Bristol Myers Squibb (NYSE: BMY) disclosed a pivotal Phase 2 study highlighting that BMS-986278, an investigational oral LPA1 antagonist, reduces the rate of lung function decline in patients with Progressive Pulmonary Fibrosis (PPF) by 69% compared to a placebo. The study, conducted over 26 weeks, involved twice-daily administration of 60 mg of BMS-986278 and will be presented at the European Respiratory Society (ERS) 2023 International Congress.

Desperate Need for New Treatment Options

“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. Corte. “The Phase 2 progressive pulmonary fibrosis results […] reinforce the potential of BMS-986278 and highlight advancements in the space as we race to find a potential new standard of care.”

Study Design and Primary Endpoints

The global, randomized Phase 2 study involved parallel cohorts receiving either 30 mg or 60 mg of BMS-986278 or a matched placebo twice-daily for 26 weeks. Key endpoints included changes in percent predicted forced vital capacity (ppFVC). The 60 mg treatment led to a 69% relative reduction in rate of change in ppFVC versus placebo in a while-on-treatment analysis. These results were consistent irrespective of background antifibrotic therapy.

Safety Profile and Future Prospects

The drug was well-tolerated, with rates of adverse events comparable to those of the placebo and low discontinuation rates due to adverse effects. “The results from this innovative study […] provide us the expertise and confidence to support continued development of BMS-986278 in our global Phase 3 ALOFT program in idiopathic and progressive pulmonary fibrosis,” said Jonathan Sadeh, senior vice president of Immunology Development at Bristol Myers Squibb.

Ongoing Clinical Trials and Collaboration

This Phase 2 study marks another step in Bristol Myers Squibb’s global endeavors to develop innovative treatments for patients with idiopathic and progressive pulmonary fibrosis. The study opens the doors for further in-depth research and the development of the company’s Phase 3 ALOFT program, aimed at tackling this debilitating disease.

  BMS-986278, Bristol-Myers Squibb, Jonathan Sadeh, Progressive Pulmonary Fibrosis, Tamera J. Corte, USA