速递｜一夜股价腰斩！Altimmune GLP-1新药疗效令投资人失望

Core Viewpoint - Altimmune, Inc. announced positive preliminary results from the IMPACT 2b clinical trial of its candidate drug pemvidutide for the treatment of Metabolic Associated Steatotic Liver Disease (MASH), but the efficacy disappointed investors, leading to a significant drop in stock price [2]. Group 1: Clinical Trial Results - The trial recruited 212 participants diagnosed with MASH at F2/F3 fibrosis stages, with a low dropout rate of only 9% [6]. - In the intention-to-treat (ITT) analysis, 59.1% of the 1.2 mg group and 52.1% of the 1.8 mg group achieved MASH resolution without worsening fibrosis, significantly higher than the 19.1% in the placebo group (both p<0.0001) [10]. - For fibrosis improvement without worsening MASH, the improvement rates were 31.8% and 34.5% for the treatment groups, compared to 25.9% for the placebo, but the differences were not statistically significant [11]. - AI-assisted analysis showed that 30.6% of the 1.8 mg group had a fibrosis reduction of over 60%, significantly better than the 8.2% in the placebo group (p<0.001) [12]. - The treatment groups showed significant improvements in non-invasive fibrosis assessment indicators compared to the placebo [13]. Group 2: Weight Control and Tolerability - The average weight loss for the 1.2 mg and 1.8 mg groups was 5.0% and 6.2%, respectively, compared to only 1.0% in the placebo group (both p<0.001) [14]. - The overall tolerability of the drug was good, with only 0.0% and 1.2% of participants in the treatment groups discontinuing due to adverse reactions, lower than the 2.4% in the placebo group [16]. - No serious adverse events related to the treatment were reported [17]. Group 3: Expert Commentary - The CEO of Altimmune expressed confidence in pemvidutide's potential to change the treatment landscape for MASH, a condition expected to affect over 27 million people in the U.S. by 2030 [9]. - An expert noted that achieving MASH resolution and weight loss within 24 weeks is uncommon among similar drugs, highlighting pemvidutide's superior tolerability and low discontinuation rate [9]. - The results indicate a promising trend for fibrosis improvement, and the company plans to advance to Phase 3 trials following a successful Phase 2 meeting with the FDA in Q4 2025 [9].