FDA grants breakthrough designation to progressive pulmonary fibrosis treatment

The FDA granted breakthrough therapy designation to an oral lysophosphatidic acid receptor 1 antagonist that lowered the rate of percent-predicted FVC decline among patients with progressive pulmonary fibrosis.

According to a company press release, BMS-986278 (Bristol Myers Squibb) is being developed as a potential first-in-class therapy for those suffering with progressive pulmonary fibrosis (PPF).

This designation was supported by a phase 2 randomized controlled trial, data from which Healio previously reported on at this year’s European Respiratory Society International Congress.

In this trial, researchers found greater decreases in percent-predicted FVC at 26 weeks among patients receiving placebo, at –4.3%, compared with patients receiving twice-daily BMS-986278 at a 30 mg dose (–2.7%) and 60 mg dose ( –1.1%), revealing a treatment difference of 1.6% (95% CI, –1% to 4.1%) between 30 mg and placebo and 3.2% (95% CI, 0.7%-5.6%) between 60 mg and placebo.

Researchers also noted that the 60 mg dose was associated with a 69% relative reduction in the rate of percent-predicted FVC decline compared with placebo.

Notably, patients assigned BMS-986278 continued to show less decline in percent-predicted FVC compared with the placebo group regardless of use of background antifibrotics and the presence or absence of a usual interstitial pneumonia pattern, according to researchers.

Similar adverse events occurred within the placebo, 30 mg and 60 mg groups.

“[BMS-986278] was safe and well tolerated, with very few treatment discontinuations,” Tamera J. Corte, BSc, MBBS, FRACP, PhD, clinical trial investigator and consultant respiratory physician and director of interstitial lung disease in the department of respiratory medicine at Royal Prince Alfred Hospital, said during her presentation at the European Respiratory Society International Congress.

Breakthrough therapy designation is granted to accelerate development and regulatory review of investigational drugs that are intended to treat serious or life-threatening diseases and conditions.

“The FDA’s breakthrough therapy designation underscores the potential of BMS-986278 as an innovative, first-in-class treatment that may redefine the standard of care for progressive pulmonary fibrosis,” Roland Chen, MD, senior vice president and head of immunology, cardiovascular and neuroscience development at Bristol Myers Squibb, said in the release.

Reference:

Corte T, et al. Abstract 800. Presented at: European Respiratory Society International Congress; Sept. 9-13, 2023; Milan.