NGM presents data from 24-week Phase 2 study of aldafermin 1 mg

NGM Biopharmaceuticals announced that final data from its 24-week Phase 2 study of aldafermin 1 mg in patients with non-alcoholic steatohepatitis were featured in a late-breaker oral plenary presentation at The Digital International Liver Congress 2020. The presentation included a new analysis of Cohort 4 data from NASH patients with stage 3 liver fibrosis demonstrating that 1 mg aldafermin had a potent anti-fibrotic effect in these patients with more advanced disease. NGM also announced today that it has completed enrollment in its ongoing Phase 2b ALPINE 2/3 study of 0.3 mg, 1 mg and 3 mg aldafermin versus placebo in patients with biopsy-confirmed NASH with stage 2 and F3 liver fibrosis. The primary objective of the ALPINE 2/3 study is to evaluate a dose response showing an improvement in liver fibrosis by greater than or equal to 1 stage with no worsening of steatohepatitis at Week 24. NGM expects to report topline findings from the study in the second quarter of 2021. Efficacy data from a new secondary analysis of patients with advanced liver fibrosis enrolled in the 24-week Phase 2 study were included in the aldafermin presentation at Digital ILC. In this patient population, 30% of patients with F3 liver fibrosis treated with aldafermin 1 mg achieved fibrosis improvement greater than 1 stage without worsening of NASH compared to 0% in the placebo arm. A responder analysis conducted in patients with F3 liver fibrosis who achieved greater than or equal to 30% LFC reductions showed that 46% of patients treated with aldafermin 1 mg had fibrosis improvement of greater than or equal to 1 stage without worsening of NASH compared to 0% of placebo patients.