Altimmune, Inc. (NASDAQ:ALT) Q3 2023 Earnings Call Transcript

So we see those doses moving forward. As you mentioned, there was a higher than we expected adverse event discontinuation rate at the 2.4 milligram dose. But as you pointed out, it was the same if not less in the adverse event discontinuations that have been seen in other Phase 2 programs like the semaglutide program in tirzepatide Phase 2 programs, and that they made the necessary adjustments going into Phase 3 to get their adverse events down towards where they are right now in the single digits. We have a lot of opportunity to do that. We have, as you said, we could modify dose titration, but a very important difference from the other trials is that we did not allow dose reduction. And as I mentioned before, in the tirzepatide and semaglutide trials, as much as 30% of those patients either never got up to the highest dose or dose reduce once they got there.

And consequently, you can see that by putting a dose reduction scheme or more flexibility in the up titration in our study, our studies, we really think that we can get that adverse event rate down even without having to dose titrate any further than we are right now. Vipin, would you like to answer the second question about the partnership?

Vipin Garg: Yeah. Thanks, Scott. So Roger, as we have said before, obviously, this 48-week data is very fast moving our partnership discussions forward with we’ve already received with people discussing out there, and our goal is to be Phase 3 ready by the second half of next year, and that gives us enough time, plenty of time to also line up a partner to initiate that Phase 3 program. So that’s really what we are executing to, we feel that with the data that we are expecting at 48-week read out that would give us the best opportunity to line up a partner to move forward into Phase 3.

Roger Song: Excellent. Thank you. That’s it from us.

Operator: Thank you. And our next question coming from the line of Mayank Mamtani from B. Riley. Your line is open.

William Wood: Hi. This is William Wood on for Mayank today. Congratulations on the — on your quarter. So, a couple of questions from us. Thinking about your upcoming Phase 2 momentum top line readout, are there any data sets that you’ve recently prioritized and decided to include possibly body composition or lean muscle?

Vipin Garg: Yes. William, the readout that we’re going to have this quarter will be, in many ways, similar to the parameters that we read out before 24 weeks. So let me repeat that. It will include body weight loss to include waist circumference. It will include serum lipids. It will include a readout on vital science, which we think are very important and differentiating. And will include glycemia control and also report on adverse events within data included on the discontinuations. We also expect to have data on reduction in liver fat. We are doing body composition measurements to this trial. At this point, we do not think that we’re going to have them for the top line results, because they require more analysis than just liver fat analysis. So that additional readout on, say, lean body mass will probably come sometime after the top line results.

William Wood: Got it. And then you mentioned and you’ve previously reported that you have a presentation coming up at AASLD this weekend or early next week. You mentioned, it’s just going to be new data on anti-inflammatory and anti-fibrotic properties of pemvi. Do you think you could go into a little bit more color on what we may expect to see and how we should view that data speeding into the FDA decision granting you FTD and then obviously, your IMPACT trial?

Vipin Garg: Thank you, William. I cannot discuss the data in that poster, because it’s embargoed by AASLD roles as late-breaking abstracts. But as you can see, the FDA saw all of the data, including the data that — the additional data that we’ll present. Additional data on not only anti-inflammatory properties of pemvidutide but even more importantly, the anti-fibrotic properties of pemvidutide, and they are aware of all that when they saw the Fast Track application and granted that designation to Altimmune. We believe that pemvidutide with its very high reduction in liver fat content and class-leading effects on anti-inflammatory markers will result in important improvements of fibrosis and the abstract will highlight the observations that we’ve made to-date on the latter point.