosis improvement at 60%.
And of course this is very impressive compared to the figures that are available in the literature because by all accounts the placebo rates in the different studies is between 15 or 13, even in the phase III trial, and I would say, 30% maximum so 60% goes way beyond that of course.
These are preliminary results on a small number of patients, but this high level of fibroids reduction has not been seen so far in other studies.
What is interesting here you can see on the right part of the diagram.
How these biopsies are distributed.
Regards to the length of exposure, so basically half of the patients.
At least an equal number nine of them have been biopsied. After one year and nine of them have been biopsied. After six months and two of them only have been biopsy biopsy at week 72.
And so you can see that and there is for the moment numbers are too small to see a trend, but it looks like 48 weeks would would have the best response rate in terms of fibrosis.
With 67% of them six out of nine improving fibrosis by one stage or more but they support it needs to be confirmed as the trial continues. So these are the very exciting histological results.
A more visual way to see the changes.
Changes in the liver of patients treated with AMCOL is are these pie charts show on the left side before at baseline on the right side after treatment and two things are quite striking to your if you look at the proportion of patients with bridging fibrosis.
Orange.
You go from 65% or shrinks down to 25%.
That's what the numbers indicate 13 here in five years.
Conversely, if you look at the number of patients with very early fibrosis stages. So the blue ones have once this goes from this increases from 15% to 45%.
When you put together edge Julien so clearly there's a shift here in terms of fibrotic severity.
That is being induced by exposure to alcohol.
Now if we're looking at.
Verging evidenced on Biomarkers, which is always very important.
Because we would like to see all needle moving in the same direction now what you can see on this slide here is the response on animal transference levels.
So on so ALC on the left side as you know on the right side top graph is from the late breaker cohort 20 patients.
And the bottom part and this is interesting is all patients included so far so which has been now we looked at different lengths of exposure and not all of them completed.
The.
But the results.
Our accumulative of the different types of exposure.
And the important part here is that both enzymes both of them in all kinds of things that go down as you can see here clearly a significantly.
Significantly and this is true whether you're looking at the first 20 patients are at the subsequent.
139 patients that were included and analyzed in total so far so quite robust reduction which is confirmed beyond the initial 20 patients which are reported at the liver meeting.
Now if we look at specifically at some.
Very popular fibrosis markers, let's look at Q4, there again the results are.
Very.
Encouraging in the English in the sense that they go in the same direction as the results observed by histology.
If you look at it on the left side you have the S. L. D. Late breaker cohort of 20 patients a clear drop in before and this is replicated in the larger cohort of 139 patients that behavior is the same so one can surmise from that that is the logical result.
When this will be available from the RFP from the entire cohort.
I'll be quite similar to the one obtained in the small earning a cohort of 20 patients of course this needs to be seen but the fact that three before it goes down and all of the patients. If this is an indicator of fiber was reduction it should and histological results should be.
The same on the larger number of patients which is of course.
The final result that we're looking for in this study now looking at.
Another very emerging biomarker of fibrosis, which is proceed three it.
It is.
A marker of not only of established fibrosis, but also active fibrogenesis.
Because it is a fragment of pro collagen that is being relieved as collagen is being deposited in the tissue. So proceeds III now every trial measures proceed threep and what is here also reassuring is that in the in the 'twenty.
<unk> when they break or a cohort of 20 patients where histological regression of fibrosis hasnt been documented by liver biopsy you can see a strong reduction in proceeds suite.
But that is also replicated.
Export feed poor in the larger cohort of 139 patients reached not everyone has a liver biopsy yet.
But the fact that these biomarker or a fiber James goes down makes us think that the Easter logical trend will be the same in the larger cohort and whether you look at absolute change or a relative change the results are quite consistent.
It is interesting here is that proceeds three was measured by Nordic Bioscience, which is the biotech company that initially.
Uh huh.
Invented and created this biomarker.
However, they did change.
The methodology for measuring it.
Assayed precisely and that resulted in a more robust and more reproducible assay. According to the two Nordic Biosciences, and also to a higher baseline level, which is.
Explained here of $48 eight micrograms per liter.
Now if we look at the.
Statistical significance of the results that I've just shown you.
Whether you're looking at I mean, with <unk> and the two most popular fibrosis markers you can see that there's a significant drop from baseline.
We just showed here on this slide and this is true at week 24, and it is maintained at week 48 with a high level of significance for all of the Biomarkers that are being presented on the slide so again I'm going to transfer agents fit for and proceeds.
