- Altimmune Inc ALT shares plunged after topline results from its 12-week Phase 1b study of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD).
- The trial assessed three dose levels, 1.2 mg, 1.8 mg, and 2.4 mg.
- The trial met its primary endpoint in all pemvidutide treatment groups.
- At the 1.8 mg dose (with and without diabetes), pemvidutide achieved a mean reduction of the liver fat content of 68.5%, with 94.4% of subjects achieving a 30% reduction in liver fat, 72.2% achieving a 50% reduction in liver fat, and 55.6% of subjects achieving normalization of liver fat.
- In addition, mean liver enzyme levels declined in all subjects. In subjects with baseline serum ALT above 30 IU/L, levels declined more than 17 IU/L at all doses and 27.0 IU/L in the 2.4 mg dose cohort.
- Related: See Why Altimmune Stock Plunged After Obesity Trial Data.
- The trial also met its key secondary endpoint in all pemvidutide treatment groups, with mean weight losses of 4.9% (placebo-adjusted 4.7%) in subjects without diabetes and 4.4% in subjects with diabetes (placebo-adjusted 3.9%) achieved at the 1.8 and 2.4 mg doses, respectively.
- Pemvidutide was reported to be generally well tolerated. Gastrointestinal events comprised most adverse events (AEs), predominantly mild and transient.
- Two subjects treated with pemvidutide discontinued treatment due to AEs, both secondary to gastrointestinal intolerability.
- Price Action: ALT shares are down 44.2% at $11.36 during the premarket session on the last check Wednesday.
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