Altimmune(US:ALT)2025-06-26 13:30Altimmune (ALT) Conference Call Summary - June 26, 2025 Company and Industry Overview - Company: Altimmune, Inc. - Industry: Biopharmaceuticals, specifically focusing on treatments for metabolic dysfunction associated with steatohepatitis (NASH) Key Points and Arguments 1. IMPACT Phase 2b Trial Results: The conference call focused on the top-line results from the IMPACT Phase 2b trial of pembidutide in NASH, highlighting significant findings related to NASH resolution and fibrosis improvement [7][8][29] 2. Trial Design: A total of 212 subjects were enrolled with three treatment arms: placebo, pembidutide 1.2 mg, and pembidutide 1.8 mg, administered weekly for 48 weeks. The primary endpoints were assessed via liver biopsy at 24 weeks [10][11] 3. NASH Resolution Rates: Pembidutide achieved a NASH resolution rate of 59.1% compared to 19.1% for placebo, indicating a highly significant treatment effect [14][30] 4. Fibrosis Improvement: Although positive trends in fibrosis improvement were observed, statistical significance was not achieved. The absolute fibrosis improvement was 34.5% for the 1.8 mg dose, similar to other candidates [17][29] 5. Weight Loss: Significant weight loss of up to 6.2% was reported at the 1.8 mg dose at 24 weeks, with the potential for greater weight loss with a higher dose of 2.4 mg [23][30] 6. Safety and Tolerability: The trial demonstrated a low discontinuation rate due to adverse events, with rates less than placebo, indicating a favorable safety profile [25][30] 7. AI-Based Analyses: AI-based readings showed significant reductions in fibrosis, suggesting that longer treatment durations could yield statistically significant results for fibrosis improvement [19][29] 8. Regulatory Pathway: The data positions pembidutide favorably for Phase III success and potential regulatory approval, with expectations of achieving statistical significance in both NASH resolution and fibrosis improvement [29][30] Additional Important Content 1. Placebo Response: The conference discussed the high placebo response rates observed in the trial, which were attributed to the methodology used in biopsy readings. The team is considering alternative methods for Phase III to mitigate this response [46][52] 2. Future Trials: Plans for Phase III trials are underway, with discussions about potentially using a higher dose of 2.4 mg and innovative designs to accelerate enrollment [84][86] 3. Comparative Positioning: Pembidutide is positioned as a highly differentiated product in the NASH market due to its combination of NASH resolution, weight loss, and favorable tolerability compared to other treatments like semaglutide and tirzepatide [96][98] 4. Market Potential: The call emphasized the high prevalence of NASH and the need for effective treatments, positioning pembidutide as a potential foundational therapy in this space [38][76] This summary encapsulates the critical findings and discussions from the Altimmune conference call, providing insights into the company's progress and future directions in the treatment of NASH.