NGM Bio adds to woes in the search for a NASH treatment

Shares of US biotech NGM Biopharmaceuticals (Nasdaq: NGM) closed down more than 40% at $16.81 yesterday, after it revealed a major disappointment with its aldafermin in the treatment of non-alcoholic steatohepatitis (NASH), joining a string of failures in this therapy area.

NGM reported results from the 24-week Phase IIb ALPINE 2/3 study evaluating aldafermin in 171 patients with biopsy-confirmed NASH with stage 2 or 3 liver fibrosis (F2/F3). The study did not meet its primary endpoint evaluating a dose response showing improvement in liver fibrosis by >1 stage with no worsening of NASH at week 24 (p=0.55), analyzed using a dose response-driven statistical analysis plan (Multiple Comparison Procedure Modeling, or MCP-Mod). The study did achieve statistical significance versus placebo on certain secondary endpoints, including NASH resolution (at the 3mg dose) and multiple non-invasive measures of NASH, including liver fat content reduction by MRI-PDFF, ALT, AST and Pro-C3 (at the 1mg and 3mg doses).