Results of the phase 2 study evaluating BMS-986278, an orally administered lysophosphatidic acid receptor 1 antagonist, demonstrate significant improvement of the predicted forced vital capacity (ppFVC) decline in patients with idiopathic pulmonary fibrosis (IPF), Bristol Myers Squibb announced.
The biopharmaceutical company presented the data at the American Thoracic Society 2023 International Conference held this May, in Washington, DC.
“As a treating physician, I am acutely aware of the urgent need for new pulmonary fibrosis treatment options that can improve symptoms, address the underlying cause of disease, and are well tolerated by patients,” said Tamera J. Corte, clinical trial investigator and consultant respiratory physician and director of Interstitial Lung Disease, department of respiratory medicine, Royal Prince Alfred Hospital.
“These phase 2 data for this potential first-in-class oral lysophosphatidic acid receptor 1 antagonist represent important progress for patients and physicians alike, who are eager for a new standard of care that can mitigate the decline of lung function.”
Read more about IPF experimental therapies
According to the results, twice daily administration of 60 mg of BMS-986278 over 26 weeks led to a 62% relative reduction in the rate of change in ppFVC versus placebo in the while-on-treatment analysis and a 54% reduction versus placebo in the treatment policy analysis.
The Bayesian analysis also found a greater than 95% probability that 60 mg of the experimental drug would be superior to a placebo in reducing the rate of decline in ppFVC over 26 weeks in both the while-on-treatment and treatment policy estimates. However, the 30 mg dose was ineffective in comparison with placebo.
“These phase 2 data give us the confidence to initiate our global phase 3 clinical trial program where we will continue exploring BMS-986278 as a potentially new and meaningful therapeutic option for people with pulmonary fibrosis,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb.
Moreover, BMS-986278 was well-tolerated among all patients. The adverse event rates, including the rates of gastrointestinal side effects, and treatment discontinuation were all comparable with placebo. The study participants most often reported diarrhea, cough, and orthostatic hypotension as adverse events.
Bristol Myers Squibb’s investigational LPA1 antagonist reduces the rate of lung function decline in patients with idiopathic pulmonary fibrosis. News release. Bristol Myers Squibb; May 22, 2023.