Syndax halts axatilimab development for idiopathic pulmonary fibrosis after Phase 2 miss
Syndax Pharmaceuticals announced that its Phase 2 MAXPIRe study of axatilimab in idiopathic pulmonary fibrosis failed to achieve the primary endpoint of reducing the annualized decline in forced vital capacity. The company will discontinue any further work on the drug for IPF, but will keep pursuing ongoing trials in chronic graft‑versus‑host disease. The trial enrolled 145 patients across 62 sites, with participants receiving either axatilimab at 0.3 mg per kilogram or placebo every two weeks.
Why it matters
The setback removes axatilimab from Syndax's pipeline for a new indication, eliminating potential future revenue from IPF. Analysts note that the failure does not affect the drug's approved use in cGVHD, so the company's existing revenue streams remain intact.
Key facts
- 1The MAXPIRe trial was a 26‑week, randomized, double‑blind, placebo‑controlled Phase 2 study involving 145 patients. stocktitan.net
- 2Patients were assigned in a 2:1 ratio to receive axatilimab at a dose of 0.3 mg per kilogram or placebo every two weeks. stocktitan.net
- 3The primary endpoint – the annualized rate of decline in forced vital capacity – was not met. stocktitan.net
- 4Axatilimab was well tolerated with a safety profile comparable to placebo and no new safety signals. stocktitan.net
- 5Syndax will not pursue further development of axatilimab for IPF. stocktitan.net
- 6Shares fell roughly 15% after the announcement, trading near a 52‑week low of $13.59. investing.com
Summary written by AlphAI AI Desk from 11 of 11 sources. Not investment advice. Figures are as stated by the linked sources.