Altimmune Expands Weight-Loss Drug Pemvidutide's Potential To Alcohol-Related Disorders

Altimmune Inc ALT hosted a virtual R&D day on Thursday, marking the first disclosure of Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) as potential developments for pemvidutide.

Phase 2 trials for pemvidutide in AUD and ALD are expected to start in the second and third quarters of 2025, respectively.

Altimmune anticipates pemvidutide will reduce alcohol cravings, improve liver health and promote weight loss.

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• The primary endpoint for the Phase 2 ALD study will be a change in liver stiffness measurement at 24 weeks, with other key endpoints of weight loss and change in alcohol consumption, with an additional reading at 48 weeks.
• The primary endpoint of the Phase 2 AUD study will be the change in the number of heavy drinking days at 24 weeks and the change in biomarkers of alcohol consumption and weight loss as secondary endpoints.

William Blair writes, “In our view, AUD and ALD are logical extensions for evaluation of pemvidutide’s efficacy, given its mechanisms of action.”

Altimmune shared the MOMENTUM Phase 2 trial data summary during the presentation, showing that over 30% of subjects lost ≥ 20% of body weight on pemvidutide 2.4 mg dose.

• The lean mass ratio of lean body mass weight loss to total weight loss was 21.9% for pemvidutide in the Phase 2 MOMENTUM study, compared to 39.9% for semaglutide (based on Phase 3 STEP-1 trial data), 37.7% for retatrutide (from the Phase 2 study), and 26% for tirzepatide in the Phase 3 SURMOUNT 1 trial.

Novo Nordisk A/S’s NVO semaglutide is available as Wegovy and Ozempic and Eli Lilly And Co.’s LLY is available as Zepbound and Mounjaro.

The company says Phase 2b IMPACT trial results of pemvidutide for MASH are expected in the second quarter, and if successful, pemvidutide would become:

• The first incretin-based agent to achieve statistical significance on fibrosis improvement at 24 weeks.
• The first therapeutic candidate in any class to achieve statistically significant fibrosis improvement and meaningful weight loss at 24 weeks.
• Altimmune expects to start registrational Phase 3 study in MASH in the first half of 2026

The presentation highlighted that at 24 weeks in the Phase 1b trial in metabolic dysfunction-associated steatotic liver disease (MASLD), pemvidutide demonstrated a 76.4% relative reduction in liver fat at the highest 2.4 mg dose (compared to 14% for placebo).

ALT Price Action: ALT stock is up 4.71% at $5.45 at publication Friday.

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