As a reminder, the asset the late breaker cohort documented proportion of patients who had a reversal of fibrosis was 60%.
So the Wow. These results important is because they confirm and actually go beyond what was demonstrated in the phase II trial, which is called the arrest study and the results of which has been published in extent so in a very prestigious medical journal, which is nature.
Medicine.
Less than one month ago. So.
The reserves are representing currently today.
Reinforcing.
Optimism in the in the ability of this molecule to induce a histological improvement and in particular, a fibrosis reversal. So that's why it is always good to have.
The same results.
Coming from a different cohort.
So this is why this study is important to conduct and also they they do support.
The effect of the higher dose arm coal, which is the one actually that is being will be used in the phase III <unk> study. So the practical implication of these results. If they are confirmed on the larger cohort of the of the open label trial is that they will.
Enable us to conduct discussions with the FDA, so that the interim analysis of the phase III trial, which.
Which is the analysis that if positive.
Allows for a conditional marketing authorization. So it allows us to negotiate that these interim analysis is performed on a smaller number of patients and maybe after a shorter period of exposure say for instance, instead of 70 248 weeks.
Which will of course be an important thing because that will help bring the drug earlier to the market.
Very positive initial results so far from this open label trial and I'll pass it over to you Alan.
For the question and answer session.
Well. Thank you. Thank you Professor Russell and we will open the floor now for Q&A for Professor Russell and then we will continue with our regular coding.
Thank you at this time I will be conducting a question and answer session for professor Rockdale.
I would like to ask a question. Please press star one on your telephone keypad.
You can call. It indicates the blinded in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.
Our first question that we had.
It's from the line of Steve seat House.
Please proceed with your question.
Hi, there this is Ryan deschner on her Ccs.
Wanted to see.
If any of the patients in these cohorts are receiving any other therapies like vitamin E vehicle it is outside rates or anything like that.
And then also where the patient's consulted on lifestyle management.
Eating well exercising more et cetera. Thank you.
Yes. Thanks. So this is a.
This is akin to all the other studies being conducted in the field Ah patients are allowed to be on other medications, particularly the ones who are specified.
If they have been on that medication for an extended period of time.
Before the biopsy that was the initial biopsy was taking the biopsy that.
It's used for randomization.
Because of the assumption like for all the other trials is that if you have taken vitamin D or pure lives on for a number of months or years, and then you have a liver biopsy that showed that give nash with fibrosis that means youre not a responder. So that particular medication. If you if the patient was started that medication only a few weeks.
Before he did before.
The.
Selection does it then of course they were not allowed in the study. So all these patients can be considered as non responders to.
<unk> or vitamin E now.
It doesn't mean, it's not even the market in some European countries and the use of vitamin D is actually pretty low including in the United States I cannot give you the exact numbers of those that are on these medications, but.
What is important is that they are basically equivalent non responders to these drugs now you're also asking about diet and lifestyle measurements. So here again like all the other trials in Nash people are given the information they're educated about what they need to change in their lives.
And their diet and exercise they are doing or not doing and they're constantly being reminded that in each study visit.
But there is no.
[noise] systematic ancillary program of implementation of the dietary and lifestyle changes I'm not aware of any pharmacological a trial that does that so it's actively enforcement.
But it's no more than that of course any changes in weight any changes in alcohol consumption any changes in the.
The amount of activity are captured at each visit and this will be one of the founders that will be taken into consideration when analyzing the final results on the effects on histology.
Got it thank you very much.
Yeah.
And our next question comes from the line of Ed Arce with H C. Wainwright.
Proceed with your question.
Hello, everyone. This establishes your basket and a couple of questions for Ed Congratulations very exciting open label data so far.
There's a couple of questions.
Yes.
Among the five patients who achieved a two point reduction in fibrosis as we've seen in corpus right.
Approximately what time point, what's that achieved and when should we expect.
The next set of biopsy data from.
The larger archiving cohort.
So thanks Thomas.
Don't have the exact detail of the five patients.
Maybe government has it whether that was <unk> 24, 48, I think it's quite equal in between the groups, but with the small numbers I'm not sure we can move them.
I'm confident about that.
So are these results will be given now that for the next.
So the study is ongoing so there are each week there are people who have their lives their second biopsy taken.
So this well will continue with we hope that the next time.
We report findings on this cohort it will be when the first 50 patients instead of the current 'twenty will reach the end of treatment biopsy. So then we'll have a picture of a larger picture on the number of patients that is.
