NGM pivots to ophthamology, cancer as NASH failure raises questions about fibrosis endpoint

NGM appears set to move on from NASH after aldafermin missed the primary endpoint in the Phase IIb ALPINE 2/3 trial, but further analyses from the trial will be needed to help explain whether a problem inherent in the fibrosis endpoint contributed to the failure.

On Monday, NGM Biopharmaceuticals Inc. (NASDAQ:NGM) fell $11.57 (41%) to $16.81, shedding nearly $900 million in market cap, after announcing three different doses of once-daily aldafermin missed the primary endpoint of an improvement in fibrosis without worsening of NASH vs. placebo at week 24. The study, which reported data from 143 evaluable patients with F2/F3-stage NASH who had a biopsy at both day 1 and week 24, missed the endpoint both by a dose response-driven statistical analysis using Multiple Comparison Procedure Modeling (MCP-Mod) or a more traditional pairwise comparison (p=0.55 for MCP-Mod). ...