Altimmune, Inc. (NASDAQ:ALT) Q4 2022 Earnings Call Transcript

We’re not committed, by the way, to use the titration going forward. We’ll look at the data, we may drop it. We’d point out that we’re the only drug in development for either obesity or NASH that’s incretin-based that can actually dose without dose titration. We have the optionality if we want, and this is not something that we’re doing right now but something that we’re quite aware of, if we ever got back research for example, market research which we’re conducting continuously, that patients preferred the tolerability over the titration, we could offer titration as an adjunct either in a late stage trial or as a separate user trial, and actually offer that to patients and doctors as a prescribing option. That’s something that the other drugs in development, like tirzepatide and semaglutide, can’t do because they’re already at four to five months of titration and the question is, how much longer do they need to go.

We think that the titration, based on what we’ve seen before, is helping, but is it needed? We don’t know. Will it affect the efficacy at 24 weeks? We don’t believe it will, and certainly not at 48.

Corinne Jenkins: Helpful, and then just a point of clarification for me, with the weight loss–sorry, with the diabetes study that’s coming soon, will you share weight loss data from that trial or is it going to be primarily focused on the diabetes-related end points?

Scott Harris: Right, no, we will share that data. We’ll also share the information on the diabetes end points.

Corinne Jenkins: Thanks.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Mayank Mamtani from B. Riley.

Mayank Mamtani: Good morning team, thanks for taking our questions, and congrats on the progress. On the Phase IIb NASH study design, I know you’re not commenting on the total number of subjects yet, but just curious if your interim 24-week readout will be like the Phase IIb MOMENTUM readout, where you’ll include sort of a smaller cohort of patients for that 24-week biopsy, or would you have the full population? Just trying to see how much excitement there is out there for enrolling for your NASH study, like we saw with the obesity study.

Scott Harris: Thanks for the question, Mayank. You know, that readout that would occur in the first half of 2025 would not be an interim analysis, that would be a full readout because it’s a readout on the primary end point at the established time point for reading it out. Now, we may elect to continue following patients, but the efficacy of the study with regards to the primary end point would already be established. When we read out in the first half of 2025, it will be in the entire study population, and that’s in contrast to the readout that we’re going to have in the latter part of March, where we’re actually doing a cut of the patients, approximately 160 or approximately 100–about 50% of the patients and only at about half of therapy, so the readout in the first half of 2025 in that NASH trial will be a complete readout.

Mayank Mamtani: Got it, thank you for that clarification. Then on MOMENTUM, it seems like the focus here is on totality of data, rather than any one specific metric, better weight loss. Are you willing to comment on what your expectation might be on maybe the discontinuation rate for pemv versus placebo, and also I think a similar comment, if you could have on the hyperglycemia study that you’re running in parallel to MOMENTUM. I know the follow-up there is shorter there, 12 weeks. I have one final question after that.