Bristol Myers Squibb drug meets IPF trial endpoint

• Bristol Myers Squibb (NYSE:BMY) reported that its investigational drug admilparant met the primary endpoint in a Phase 3 idiopathic pulmonary fibrosis trial at the 60 mg dose.
• The 60 mg dose showed a statistically significant improvement in forced vital capacity compared with placebo after 52 weeks, while the 120 mg dose did not reach statistical significance.
• Bristol Myers Squibb said the results support further regulatory discussions and continued evaluation of admilparant in pulmonary fibrosis trials.

Bristol Myers Squibb (NYSE:BMY) announced topline results from the Phase 3 ALOFT-IPF trial, where admilparant demonstrated a statistically significant improvement in absolute change in forced vital capacity (FVC) from baseline to Week 52 compared with placebo at the 60 mg dose.

The trial evaluated admilparant at 60 mg and 120 mg doses twice daily for at least 52 weeks, with participants randomly assigned across the two treatment groups and placebo.

“Taken together, these topline data reinforce the profile of admilparant as a promising, clinically meaningful investigational therapy for IPF – one that reflects the innovation of targeting the LPA1 pathway as a first-in-class approach,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb.

The company reported that the 120 mg dose slowed FVC decline but did not achieve statistical significance, while both doses showed a safety profile with low and similar adverse-event discontinuation rates compared with placebo.

Bristol Myers Squibb said it will complete evaluation of the Phase 3 ALOFT-IPF data and engage with health authorities regarding planned regulatory submissions, with detailed results expected at a future medical meeting.

The company is also studying admilparant in the fully enrolled Phase 3 ALOFT-PPF trial for progressive pulmonary fibrosis, with topline results expected in early 2027.