![]() Rate of change in ppFVC from baseline through 26 weeks in the PPF cohort was a key secondary endpoint of the study and was assessed based on two prespecified estimands* (treatment policy estimand and while-on-treatment estimand). The primary endpoint of the study was rate of change in ppFVC from baseline to Week 26 in the IPF cohort. ![]() Stable background use of antifibrotics in the IPF cohort and/or select immunosuppressives in the PPF cohort were allowed. This Phase 2 study was a global, randomized trial in which parallel cohorts of patients with idiopathic pulmonary fibrosis (IPF) and PPF received 30 mg or 60 mg of BMS-986278 or matched placebo orally twice-daily for 26 weeks. “The Phase 2 progressive pulmonary fibrosis results, which demonstrate consistent efficacy with or without background antifibrotic therapy and a favorable tolerability profile, reinforce the potential of BMS-986278 and highlight advancements in the space as we race to find a potential new standard of care.” Corte, clinical trial investigator and Consultant Respiratory Physician and Director of Interstitial Lung Disease, Department of Respiratory Medicine, Royal Prince Alfred Hospital. “People living with pulmonary fibrosis are in urgent need of new treatment options for this devastating disease, which has a median overall survival of 3-5 years,” said Professor Tamera J. These data will be presented during the Abstracts Leading to Evolution in Respiratory Medicine Trials (ALERT) session 1 at the European Respiratory Society (ERS) 2023 International Congress held September 9-13 in Milan, Italy. The study showed that twice-daily administration of 60 mg of BMS-986278 over 26 weeks reduced the rate of decline in percent predicted forced vital capacity (ppFVC) by 69% compared to placebo (overall, 38% of patients in the study received background antifibrotic therapy). PRINCETON, N.J.-(BUSINESS WIRE)- Bristol Myers Squibb (NYSE: BMY) today announced results from a Phase 2 study evaluating BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA 1) antagonist in patients with progressive pulmonary fibrosis (PPF). ![]() These progressive pulmonary fibrosis findings, along with the previously reported idiopathic pulmonary fibrosis cohort results, support continued development of BMS-986278 in Phase 3 ALOFT program Treatment effect was consistent with or without background therapy and BMS-986278 was well tolerated, with rates of adverse events similar to placebo and low discontinuation rates Results show 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in percent predicted forced vital capacity versus placebo ![]()
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