Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) announced it will halt the clinical development of axatilimab in idiopathic pulmonary fibrosis (IPF) after the drug missed its primary endpoint in the Phase 2 MAXPIRe trial.
The study failed to demonstrate efficacy in reducing the annualized rate of decline in forced vital capacity (FVC, a measure of lung function).
MAXPIRe Clinical Study Results
The 26-week Phase 2 trial enrolled 145 IPF patients. Investigators randomized participants in a 2:1 ratio to receive either axatilimab at 0.3 mg/kg or a placebo every two weeks, stratifying randomization by background antifibrotic therapy use.
Researchers derived the 52-week annualized rate of FVC decline from measurements gathered over a 26-week period using a linear mixed-effects model.
Secondary trial endpoints evaluated time to disease progression, the annualized rate of decline in percent predicted FVC, patient quality-of-life scores, and changes from baseline in percent predicted diffusion capacity for carbon monoxide.
Consistent Safety and Tolerability Profile
Axatilimab demonstrated a safety and tolerability profile consistent with previous clinical studies and comparable to placebo. Investigators identified no new safety signals during the evaluation.
Rates of treatment-emergent adverse events leading to discontinuation remained low across both arms, and common adverse events matched previous trials. Neither study cohort recorded treatment-related fatal adverse events.
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Syndax confirmed that the MAXPIRe results do not affect ongoing trials evaluating axatilimab in other indications.
The U.S. FDA previously approved the first-in-class CSF-1R-blocking monoclonal antibody, known as Niktimvo (axatilimab-csfr), for chronic graft-versus-host disease (cGVHD) in adult and pediatric patients weighing at least 40 kilograms (88.2 pounds) who failed two prior systemic regimens.
Syndax licensed worldwide rights from UCB in 2016 and entered an exclusive global co-development agreement with Incyte in September 2021.
The company continues testing axatilimab in frontline combination trials for cGVHD, including a Phase 2 study with ruxolitinib and a Phase 3 study with steroids.
SNDX Price Action: Syndax Pharmaceuticals shares were down 16.68% to $13.79 at the time of publication on Tuesday, according to Benzinga Pro data.
Photo by Komsan Loonprom via Shutterstock
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