Bristol Myers Squibb Amends Lung Fibrosis Trial Over Liver Safety Concerns

Key Facts

1Bristol Myers Squibb altered a late-stage clinical trial for the drug admilparant following liver-related safety events.

2The safety events included one patient death, reigniting historical concerns regarding the LPA1R inhibitor drug class.

Bristol Myers Squibb altered a late-stage clinical trial for its pulmonary fibrosis drug, admilparant, following liver-related safety events. BioPharma Dive reported that these safety signals included one patient death involving multi-organ failure, prompting the company to classify liver injury as a newly identified potential risk in the study protocol.

The revisions have reignited historical concerns regarding the LPA1R inhibitor drug class, although analysts from RBC Capital Markets and Leerink Partners suggested it remains unclear if the drug was directly responsible. These trial amendments occur as Bristol Myers Squibb navigates patent expirations for key products, with the company now requiring closer monitoring of enrollees with elevated liver enzymes to determine if treatment should be discontinued.