Altimmune(US:ALT)2025-12-19 14:02Summary of Altimmune Conference Call Company and Industry - Company: Altimmune - Industry: Pharmaceutical/Biotechnology, specifically focusing on liver diseases such as MASH (Metabolic Associated Steatotic Liver Disease) Key Points and Arguments 1. IMPACT Phase 2b Trial Results: The 48-week data from the IMPACT trial of Pembidutide in MASH showed significant improvements in non-invasive markers of fibrosis, with continued reductions from the 24-week time point [4][21] 2. Weight Loss: The 1.8-milligram dose of Pembidutide resulted in additional weight loss from 24 to 48 weeks, with no evidence of plateauing [4][21] 3. FDA Engagement: Altimmune had a productive end-of-phase 2 meeting with the FDA, aligning on the registration of the phase 3 program for MASH patients with moderate to advanced fibrosis [17][18] 4. Tolerability Profile: Pembidutide demonstrated a favorable tolerability profile, critical for maintaining patients on therapy, especially in a chronic disease setting like MASH [15][16] 5. Dose Response: The data indicated a clear dose response, supporting the focus on the 1.8-milligram dose for phase 3 trials, with potential for a 2.4-milligram maintenance dose [8][15] 6. Comparison with Other Therapies: Pembidutide's improvements in ELF and liver stiffness measurements were favorable compared to currently approved therapies like Resmetirom and Semaglutide [12][13] 7. Safety Profile: No serious adverse events were reported, and the majority of adverse events were mild to moderate, with good glycemic control maintained in diabetic patients [15][16] 8. Regulatory Strategy: The primary endpoint for the phase 3 trial will be biopsy-driven, but there is potential for incorporating non-invasive tests (NITs) as the FDA's stance evolves [42][43] 9. Sample Size for Phase 3: The expected sample size for the phase 3 trial is between 1,000 to 1,500 patients, with discussions ongoing with the FDA [40][41] 10. Future Plans: Altimmune plans to initiate the phase 3 MASH trial in 2026, with additional trials for other indications like AUD (Alcohol Use Disorder) and ALD (Alcoholic Liver Disease) [20][21] Other Important but Overlooked Content 1. AI Tool Utilization: The FDA is open to incorporating the AIM-MASH AI pathology tool to improve standardization in biopsy readings, which could reduce variability in the consensus read process [18][43] 2. Long-term Outcomes: The phase 3 study will follow patients for up to 60 months to assess liver-related events, with potential for future studies in F4 populations [41] 3. Market Research Insights: Payers are increasingly focused on early response indicators and adherence to chronic therapies, which could influence reimbursement decisions [38][39] 4. Differentiation from Competitors: Pembidutide's unique mechanism and tolerability profile may provide a competitive edge over existing therapies in the market [28][29] This summary encapsulates the critical insights from the Altimmune conference call, highlighting the company's advancements in the treatment of MASH and its strategic direction moving forward.