NGM Bio Presents Comprehensive Findings from 24-Week Phase 2 Study (Cohort 4) of Aldafermin in Oral Plenary Presentation at The Digital International Liver Congress (ILC) 2020 and Announces Enrollment Completed in Phase 2b ALPINE 2/3 Study

• Late-breaker presentation selected as “Best of ILC”
  
• The 24-week Phase 2 study met its primary endpoint, achieving a statistically significant reduction in liver fat content (LFC), and robust fibrosis improvement and resolution of NASH, with a favorable safety profile
• New analysis shows 30% placebo corrected anti-fibrotic response rate among NASH patients with more advanced liver fibrosis (F3)
• NGM Bio anticipates Phase 2b ALPINE 2/3 study topline data readout in Q2 2021

SOUTH SAN FRANCISCO, Calif., Aug. 29, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that final data from its 24-week Phase 2 study (Cohort 4) of aldafermin 1 mg in patients with non-alcoholic steatohepatitis (NASH) were featured in a late-breaker oral plenary presentation today (LBO-01) at The Digital International Liver Congress (ILC) 2020. The presentation included a new analysis of Cohort 4 data from NASH patients with stage 3 liver fibrosis (F3) 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 (F2) 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 ≥ 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 (Cohort 4) 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 >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 ≥30% LFC reductions showed that 46% of patients treated with aldafermin 1 mg had fibrosis improvement of ≥1 stage without worsening of NASH compared to 0% of placebo patients.