Higher than the one presented sure. So 50 patients. So I don't know when that exactly what will happen, but we hope.
This can be available by the time, we hold easel next year. So so I hope that we can we can show you more data at that time.
Okay got it.
But over the next year.
And that's just wanted to confirm for the power marker data analysis that was presented today.
The ASR was a cohort of 20 patients.
The overall open label archive cohort.
39 patients or are they separate cohorts.
No. The 20 patients are part of the 139.
Cohort that is that I presented there either.
Oh, okay. So so so that data of approximately 50 patients of the open label overall.
Does contain.
Okay that'd be cool.
Okay and it contains additional patients that have been followed for variable periods of time some of them only four weeks other eight weeks of the 12 weeks, but repeated measurements.
Methodology that has been used takes into account the individual period of exposure for each one of these 139 patients in the graph was built using these data.
Alright got it.
So the last part about the study.
About the demographic so far.
We see that over 77%.
Patients enrolled in the open label.
Our female patients assessed by decide or and also do you expect it to be perpetual effect.
No it's absolutely not by design it happens to be that way actually if you look at most studies at least most trials that have been published so far there is a majority there are there is a majority of women maybe.
Maybe not 77% is more like 60, 65%.
But that is in fact, the majority of women as.
There's always something that we see in the series.
Okay understood.
So much for taking my questions.
Thanks, David.
Sure.
Thank you.
Our next question comes from the line of Kristen <unk> with Cantor. Please proceed with your question.
Hello, This is Rick on for Kristen.
Could you. Please discuss how you look at the importance of time to onset and these results, particularly in comparison to other announcements in the Nash space.
Portance do you believe the time to onset could ultimately have for physicians and patients.
I'm, sorry, so you're saying time to onset, Germany, the duration of exposure in the trial.
24.
Joe.
Yes, that's correct yes.
So what we're just.
We're just trying to understand the dynamics of the anti fibrotic.
Potency of the drug.
Because it kind of will happen you know that your you have people who are.
For one particular drug that respond much earlier than let's say no you can have one particular drug which has a.
Much earlier response, and other drugs that you need to use for a longer period of time to obtain the same result, so that's that's one thing some let's say some drugs act very fast others very slowly that's one thing.
Other thing.
And we don't know, which one is AMCOL because all the studies that have been performed so far for all of the drugs, including alcohol to phase two b trial. They only have one fixed period of time, the only trial, where we tested two would we do.
Serial biopsies, so that to understand the dynamics.
To understand if there was an earlier or later responds with any pivotal trial.
We performed one year two years, but in all the other trials as just one fixed time period. So you don't know whether you're at the maximum of the effect or if you're at the time point, we're just starting to see the effects.
So in order to get a better understanding of how this drug acts on fibrosis.
Other aspects of liver injury.
It is good to have more than one time point to understand the kinetics of the response. That's one thing. The second thing is that there is individual variability so there might be early responders.
And late responders people, who need to be treated for a longer period of time in order to have a response. So that also is the basis for comparing three different time periods three different lengths of exposure.
So that's all and of course, if the results are clear enough.
If we see for instance that you already reach the maximum.
Response level say at 48 weeks.
And at semi and prolonging by six months it does not add any more to the response he doesn't.
Reduce it so he stays the same but it does not add to it then of course, that's a very good indication to perform the interim analysis for the phase III trial.
At an earlier time point rather than to wait.
Without particular reason six more months, which adds a lot of problems through the trial and constant.
With that so that's the third thing that it would be interesting to understand from this design that compares three different time periods of exposure to the drug.
That's all there is to it now how this will translate to treating patients in clinical practice once youll have.
Drug available that's a different story.
And.
It will it will depend on other considerations such as the effect on clinical outcomes.
Most probably.
What everybody says today is that.
Treatment for Nash will have to be for a very long period of time. So it's not something that you will stop once you get a response.
But it is important to understand what was that in response to chris's earlier or later.
Order to have the patients.
The complaint and stick with the medication for the appropriate period of time.
Okay.
Alright Thats helpful. Thank you.
Our next question comes from the line of Justin Devon with BTG. Please proceed with your question.
Hi, Thanks for taking the question I'm just curious if you could help us put into context, how you view. This as a result of the fibrosis improvement.
As compared to some of the other datasets available in the are in the field currently.
So yeah.
I E.
As an academic I have to be very careful the way I answer your question because.
It is very hard to compare our studies between that are not head to head as you know.
