NGM Phase IIb NASH Failure Could Darken Competitors’ Prospects

 
• By Joseph Haas

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.

Business strategy failure as a despair metaphor or financial market drop and psychological burnout symbol in a 3D illustration style.
NGM hopes investors will be enthused about its pipeline as it moves away from NASH

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.

During a 24 May investor call to overview the topline ALPINE 2/3 data, NGM CEO David Woodhouse said his company has decided not to go forward with a planned Phase III study of aldafermin (NGM282) in NASH patients with F2/F3 fibrosis scores

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