Bristol Myers Squibb eyes phase 3 after pulmonary fibrosis drug reduces lung function decline

Bristol Myers Squibb’s idiopathic pulmonary fibrosis therapy reduced the rate of lung function decline in a phase 2 study, providing the evidence needed to start thinking about a late-stage trial.

A 60-mg dose of BMS-986278 reduced the rate of decline 62% on a measure of percent predicted forced vital capacity, which assesses pulmonary function. The company found that the 30-mg dose was not effective on the same measure.

The BMS-986278 trial involved 278 patients over 26 weeks, plus an optional 26-week extension period and a four-week post-treatment follow up period. Patients were allowed to take background antifibrotic treatments. Another group of patients with progressive pulmonary fibrosis is still ongoing. BMS presented the results at the American Thoracic Society 2023 International Conference in Washington, D.C., on Monday.

On safety, BMS-986278 was well tolerated in both treatment arms of the trial with rates of adverse events similar to placebo, according to BMS. Adverse events occurred in 80% of placebo patients, 76% of the 30-mg cohort and 74% of the 60-mg group. The most common events were diarrhea, cough and orthostatic hypotension, which is when your blood pressure suddenly drops upon standing.

Pulmonary fibrosis occurs when the lung tissue becomes damaged and scarred and is characterized by shortness of breath, coughing and fatigue. Cases that cannot be traced back to a cause are referred to as idiopathic pulmonary fibrosis. The damage that occurs with the condition cannot be reversed, and, so far, medications have been unable to halt the course of lung damage.

BMS-986278 is a small-molecule lysophosphatidic acid receptor 1, or LPA1 antagonist. Increased levels of LPA have been associated with pulmonary fibrosis, BMS said. The therapy was developed in-house at BMS.

With the phase 2 success, BMS plans to get working on a phase 3 program, according to Chief Medical Officer Samit Hirawat, M.D.