• NGM Biopharmaceuticals Inc (NASDAQ: NGM) has reported results from the 24-week Phase 2b ALPINE 2/3 study evaluating aldafermin in non-alcoholic steatohepatitis (NASH) patients with stage 2 or 3 liver fibrosis (F2/F3).
• The study did not meet its primary endpoint evaluating a dose-response improvement in liver fibrosis by more than 1 stage with no worsening of NASH at week 24 (p=0.55).
• The study did achieve statistical significance versus placebo on specific secondary endpoints, including NASH resolution (at the 3 mg dose) and multiple non-invasive measures of NASH, including liver fat content (at the 1 mg and 3 mg doses).
• Given the failure to meet the primary endpoint, the company has decided not to pursue Phase 3 development of aldafermin in F2/F3 NASH; instead will focus on its ophthalmology and oncology portfolio.
• The overall safety profile of aldafermin was consistent with prior studies and similar to that of placebo.
• Patients treated with aldafermin at all three doses studied in the trial demonstrated a comparable frequency of adverse events versus placebo.
• Additionally, Merck & Co Inc (NYSE: MRK) continues the global Phase 2b development of MK-3655, an FGFR1c/KLB agonistic antibody for NASH treatment, which NGM discovered under its collaboration with Merck.
• NGM will host a conference call and webcast with a slide presentation at 8:30 a.m. ET today.
• Price Action: NGM shares are trading 45.4% lower $15.5 in the premarket session on the last check Monday.