Bristol Myers Squibb has revised a late-stage study of its experimental pulmonary fibrosis drug admilparant to add closer monitoring for liver-related side effects. The change follows a limited number of liver safety events and the death of a trial participant from liver injury, according to a company spokesperson.
The amendment, submitted to European Union sites in May, classifies liver injury as a newly recognized potential risk and requires closer monitoring of patients with elevated liver enzymes. Most events were mild or transient, and the fatality involved multi-organ failure in a patient with underlying lung disorders and other complications.
The news has reignited concerns about LPA1R inhibitors, a class that has already struggled: Bristol Myers canceled an earlier drug due to liver toxicity, and Amgen shelved another. Analysts cautioned that too many variables exist to conclude a true safety signal, and noted Contineum's similar drug is designed differently and tested at a lower dose.
Bristol Myers expects to report results from the Aloft study by the end of the year, which could clarify the safety profile of admilparant and its class. The company's spokesperson said outside monitors have reviewed unblinded data and recommended the study continue as planned.