Mark Eisner: Yes. And just briefly, in terms of the client results, you had alluded to the week 24 results. So just a couple of points. I mean, first of all, they’re early in development. We’ve seen the Phase 2a data, which are at 12 weeks. So whether that can extrapolate to 24 weeks or more importantly, 48 to 52 weeks, which will be required for approval is a question, the sort of longer-term safety remains a question. And of course, the efficacy beyond 12 weeks, those will be questions as well as the dose response and how is that holding up? So a lot of questions there still we’ll be watching as you are for the week 24 results. But even with that, there’s still going to be a lot more to be answered in later-stage clinical trials.
Jason Gerberry: Got it. Thanks, guys.
Operator: Thank you. Our next question comes from the line of Andy Hsieh of William Blair. Your line is open, Andy.
Andy Hsieh: Great. Thanks for taking my questions. Maybe we can start with LELANTOS-1. I know it’s like a one-year trial, but I’m just curious in terms of the non-ambulatory patient disease progression in terms of patients succumbing to the disease, how long does it take if you want to see that signal in terms of OS separation do you need? And are there any signs that based on real-world experience, they can start to see something like that?
Mark Eisner: Right. So thanks for the question. I think you’re asking about in the non-ambulatory population of LELANTOS-1, whether we would expect to be powered for overall survival or mortality signal. I think that would be challenging. I mean it’s a study of slightly less than 100 patients. We are looking at performance of the upper limb as a primary endpoint. We’ll also be looking at forced vital capacity, percent predicted in other secondary endpoints that can reflect the overall disease progression, I think overall survival would be a challenge, although it’s certainly something we will be tracking.
Andy Hsieh: And related to client, in one of their Q&A, I believe, they mentioned about filing based on one study or the potential of doing something like that. And so that challenges the conventional wisdom at least regarding the regulatory pathway of IPF. I’m just curious from your interaction with the FDA, do you see kind of a shift in terms of the agency’s stance? And would that kind of open up if data supports to file on one.
Mark Eisner: Good question about the filing strategy. And I would bring it back to our program, in particular, and what we said before and what we continue to believe is that if it will be data dependent and FDA feedback dependent about whether we can file ZEPHYRUS-1 before the results of ZEPHYRUS-2. In particular, we’d be looking for highly clinically and statistically meaningful results on the primary endpoint, secondary endpoints and also a very good benefit risk profile in terms of safety and how that all plays in. If we see those kinds of findings, we will, of course, be discussing that with the FDA about whether we could file based on the single trial or whether we need to base that on both trials for filing. In terms of the broader regulatory landscape, I do think this continues to evolve.
If the precedent is still has been two trials. But I think this will be dependent on the data, in our case, that we generate and the feedback from the FDA. Yes, it is worth noting — It’s worth noting my colleague than reminds me that both Roche and BI have one trial in IPF as indicated by their ct.gov costings.
Andy Hsieh: Right sorry. Right, exactly. Got it. Maybe just one quick question. Could you remind us for the IPF studies, do you have incorporated like an interim efficacy look?
Mark Eisner: No interim efficacy evaluations, no.
Andy Hsieh: Got it. Okay. That’s helpful. Thank you so much for answering all of our questions.
Operator: Thank you. Our next question comes from the line of Danielle Brill of Raymond James. Your line is open, Danielle.
