Syndax stops development of axatilimab 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 goal of slowing forced vital capacity decline. The company will discontinue the IPF program but will keep the drug in ongoing chronic graft‑versus‑host disease trials. The trial involved 145 patients, with a 2‑to‑1 allocation to axatilimab at 0.3 mg per kilogram every two weeks versus placebo.
Why it matters
The decision removes a potential new revenue source for Syndax and may pressure the SNDX share price, while the cGVHD program remains unchanged. No guidance change was provided, so investors should monitor upcoming cGVHD readouts for future impact.
Key facts
- 1The MAXPIRe trial was a 26‑week, double‑blind, placebo‑controlled phase‑2 study. stocktitan.net
- 2A total of 145 patients were enrolled across 62 sites in 14 countries. stocktitan.net
- 3Patients were assigned in a 2:1 ratio to receive axatilimab 0.3 mg/kg or placebo every two weeks. stocktitan.net
- 4The primary endpoint – the annualized rate of decline in forced vital capacity – was not met. stocktitan.net
- 5Axatilimab showed a safety profile comparable to placebo with no new safety signals. stocktitan.net
- 6Syndax will not pursue further development of axatilimab for IPF, but cGVHD trials will continue. stocktitan.net
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.