NGM Bio Presents Positive Phase 2b Results from the ALPINE 4 Trial of Aldafermin in Patients with Compensated Cirrhosis (F4) Due to NASH at AASLD The Liver Meeting

--As previously reported, the ALPINE 4 study met its primary endpoint, with aldafermin 3 mg demonstrating a statistically significant reduction in Enhanced Liver Fibrosis (ELF) score compared to placebo after 48 weeks of treatment--

--ELF, an FDA-approved non-invasive blood test, can be used to predict liver-related events in patients with nonalcoholic steatohepatitis (NASH) and compensated cirrhosis--

--Dose-dependent improvements reported across histologic and multiple non-invasive secondary endpoints in ALPINE 4--

--In the trial, aldafermin treatment up to one year was generally well tolerated with no treatment-related serious adverse events--

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today shared positive, comprehensive results from its Phase 2b ALPINE 4 trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated cirrhosis (liver fibrosis stage 4 or F4) due to NASH in an oral plenary presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting.

The presentation titled “Positive Results from the ALPINE 4 Study: a Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Trial Evaluating Multiple Doses of the FGF19 Analogue Aldafermin in Patients with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis,” is available to conference attendees for the duration of AASLD The Liver Meeting and will be archived on the ‘Publications’ page of NGM Bio’s website here following the meeting. The ALPINE 4 data shared at AASLD The Liver Meeting follow positive topline results on the primary endpoint reported by NGM Bio in May 2023.

Mary E. Rinella, M.D., Professor of Medicine and Director, Metabolic and Steatotic Liver Disease Program at the University of Chicago Pritzker School of Medicine, who gave the oral presentation, commented, “We are pleased to see that the ALPINE 4 study is the first Phase 2b in NASH cirrhosis to reach its primary endpoint. In addition to demonstrating statistically significant reductions in ELF score, the trial primary endpoint, aldafermin also signaled dose-dependent improvements in liver fibrosis and multiple non-invasive secondary endpoints. Compensated cirrhosis due to NASH is a notoriously difficult-to-treat disease with no approved treatment options. It’s very encouraging to see multiple key clinical measurements moving in the right direction in the ALPINE 4 study, a promising achievement in the quest to bring forward safe, effective therapeutics for patients suffering with F4 NASH.”