BioCentury
ARTICLE | Clinical News

BMS's IPF therapy discontinued after Phase II safety signal

September 13, 2018 10:40 PM UTC

Data published in Chest showed that a twice-daily 600 mg dose of BMS-986020 from Bristol-Myers Squibb Co. (NYSE:BMY) significantly slowed the rate of decline in forced vital capacity (FVC) vs. placebo in the Phase II IM136003 trial to treat idiopathic pulmonary fibrosis (IPF), but the trial was terminated for safety reasons.

The published data showed that in 108 evaluable patients with IPF, those who received twice-daily 600 mg BMS-986020 had a decline in FVC of 0.042 L per 26 weeks vs. a decline of 0.134 L per 26 weeks in patients who received placebo (p=0.049). The once-daily 600 mg dose of BMS-986020 did not show a significant difference in FVC decline vs. placebo (p=0.194). Discontinuation of the double-blind, international trial was precipitated by three treatment-related cases of cholecystitis...