Bristol Myers Squibb has amended its Phase 3 Aloft trial of admilparant to increase liver safety monitoring following a patient's death from liver injury. While it remains unclear if the drug caused the death, the news has revived historical concerns over liver toxicity in the LPA1R inhibitor class. Shares of Bristol Myers Squibb and Contineum Therapeutics fell on September 29, 2026, but analysts suggest the market reaction is overdone ahead of the late 2026 trial readout.
Trial amendments and patient death details
- ▪A Bristol Myers Squibb spokesperson confirmed on September 30, 2026, that it remains unclear whether the participant who died from liver injury in the Phase 3 Aloft trial actually received the experimental drug admilparant
- ▪Bristol Myers Squibb amended its Phase 3 "Aloft" trial of admilparant for European Union sites in May 2026, classifying liver injury as a newly identified important potential risk following a participant's death
Trial safety data
- ▪Outside trial monitors have regularly reviewed unblinded safety data for the admilparant study and recommended that the trial continue as planned
- ▪Most of the reported safety events in Bristol Myers Squibb's Phase 3 Aloft trial of admilparant were mild, transient, or consistent with hepatic adaptation to the drug therapy
Analyst views on safety implications
- ▪RBC Capital Markets analyst Brian Abrahams stated that the admilparant trial news is likely to reaffirm historical concerns around liver toxicity for the LPA1R drug class
- ▪Leerink Partners analyst Roanna Ruiz stated that the admilparant trial's safety issue may not be a drug-related or LPA1-class issue, calling the brief Bristol Myers stock pullback overdone
- ▪Stifel analyst Paul Matteis noted that Contineum Therapeutics' drug is designed differently and is being tested at doses as low as 10 milligrams daily to reduce liver damage risks
Stock market impact on developers
- ▪Contineum Therapeutics is developing an LPA1R inhibitor drug similar to admilparant, making its stock price sensitive to safety updates from Bristol Myers Squibb's admilparant trial
- ▪Shares of Bristol Myers Squibb and Contineum Therapeutics fell sharply in late-day trading on Tuesday, September 29, 2026, before rebounding early on Wednesday, September 30, 2026
Historical challenges of LPA1R inhibitors
- ▪Amgen shelved an experimental LPA1R inhibitor drug that the company had inherited during its acquisition of Horizon Therapeutics
- ▪LPA1R inhibitors, designed to slow idiopathic pulmonary fibrosis, have faced historical clinical research difficulties, including Bristol Myers Squibb canceling an earlier LPA1R inhibitor drug due to liver toxicity
Debatable claims
- ▪Bristol Myers' new liver monitoring protocol is sufficient to protect admilparant trial participants
- ▪Bristol Myers should pause the admilparant trial until the patient's cause of death is determined
- ▪The historical toxicity of LPA1R inhibitors justifies halting development of the entire drug class
Story comments
Loading comments…