Syndax Pharmaceuticals (Nasdaq: SNDX) announced that its MAXPIRe Phase 2 trial evaluating axatilimab for idiopathic pulmonary fibrosis (IPF) failed to meet its primary endpoint, which was the annualized rate of decline in forced vital capacity (FVC).
Despite the trial's outcome, the safety and tolerability profile of axatilimab remained consistent with previous studies, showing no new safety concerns.
As a result of these findings, Syndax has decided not to pursue further development of axatilimab for IPF.
However, this decision does not impact ongoing trials of axatilimab for other potential uses.
Axatilimab is a first-in-class monoclonal antibody that blocks CSF-1R and is already FDA approved for treating chronic graft-versus-host disease (cGVHD) in patients who have not responded to at least two prior systemic therapies.
In the IPF trial, axatilimab was well tolerated, with a safety profile similar to placebo, and low rates of treatment-emergent adverse events leading to discontinuation were observed in both treatment groups.
Nick Botwood, Head of Research & Development and Chief Medical Officer at Syndax, said, “The MAXPIRe trial did not meet its primary endpoint, and we are disappointed by this outcome given the promising scientific rationale in IPF. There are multiple trials underway in cGVHD where axatilimab has shown remarkable results and we look forward to readouts from these trials later this year and in early 2028.”