And we can deploy in terms of duration of treatment in terms of population and so on and so forth.
The less.
For the moment.
Practically speaking there aren't many studies out there that had shown a clear effect on fibrosis progression.
Even drugs such as the GOP one receptor agonist to magnetite is very well known has not shown.
Pension to treat any effect on fibrosis Madrigal has not shown yet met their home has not shown yet convincingly that effect will be the results of the phase III trial.
But so and extends the only exception is actually oh vertical like asset over a period of time, an extended period of time of 72 weeks, but in a large phase III trial. So there aren't many examples out there of drug that were successful in reducing fibrosis.
So in that sense.
And I'm cold.
<unk> is positioned I think eh.
Particularly good.
Position here.
With the results that have been presented in the phase two b trial and the ones that I show you. Today, obviously it is not sufficient a phase III trial is necessary to prove beyond doubt that there isn't and fibrotic effects and this will be done hopefully with everybody's efforts, but.
But for the moment.
You simply consider the level of response in the patients I've shown you today.
And if you consider the historical placebo response rate you can see that the magnitude of effect.
Is higher than what has been shown.
With Oc eight are all other things.
<unk>, which are the fact that there is no direct comparison and this is not a placebo controlled trial, but even if this were a placebo controlled trial I don't think that especially with three pathologists.
The level of responsible placebo arm would be as high as 60% in Norway that what's happened.
So.
I think there's a clear difference here there there is something quite clear very difficult to compare with the other study is the only other thing you could compare it with otas because that's the only other positive trial in fibrosis.
And that comparison just between US goes you can say that.
In a scientific meeting in favor of the drug in the sense that the deep exercise versus placebo appears to be much higher but that's about as optimistic I can get given the design of this trial and the one from and the regenerate trial.
Great. Thanks, Mike.
Right sure.
It's very encouraging that because we're really new drugs that work on fibrosis.
And that is the appointment Oh, I mean the lately.
Lately based on the results reported so far is that actually very few drugs.
Have clearly shown an anti fibrotic effect. So it is very good news that we have some strong candidates.
Absolutely yeah.
And our next question is from the line of Steve seat House with Raymond James. Please proceed with your question.
Ryan Deschner on again for Steve to lead Us.
I wanted to ask.
Can you give us any more detail on Nash resolution or how the individual components, such as ballooning steatosis and the N equals 20 cohort compared to arrest and also what you're seeing in terms of weight loss across these cohorts. Thank you.
So then the other histological effects are being studied under way and we haven't.
Yeah.
Presented them, we did not stress. These results would not analyzed fully these results for the moment. So we kept that for the next scientific meeting because they'll be able to do this is particularly important so I cannot give you more detailed I gave you everything we had so far so there is nothing hidden here so.
You'll get you'll get all the information that has been rigorously analyzed.
On a on a cleaned up database.
You've got it all here so there's nothing else that can be shown so far but it will come stay tuned then I'm I'm sure that at each may each one of the two major meetings in the year you will have additional information and hopefully when we get to the 50 patients fully analyze histologically then we will get also older.
Details of the histological impact of the drug.
But for the moment, that's all we have so far.
Thank you and then in terms of weight loss.
In terms of weight loss of for the moment, there is no weight loss and use specifically by this drug. So we will see whether we the larger number of patients. There is a there is oh, there's a changing that but for the moment. There is no no clear effective weight neutral.
Got it. Thank you and then maybe one quick question. One last question. The proceeds three data from these cohorts.
It looks like it's definitely wide error bars, but it looks like its continuing possibly to improve from week 24 to 48.
That doesn't appear to be the case for for a L. P. S T chip for et cetera.
How are you taking this into account in terms of.
How are you looking at this in terms of.
Will you continue do you think that you'll continue to see proceeds III improve and what would the relationship theoretically be to further improvements in fibrosis.
Yeah.
Yeah Yeah.
Now how much we can over interpret that as you say the comprehensive gerbils arm, a whiter than for them in a transparent and so on it's still a biomarker that we are investigating all of US we were learning.
What it is worth and how it is.
The changes are in regards to two pharmacotherapy or other.
Our lifestyle changes so for the moment I would not I will not elaborate too much on a continuous reduction or obviously, it's good it doesn't.
<unk> after a week 24, so it's sort of reassuring.
I I'm I'm very prudent myself in terms of.
Interpreting the Biomarkers of fibrosis. So to me what will be a really important is as a first step to document the histological effect and then see whether the biomarkers sort of reflect those histological changes or not.
