
NGM exits Nash, in latest setback for the field
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 | |||
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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 |