BMS fibrosis-trial death raises liver-safety questions, but cause remains uncertain

A fatal case of acute liver injury and multi-organ failure was disclosed in Bristol Myers Squibb’s Phase 3 ALOFT program testing experimental pulmonary-fibrosis drug admilparant. It remains unclear whether the patient received admilparant or placebo because the study is still blinded.

The trial protocol was amended to identify liver injury as a potential risk and add closer monitoring and stopping rules. BMS says most reported liver events were mild or transient, and an independent monitoring committee has recommended that the study continue.

Analysts said the death warrants scrutiny but does not yet establish that admilparant caused it—or that liver toxicity is a risk across the LPA1-inhibitor drug class. They cited the patient’s other medical conditions and the unclear details; some viewed the market reaction as excessive.

BMS expected Phase 3 results in idiopathic pulmonary fibrosis by the end of 2026, with results in progressive pulmonary fibrosis expected early the following year. The readouts may clarify both efficacy and safety.