NGM Biopharmaceuticals reports Phase 2b study results from ALPINE 4 trial

NGM Biopharmaceuticals shared results from its Phase 2b ALPINE 4 trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated cirrhosis due to NASH in an oral plenary presentation at the American Association for the Study of Liver Diseases he 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. The ALPINE 4 trial evaluated the efficacy, safety and tolerability of 1 mg and 3 mg doses of aldafermin compared to placebo in 160 patients with compensated cirrhosis due to NASH. The study showed that the primary endpoint was achieved; patients treated with aldafermin 3 mg showed a statistically significant reduction in ELF score compared to the placebo arm after 48 weeks of treatment. ELF is the first and only FDA-approved non-invasive test reflecting NASH prognosis. ELF measures direct markers of liver fibrosis and can be used to predict liver-related events in patients with NASH and compensated cirrhosis. Although ALPINE 4 was not statistically powered for the secondary endpoint of histological fibrosis improvement of greater than or equal to 1-stage, a dose-dependent trend in fibrosis improvement was observed. Aldafermin demonstrated significant, dose-dependent improvements across all of the study’s non-invasive secondary endpoints, including neoepitope-specific N-terminal propeptide of type III collagen, alanine aminotransferase, aspartate aminotransferase, 7alpha-hydroxy-4-cholesten-3-one, bile acids and liver stiffness measurement by FibroScan at week 48. These non-invasive tests are correlated with liver fibrogenesis, liver inflammation and injury, and NASH progression.