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Syndax Halts Axatilimab Development After Phase 2 Trial Misses Goal

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SNDX$16.55 −2.59%

Syndax Pharmaceuticals Inc (NASDAQ:SNDX) announced that its Phase 2 trial evaluating axatilimab in patients with idiopathic pulmonary fibrosis did not meet its primary endpoint. The 145-patient study, known as MAXPIRe, showed that the drug failed to improve the annualized rate of decline in forced vital capacity compared with a placebo. Following the result, the company plans to discontinue all further clinical development of axatilimab in this indication.

Despite failing to achieve its efficacy objective, axatilimab was well tolerated throughout the 26-week study. Its safety profile was comparable to placebo, and no new safety issues were identified. Shares of Syndax traded down 2.59% to 16.55 USD following the announcement.

The outcome in lung fibrosis does not impact other ongoing studies for axatilimab. The antibody, which is marketed under the brand name Niktimvo for chronic graft-versus-host disease, continues to advance in frontline trials alongside partner Incyte. Syndax expects upcoming study results in that indication later this year and in early 2028.

Key points

  • Syndax Pharmaceuticals is stopping axatilimab development for idiopathic pulmonary fibrosis after Phase 2 study results missed the primary goal.
  • The Phase 2 MAXPIRe trial evaluated 145 patients across 62 sites and showed axatilimab had a safety profile similar to placebo.
  • The negative trial results do not affect ongoing studies of axatilimab in chronic graft-versus-host disease.
  • Syndax expects additional readouts from its chronic graft-versus-host disease clinical program later this year and in early 2028.

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Questions and answers

Why is Syndax stopping axatilimab development for idiopathic pulmonary fibrosis?

The Phase 2 MAXPIRe trial failed to meet its primary endpoint of reducing the annualized rate of decline in forced vital capacity.

Does this trial result affect Niktimvo for chronic graft-versus-host disease?

No, ongoing clinical trials evaluating axatilimab in chronic graft-versus-host disease are unaffected by the lung fibrosis study results.