And if that is the case then we will use those biomarkers are based on that.
It would not today use them, primarily as an indication of the anti fibrotic effect, but rather as supporting evidence because we simply don't know enough about that plus there might be individual variability in how these particular biomarker response, which can be to some extent uncoupled from the individual variability to fibrosis.
So there are too many unknowns.
To be extra.
Extrapolating too much from this continuous reduction in proceeds, but obviously it is probably a good sign that it continues to drop.
What we'll see with larger number of patients. If this holds true.
Got it thank you.
And we have reached the end of the first question and answer session I will now turn the call back over to Anadarko to continue.
So thank you very much professor Russell and let me continue.
Right.
So obviously things are moving fast they've got them at giving the excitement and the energy in the company from the data we view the results we presented today a game changer for both the company and more importantly for the treatment of liver fibrosis.
Nonetheless, we view the skepticism regarding the NAS space over the last year.
As a result government makes enormous efforts in optimizing its enough program.
We focus on fibrosis improvement, which is the most important endpoints.
We increased the magnitude of the effect by over 50%, thus far by elevating the dose.
We employed a robust pathology reading process of three windows, but minimize the primary endpoint discrepancies.
And we designed a specific study to address the open question of ultimate optimal treatment duration.
The data we are presenting today reinforces three main effects.
One downregulation of Seb, one, resulting in significant improvement in liver fibrosis.
<unk> mechanism of action directly targeting collagen production and fibrosis is translated into the results we are seeing today.
60% of patients experienced one point or more in fibrosis improvement with only one patient experienced a worsening.
Ooh.
The hypothesis that a higher dose results, resulting significant clinical efficacy has been confirmed to date.
We have so far doubled our oncology fibrosis.
Ended up with a shorter and smaller conditional approval phase III study.
The data we are generating will allow us to have an evidence based discussions with the FDA on these points.
And three I'd say, it's corroborated by small and large cohorts.
The totality of the data at this point is highly encouraging for the next milestones.
With our open dialogue with the FDA based on our fast track designation, we look forward to continuing our updates as the study proceeds.
Now, let me transfer the call to our CFO the hushed insular.
Thank you Alan.
This morning, I will be providing you with our financial results for the third quarter ended September 32021.
For more information.
Voting for all fixed.
By literally yesterday with the SEC, which among other things provides a summary of such financial results.
For the third quarter of 2021, our net loss totaled $7 7 million or 71 per share.
Rather than a net loss of $6 9 million or <unk> 72 per share for the corresponding quarter in 2020.
Search and development expenses totaled $6 5 million for the third quarter of 2021, the same as for the growth for any quarter in 2020.
General and administrative expenses for the quarter totaled $1 3 million compared with $1 1 million, but a corresponding period in 2020.
Our cash balance as of September 37, 21, which includes cash cash equivalents.
Cash and marketable securities of $42 million 50.
51 million on December 31st 2020.
With that said operator, please provide instructions for a second Q&A portion of the call.
Operator.
But again, we will have our second Q&A session, if you'd like to ask a question you May press star one on your telephone keypad.
If you would like to remove the question you May press star two.
Our first question would be from the line of Ed Arce with H C. Wainwright. Please proceed with your question.
Hello again, everyone. This is Tom.
Thomas Yip asking a couple of questions for.
Our first question can you tell us when we should expect these double.
Double blind portion of farmer to begin enrollment in Europe.
I'll discuss.
Separations for manufacturing of their new around core macro vein formulation for a clinical trial.
Thank you Tomas so.
We've previously announced we are planning to Reinitiate the double blind part of the study in the second half of next year of 2022.
There is no need infectious the menu protocol, because the existing protocols allow us to shift from the.
Open label part with a double blind spot without the need for a protocol update.
We'll do that.
When.
We will have sufficient data to discuss with the FDA the new design that we're anticipating.
Which.
We believe will be shorter.
Remind me at the moment the design of the double Blind 40, 72 weeks I can almost certainly tell you that at this stage.
We believe this is going to be shorter.
Discussed with FDA, how 40, it will meet and say.
Same is the FX side clearly the design. The initial design was based on the phase II study on the arrest study we've doubled the effect on fibrosis and the fixed side have changed and we need to discuss with FDA the nu.
The number of patients that will be required for a significant P value.
We are continuing in full force with the manufacturing of our <unk> Meglumine.
