Altimmune says pemvidutide given ‘clean safety bill of health’ by FDA

At the Guggenheim Securities Healthcare Innovation Conference, Altimunne said earlier: “So the first thing is that survodutide has a ratio of GLP-1/glucagon of 8 to 1. It’s much more heavily biased to GLP one, we’re 1 to 1, which means that we have more glucagon potency. So if you believe in glucagon and its effects on liver fat and lipids, we’re a preferred molecule. We actually beat Survodutide on their weight loss at 48 weeks, given the same statistical analysis. And in addition, we’re much better tolerated there. Adverse event discontinuations were in excess of 20% or all of their doses approaching 30%. In fact, that one study presented at the liver meetings 47% adverse event discontinuation rates, and now they’re announcing titration out to 24 to 32 weeks, whereas we can achieve better than that with a much more limited dose titration. I think it’s also important to realize that we were given a safety bill, clean safety bill of health by the FDA. If you look at the Survodutide Phase three program, we actually have a safety study in there that’s powered to show non-inferiority to placebo. Sorry for the statistical terms to show no harm greater than placebo, and that’s very unusual… So that’s a bit strange. It hasn’t been enforced in any of the other sponsors. They mentioned in a recent publication that glucagon could have cardiotoxic effects So this is a reasonable study to do. We’re speculating that there might be something there that raised the attention of the agency. We don’t know for certain. But I would say flipping back to Pemvidutide is that we were given a very good clean a very clean bill of health by the agency. As we mentioned before our studies are all efficacy studies. They’re not safety studies. We weren’t asked to do one by the agency.” Survodutide is a drug being developed by Boehringer Ingelheim to treat obesity and metabolic dysfunction-associated steatohepatitis, or MASH.