Altimmune (NASDAQ: ALT) has announced positive topline results from the IMPACT Phase 2b trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks.
According to Altimmune, topline 48-week data from the IMPACT trial showed that treatment with pemvidutide achieved statistically significant improvements across treatment arms in key non-invasive tests, including enhanced liver fibrosis (ELF) and liver stiffness measurement (LSM),
versus placebo.
In a statement, Mazen Noureddin, MD, IMPACT trial principal investigator, professor of medicine at Houston Methodist Hospital and co-chairman of the board for Summit and Pinnacle Clinical Research, commented, “The magnitude of response versus placebo on measures such as ELF and LSM at 48 weeks makes these data particularly compelling, as these noninvasive markers have been shown to correlate with histologic fibrosis stage. These results reinforce that pemvidutide may address both liver-specific and metabolic drivers of MASH without compromising tolerability—three critical elements of a potential effective treatment for this patient population. I am encouraged by the dose response observed and the performance of the 1.8 mg arm and I am eager to see this differentiated therapeutic candidate advance into Phase 3 evaluation.”
Additionally, the company announced that it held a productive End-of-Phase 2 meeting with the FDA, which resulted in alignment on the parameters for a registrational Phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis.
