NGM exits Nash, in latest setback for the field

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Despite NGM Bio’s trial of aldafermin in Nash hitting some secondary endpoints the company has decided not to push on with the programme, saying it will not be ploughing cash into another study. The phase 2b Alpine 2/3 study, in patients with stage 2/3 fibrosis, failed to meet the primary endpoint, fibrosis improvement by at least one stage with no worsening of Nash, with aldafermin versus placebo. The company's shares plummeted 40% in early trading. Alpine 4, in patients with very advanced fibrosis and compensated cirrhosis, will continue, and NGM has an option to jump on board with MK-3655, an insulin sensitiser out-licensed to Merck & Co; effectively, however, one of the investment community's most closely-followed Nash plays looks to have thrown in the towel in this disease. Several other companies are looking at fibroblast growth factors, but the news is another reminder that Nash is an incredibly tough target, despite a huge amount of hope, and hype, in the past few years. NGM's attention will now turn to its remaining pipeline, which includes NGM621 in phase 2 in geographic atrophy. The project is an anti-complement C3 antibody, much like Apellis’s intravitreal pegcetacoplan, which is due to report phase 3 data in the third quarter.

Phase 2 fibroblast growth factors for Nash
Product Company Mechanism of Action Note
Pegbelfermin (BMS-986036) Bristol-Myers Squibb/Ambrx FGF21 stimulant Falcon 1 and 2 studies had primary completion dates in Sept 2020
Aldafermin NGM FGF19 analog Alpine 2/3 study failed, Alpine 4 ongoing PC June 22
Efruxifermin (AKR-001) Amgen/Akero FGF21 stimulant Two parallel Ph2b in fibrosis stage 2/3 (Harmony) and F4 to start this year, data Q3 2022
MK-3655 (NGM313) Merck/NGM FGFR1c antibody Ph2b (fibrosis stage 2/3) PC 2023
BIO89-100 89bio FGF21 stimulant Ph2b Enliven expected to start Q2 (fibrosis stage 2/3)
Source: Evaluate Pharma, clinicaltrials.gov

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