NGM Biopharmaceuticals, Inc. missed the primary endpoint in a Phase IIb study intended to show a reduction in fibrosis in non-alcoholic steatohepatitis patients with mid-stage fibrosis (F2/F3) scores, a result both the company and analysts called surprising based on earlier datasets for aldafermin. The daily injectable FGF19 analog had showed ability to reduce fibrosis in NASH patients in a biopsy-based Phase II study while also showing numerous potential liver health benefits measured by non-invasive tests.
NGM Phase IIb NASH Failure Could Darken Competitors’ Prospects
NGM will not proceed with a Phase III study in F2/F3 NASH following failure to show fibrosis benefit in Phase IIb. Analysts say this setback could portend disappointing readouts for other NASH players.
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