Syndax Pharmaceuticals halts axatilimab development for lung disease

Syndax Pharmaceuticals has announced it will cease development of axatilimab for the treatment of idiopathic pulmonary fibrosis (IPF) after a mid-stage clinical trial failed to meet its primary objective. The 26-week MAXPIRe study, which involved approximately 145 patients across 62 sites in 14 countries, did not show that the drug reduced the annual rate of lung function decline compared to a placebo.

Despite the failure to meet the primary endpoint of slowing forced vital capacity decline, the company noted that the treatment was well tolerated. Safety profiles were comparable to the placebo, with no new safety concerns or treatment-related deaths reported. Secondary measures, including quality-of-life scores and time to disease progression, also showed no evidence of benefit.

Following the announcement, Syndax shares fell between 15% and 17% in extended trading. The company stated that the trial results do not impact the ongoing development of axatilimab for other conditions. The drug, marketed as Niktimvo, is already approved in the United States for chronic graft-versus-host disease. Syndax and its partner, Incyte, continue to study the treatment for newly diagnosed chronic graft-versus-host disease, with further results expected in late 2024 and early 2028.