Annabel Samimy: Hi, thanks for taking my question. And the tremendous amount of details that you’ve provided for the Phase 2. I guess I want to look a little bit bigger picture. When we think about the Phase 2 trials that you’re conducting is the intention to potentially make lanifibranor available to all patients you trying to gear it towards a type 2 diabetic patient, which it seems to have some tremendous benefit for and then also on the LEGEND trial. So you’re looking at it in combination with , but it seems that a number of these patients or a number of the physicians believe that these patients will already be on some kind of background with one. So I’m just wondering, again, bigger picture, how do you envision some of these combinations to play out in real world?
And are you intending to try to find another combination treatment to optimize lani? Or is it to €“ that’s maybe oral and more suitable for the population that you’re targeting? Or is it just too potentially manage some of the weight gain issues or whatever optimize its profile in general? So I guess, I’m trying to understand how it works out with the GLP-1 as well as the combination trials that you’re looking at right now. Thanks.
Frédéric Cren: Okay. So maybe on the Phase 3 for currently, of course, we have patient F2, F3 and we stratify for patient with NASH and type 2 diabetes. Clearly, our intention and our belief that lani addresses both population. So €“ and that has been shown in the Phase 2b, it’s effective in patient with NASH and it’s also effective in patient with NASH and type 2 diabetes. Where and why we work a lot on the anti-diabetic properties of lani is because we look at competition. And when you look at competitors, we believe we are the only one that have this direct insulin sensitizer properties. And so if you position yourself from the patient perspective and you have NASH and type 2 diabetes, if you’re treated with lani, not only you would improve NASH, reduce your fibrosis, but on top of that, you would €“ lani would help further control your HbA1c.
So it’s really a perfect drug for this patient. And we also established that when we look at patient with pre-diabetes treated with lani during the Phase 2b, those patient during the course of the trial had seen their diabetes stop progression. So clearly, it’s a patient population that we like. And then ultimately, when we talk to endocrinologists, we realize that they have huge amount of patients that are sitting in their offices that have NASH. And so developing and producing the type of data, we’ll generating for his Professor Cusi, I think will help position the drug among endocrinologists. Now, maybe for the GLP-1, I let Michael or Pierre answer. Just one comment just to point out that in the current NATiV3, the Phase 3, we are allowing patient under GLP-1, under a stable dose of GLP-1 for three months.
And so we are including patient with GLP-1 in the trial. And that will help us of course generate data about combining lani and GLP-1. Maybe Michael or Pierre, do you want to add something about LEGEND and combination with GLP-1?
Michael Cooreman: Yes. So I think the €“ in these diseases, it’s also non-cardiovascular disease and diabetes treatment paradigms changes, new treatments become available, and semaglutide specifically or GLP-1 receptor agonists certainly have or changing that paradigm. And now that GLP-1 receptor agonists are becoming €“ have become first line treatment in type 2 diabetes. So I think that’s something that we adapt to. I don’t think €“ I think that’s actually an opportunity. I mean, we will €“ we do allow patients who are on a stable dose to be enrolled in NATiV3. We may also, since Frédéric refer to that, consider to get use that opportunity to update LEGEND if you wish. And that’s something that we are discussing.
But I think lanifibranor remains a very distinct drug from the other compounds in that it has pan-PPAR agonist, it does have this effect on metabolism as well as on inflammation as well as on the fibrosis. And so for disease like NASH and type 2 diabetes that go hand in hand or approval will be for NASH, but many patients will have type 2 diabetes. And even those who don’t have over type 2 diabetes, many of those are €“ have pre-diabetes, which the diabetology community also recommends to treat. So this is an advantage I think that we have in the NASH field. And the €“ in fact that the treatment field for type 2 diabetes is changing something that we use to our advantage to position lanifibranor in combination with these newer treatments as well.
So I think that’s how our studies are currently designed. And I think that lanifibranor will have an attractive position in this field.
Annabel Samimy: Okay. Great. Thank you.
Operator: We’re now going to proceed with our next question. The questions come from the line of Ed Arce from H.C. Wainwright. Please ask your question.
Ed Arce: Great. Thanks for taking my questions and congrats on the continued progress. A few for me. Firstly, just wanted to ask if you can disclose how many patients are currently enrolled in NATiV3. And then turning to the outcomes trial, I think you mentioned 900 patients is the total target, but I think there’s 800 on the slide, just wanted to confirm the total number there. And then lastly, also with outcomes, which dose of lani are you planning to use for that trial? And then I have a couple of follow-ups.
Frédéric Cren: Okay. So let’s take the first two. I think on the outcome trial, disclose number of patient that we have randomized and enroll, we have not of course we monitor the situation daily, and we’re very pleased with the enrollment, with the screen failure I mentioned. We have, let’s say battled or anyway had to concentrate improving the screen failure, which was earlier than what we expected. That is something that is general in the industry, but we’ve been really working out and we see the screen failure going down for the past €“ regularly for the past several months. So that’s very positive. As I mentioned, we have quite a large number of sites that are screening €“ and actively screening, so we €“ that gives us confident that we can meet our target of end of enrollment for the second half of this year. Then on the third question, on the dose may maybe Michael, you want to give highlight of the discussion we’ve had with FDA?
Michael Cooreman: Yes. If I understand the question correctly, correct me if I’m wrong it was about the total number of patients that we enrolled in the outcome study. So our estimate is 800 €“ about 800 with two arms, one dose of lanifibranor and placebo. And the 950 or 960 is for the NATiV3. The study that you are currently running that is providing the data for accelerated approval. So, did I answer your question right?
Ed Arce: Actually, Michael the question €“ the other part of the question was which dose would you be using, intend to use for the outcomes study? Which dose of lan?
Michael Cooreman: No. We have not decided yet. But we will choose one dose. I think when we finalize the design we’ll take all information into consideration, which includes the clinical pharmacology data, but also the data that we get from NATiV3 depending on where we are.
