June 27, 2022

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NASH treatment drug phase IIb study failed

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

 

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

The results showed that the study did not reach the primary endpoint of the patient’s liver fibrosis improvement ≥ 1 stage and NASH did not worsen at the 24th week. Affected by this news, the company’s stock fell 40.77%.

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 0.3 mg, 1 mg, and 3 mg once a day compared with placebo in the treatment of NASH with phase 2 Or the effectiveness, safety and tolerability of patients with stage 3 liver fibrosis (F2/F3).

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 0.3 mg, 1 mg, and 3 mg dose groups of aldafermin improved ≥ 1 stage and NASH did not worsen. None showed statistical differences.

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)) suggest a decrease in liver fat content or a decrease in liver inflammation.

 

(source:internet, reference only)


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