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.
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