Clinical batches, we are preparing for beginning of next year. The bioequivalence studies between our Unquoted twice daily the PID the current JV and our encore Meglumine regulatory Bioequivalence study and once these are done and confirmed.
Can initiate the double blind study.
Okay got it.
Perhaps follow up on the West should we see the corporate.
We're going to stay there.
Oh, yes.
Sure.
I thought the second half of 2022.
Randomize portion begins.
So that will be in parallel I mean these are the same clinical batches that will be used we are working with the clinical batches that.
First of course, we'll have to demonstrate bioequivalence and then we can move to.
The double blind.
But we are preparing the manufacturing and.
Packaging supplying et cetera of the.
Drugs for the second part.
Well they look for the double blind part.
Right, Okay got it.
One final question.
Where should we.
To see the next update for general partner.
How are you guys.
Our progress for our uncle.
So here we are struggling between those two forces.
Have the scientific conferences.
Conferences.
Nustar Hep Dart is though we are presenting we just presented.
The data recently in the fibrosis.
So we are have to juggle between the financial community in the scientific community and we will do our utmost.
To satisfy both so we are restricted with embargoed data and Bob Gulf Coast by scientific committees that we would like very much to have the data presented there and at the same time, we try to synchronize that and we did this time with the.
<unk>, so around Ethan I would expect around easily.
We would.
We will release another set of data.
Okay understood. Thank you again for taking my questions and we look forward to a very exciting upcoming 12 months.
Thank you for joining our call.
Our next question comes from the line of Christian Cuzco with Canaccord. Please proceed with your question.
Hello. This is Rick on again for Kristin Congrats on the data again, and we like to look at the new <unk> website.
One thing in particular, you've always emphasized is the greater attention you've taken care of individuals sites and the number of countries you are enrolling in even despite looking at the speed of the U S trial site enrollments. So we wanted to ask based off this recent nature medicine publication, if you could speak to the diversity of this.
Patient population and any key findings observed there.
Okay. So so we still envisage very much that the the population for the double blind spot would be about 50% would come from the U S and the rest would come from the rest of the world and with that said is we have of course, Europe and Latin America, and we have Korea and we have.
China, and we have Australia.
So.
We have not changed the demographics that because.
Different.
Yes.
We're looking at potentially different partnering deals with different in different geographical areas and we need to satisfy.
The number of patients which are needed for approval in every single jurisdiction.
So this has not changed we are working with a selected number of sky.
In the U S.
Have fun with.
With a group called <unk>.
<unk>.
The majority of the U S patient comes from old you have together of course with the leading universities that usually participates in in Nash studies.
Central Europe Europe, we have now.
London, and France, and Germany, and Italy, and Spain, and Belgium et cetera.
So all of the leading.
University type that you would find in other Nash studies are also participating and will participate in the double blind part.
Okay, and maybe just one more quick one.
Could you please discuss the phase one data readout for myelofibrosis.
And perhaps how youre thinking about gating steps and initiating a phase <unk> proof of concept study.
So we are in the process of finalizing the.
The data.
The in life has been completed the effect of the three phases. There is one additional phase that we've added.
So we are really the process. This is not public information yet so we cannot give any any data.
But we are proceeding as you alluded to.
Quickly embark into <unk> and potentially through a study early next year.
Okay. Thank you very much.
Okay.
Thank you Eric.
And our next question comes from the line of Steve <unk>.
At Raymond James. Please proceed with your question.
Okay.
Hi, This is Ryan Deschner again on for Steve <unk>.
<unk>.
In the recent dataset the ALC reduction looks like it could be a little more pronounced in equals 20 cohort are you seeing a correlation between <unk> reduction and baseline IOP, New York fibrosis stage.
And can you tell us what the baseline IOP levels for the N equals 20, and full archon cohorts.
Thank you.
So professor Russ you alluded we've presented all the data that we have we did not run any correlation or any any other.
Analysis apart from the ones that we've provided.
Okay.
Okay got it thank you.
Okay.
And we have reached the end of our question and answer session I will now.
We will now turn the call back over to Alan <unk> for closing remarks.
So thank you all for joining our conference call today and thank you again for professor Roxio for your presentation.
Today's presentation will be uploaded on our website under the events and presentations section and you'll have a great opportunity also to view, our new website, which are very soon will include also additional links to the almost study.
And as always we welcome.
Any question that comes during the quarter you can.
Communicate directly.
To me or to anyone else in the team and we're very happy to correspond. Thank you very much and have a nice day.
This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.
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