Altimmune Inc ALT hosted a digital R&D day on Thursday, marking the primary disclosure of Alcohol Use Dysfunction (AUD) and Alcohol Liver Illness (ALD) as potential developments for pemvidutide.
Section 2 trials for pemvidutide in AUD and ALD are anticipated to begin within the second and third quarters of 2025, respectively.
Altimmune anticipates pemvidutide will scale back alcohol cravings, enhance liver well being and promote weight reduction.
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- The first endpoint for the Section 2 ALD examine can be a change in liver stiffness measurement at 24 weeks, with different key endpoints of weight reduction and alter in alcohol consumption, with an extra studying at 48 weeks.
- The first endpoint of the Section 2 AUD examine would be the change within the variety of heavy ingesting days at 24 weeks and the change in biomarkers of alcohol consumption and weight reduction as secondary endpoints.
William Blair writes, “In our view, AUD and ALD are logical extensions for analysis of pemvidutide’s efficacy, given its mechanisms of motion.”
Altimmune shared the MOMENTUM Section 2 trial knowledge abstract throughout the presentation, displaying that over 30% of topics misplaced ≥ 20% of physique weight on pemvidutide 2.4 mg dose.
- The lean mass ratio of lean physique mass weight reduction to whole weight reduction was 21.9% for pemvidutide within the Section 2 MOMENTUM examine, in comparison with 39.9% for semaglutide (primarily based on Section 3 STEP-1 trial knowledge), 37.7% for retatrutide (from the Section 2 examine), and 26% for tirzepatide within the Section 3 SURMOUNT 1 trial.
Novo Nordisk A/S’s NVO semaglutide is offered as Wegovy and Ozempic and Eli Lilly And Co.’s LLY is offered as Zepbound and Mounjaro.
The corporate says Section 2b IMPACT trial outcomes of pemvidutide for MASH are anticipated within the second quarter, and if profitable, pemvidutide would turn into:
- The primary incretin-based agent to attain statistical significance on fibrosis enchancment at 24 weeks.
- The primary therapeutic candidate in any class to attain statistically vital fibrosis enchancment and significant weight reduction at 24 weeks.
- Altimmune expects to begin registrational Section 3 examine in MASH within the first half of 2026
The presentation highlighted that at 24 weeks within the Section 1b trial in metabolic dysfunction-associated steatotic liver illness (MASLD), pemvidutide demonstrated a 76.4% relative discount in liver fats on the highest 2.4 mg dose (in comparison with 14% for placebo).
ALT Worth Motion: ALT inventory is up 4.71% at $5.45 at publication Friday.
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