Altimmune IncALTannounced topline results from its 24-week (12-week extension) trial of pemvidutide in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD).
Sixty-six of the 83 subjects who completed the initial 12-week Phase 1b NAFLD trial consented to participate in this 12-week extension trial to receive 24 weeks of treatment, and 64 subjects were enrolled.
The trial met its primary endpoint in all pemvidutide treatment groups.
At the 1.8 mg and 2.4 mg doses, subjects receiving pemvidutide achieved mean relative reductions of the liver fat content of 75.2% and 76.4%, respectively.
92.3% and 100% of subjects, respectively, achieved a 30% reduction in liver fat, and 84.6% and 72.7% of subjects, respectively, achieved a 50% reduction in liver fat.
53.8% and 45.5% of subjects, respectively, achieved normalization of liver fat.
Significant reductions in serum alanine aminotransferase (ALT) and corrected T1 (cT1) were observed, both established markers of liver inflammation.
Mean weight loss of 7.2% (placebo adjusted 6.0%) in subjects without diabetes at the 1.8 mg dose.
The company looks forward to the weight loss data from the interim analysis of the MOMENTUM obesity trial in Q1 2023 and commencing a Phase 2b NASH trial in 2023.
Price Action: ALT shares are up 10.20% at $11.31 on the last check Monday.
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