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

Our hope is that we would be meaningfully above the other drugs when we look at the trial at 48 weeks.

Jon Wolleben: That’s helpful. Just one on the NASH study, I know you’re in the finalization steps with the design, but how are you thinking about dosing? The 1.8 milligram dose seems to be the most effective so far. Is it worth moving forward to 2.4, or is the 1.8 probably the sweet spot? Just wondering how you’re thinking about that. Thanks.

Scott Harris: Well, that’s a question that’s on our mind, and the decision is going to be data driven. Obviously we’ll make decisions about the NASH trial based on what we see in MOMENTUM, whether we carry the 2.4 milligram dose forward. You know, although we haven’t seen any convincing data that 2.4 is better than 1.8, we do know at least from the obesity point of view with semaglutide, that when they got to super obesity, which you would define as 110 or 115 kilograms, that serum concentrations dropped and with that, there was reduction in the percentage weight loss that patients achieved. Now, that wasn’t seen with tirzepatide. Then the question is, will we as a compound behave more like semaglutide or tirzepatide, and at this point we’ve modeled out the data but we’re not absolutely certain, so we’ve used the 2.4 milligram dose essentially as an insurance policy in case we also see that effect.

That strategy might be more relevant to obesity than NASH. We are modeling the data. There are systems and modeling efforts that you use, among them things like population PK, so we’ll use that information that we’re developing in-house with MOMENTUM data to make a decision about the doses going forward. That in many ways will drive the sample size, which was one of the earlier questions. If we have multiple arms in the study, including 2.4, that would require more patients to achieve adequate power. If we’re not going to do 2.4, the study would be smaller and we could get it done more quickly, and that’s what’s being considered right now, which is why we’re not making an announcement about the design or the numbers. We want to see the results of the MOMENTUM trial, finish our modeling, and then we’ll come up with a conclusion, and as soon as we have that, we’ll share that conclusion and the design of the trial with the street.

Jon Wolleben: Very helpful color, thanks Scott.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Patrick Trucchio from HC Wainwright.

Joe Pantginis: Hi, this is Joe on for Patrick. Thank you for taking the question. Switching gears a little bit to the HepTcell Phase II, just wondering from the initial readout following the six months on treatment, in terms of both clearance and hep-B surface antigen and seroconversion, how important is it that patients also achieve seroconversion at six months?

Vipin Garg: Dr. Roberts, do you want to take that?

Scot Roberts: Sure. I think that obviously that’s a nice to have. I think really what we’re looking for is the ability to reduce the surface antigen, and this is still a relatively short trial even at six months of treatment, and so seroconversion is certainly being followed, is certainly of interest. But I think that significant reductions in the surface antigen, we set the bar at a one log reduction is really what we’re looking for. Again, the purpose of this trial is to establish that HepTcell has, as a monotherapy, activity against chronic hepatitis B. It’s viewed that the effective treatment of the disease will require combination therapy, and so we’re using this patient population that already is partially controlled, like they might present having received some of the new direct acting antivirals, and then the immunotherapeutic, like HepTcell being able to drive that clearance of the surface antigen with the presumption of seroconversion.