Yale Jen: Good afternoon, and thanks for taking the questions. I came in late, so maybe if you can reiterate a little bit in terms of EFZO-FIT enrollment. I know the press release indicated it’s on track was there any other color of that? Then I have another question.
Sanjay Shukla: No, Yale very much on track. Very much feeling good. You know, about Q2 this year, so very much on track.
Yale Jen: Okay, great, that’s good. And you mentioned a few preclinical programs and they look very interesting at this juncture. Was those the programs you intend to partner out at some point, or what will be the path you are thinking about moving forward with those preclinical programs?
Sanjay Shukla: Well, I think it’s, I mean, for everything as a biotech, like kind of where we are, you always have to look at partnering and those sorts of opportunities. If there’s no shortage of interest, obviously we have a rather novel platform here, and the platform now is generating more and more validated opportunities. So that will be something that we’ll look at. We always look at these sort of potential arrangements. At the same time, we also are potentially, sitting on assets here that really are producing signals really never seen before. When you talk about being able to induce apoptosis of myofibroblasts, I don’t think you’ll hear too many companies really seeing those kinds of early signals. So that’s where this biology, I think, it’s important for everyone to understand.
There’s hidden potential here, there’s hidden potential efficacy here. And I think what aTyr is doing is really looking at these genetic codes and saying, where can they best be applied where there is disease and dysfunction. Well? So unlike, you know, generations of MeToo therapies that have been out there that are not disease modifying, I think all of our approaches, Efzofitimod and even some of the pipeline approaches we have here are, we have a very, very high bar here. They have to be disease modifying, they have to really be showing activity here that is two standard deviations better than most– opportunities out there. And I think we want to be careful about– giving away these gems too early, but we’re open to talk to big players at all times.
Yale Jen: Okay, great. Maybe just speaking one more question here, which is that, as you said, the trial is on track to complete enrollment second quarter. And just curious, in terms of the current in Japan, given they have smaller size, have they already completed any colors on that? And thanks.
Sanjay Shukla: Yeah, I can’t really get into who’s completed it. I mean, it more or less is competitive enrollment. There aren’t hard caps per se, country by country. We have our goals on what we want, where we want to get to. So I wouldn’t think of it as a separate trial. We’ve said in the past that a region like Japan, you might expect 25 to 30 patients there. So Japan, like the rest of the world that we’re working in right now, very much on track, you know, to meet our projections to get this trial wrapped up here in Q2, at least enrollment.
Operator: [Operator Instructions]. Our next question comes from Robert LeBoyer with NOBLE Capital Markets. You may proceed.
Robert LeBoyer: Good afternoon and congratulations on all the progress. I also have a question on the expanded access program and was wondering whether you’re going to be compiling endpoints and other data that can be used in the BLA or whether you can present some of the extension some of the extension study data at medical meetings either before the data is announced or afterwards.
Sanjay Shukla: Yeah, it’s a great question, Robert. So just want to highlight one thing here is this is being conducted outside of our protocol and that’s being done for a few reasons. Number one, we want to hit our BLA timelines and submit, finish the primary trial, if you will, the primary portion of the trial and submit that. This secondary piece of the trial is sitting outside of our protocol. Why are we doing it that way? Well, first of all, health authorities didn’t mandate that we do any kind of open label extension. There was no known safety risks observed early in the program, in our last program. And we had long-term safety data already from this trial. So there was really no need to have a more formal open label extension or anything like that.
So this trial will be done outside of the boundaries of our protocol. Now, already I would say many academics are really interested in looking at patients 18, 24 months out, perhaps with or without efzofitimod long-term. So I can’t say that there would not be an academic consortium of some of our experts that would want to put out this data. I would support that. I think they could look at different things that within the confines of our own protocol, we haven’t been able to look at– to look at long-term, you know, steroid reduction effects. Some of the early promising things we see with regards to things like weight loss,– it was always theoretical. You get off steroids, you could help with weight. You know, we’re seeing some– rather remarkable signals there it’s early, it’s anecdotal.
This might be something that we could look at, those investigators could look at in some sort of academic survey. They may want to look at some sort of imaging data two or three years later. But right now we’re focused on getting this drug approved, getting the BLA out. Those trickle of that kind of interesting data could almost be a headstart to Phase 4. That’s the way I look at it. We also don’t want to spend money on that sort of– downstream side of the fence right now. But I think there’s going to be some intriguing potential there to collect data, not only for the patients that continue in the trial, but also those that might have to revert back to steroids and see what happens with those patients. But I think it’s a great question, Robert.
