NASH treatment drug phase IIb study failed, stock price plummeted by 40%

Article source: Medical Rubik's Cube Info

On May 24, NGM Biopharmaceuticals announced the data of a phase IIb clinical study code-named ALPINE 2/3, which aims to evaluate aldafermin in the treatment of non-alcoholic steatohepatitis (NASH) with stage 2 or stage 3 liver fibrosis (F2/ F3) Efficacy of patients.

Aldafermin is a non-carcinogenic engineered analog of the human hormone FGF19, which can significantly reduce liver fat content and improve liver function by targeting various pathogenic pathways of NASH.

The ALPINE 2/3 study is a 24-week randomized, double-blind, placebo-controlled study that aims to evaluate subcutaneous injections of aldafermin 0.

The results of dose-response analysis using the MCP-Mod model showed that compared with the placebo group, at week 24, the proportion of patients with liver fibrosis in the 0.

However, compared with placebo, the study has statistically significant differences in some secondary endpoints, including NASH histopathological improvement (NASH Resolution) (3mg dose group) and multiple non-invasive NASH measurements (including MRI-PDFF) (Hepatic fat content evaluation index), ALT, AST (hepatic inflammation evaluation index) and Pro-C3 (fibrosis marker)) indicate the decrease of liver fat content or the decrease of liver inflammation.

Aldafermin was well tolerated overall, and the occurrence of adverse reactions in each dose group was similar to that of placebo.

NGM is currently conducting a Phase IIb ALPINE 4 study to evaluate the efficacy of aldafermin in the treatment of patients with stage 4 hepatic fibrosis NASH.

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