Bristol Myers Squibb Trial Continued After Patient Death
The company confirmed a fatality in a phase 3 study of its pulmonary fibrosis drug candidate.
Updated on Oct. 1, 2026 in Biotech
Bristol Myers Squibb reported a patient death involving multi-organ failure and acute hepatic injury during its phase 3 Aloft trial. An independent data monitoring committee has recommended that the clinical trial program continue despite the fatality.
Why it matters
The trial is investigating admilparant, a potential treatment for pulmonary fibrosis. The safety of the candidate drug remains under close scrutiny following earlier reports of liver toxicity in European clinical trial sites.
The clinical trial for the LPA1 inhibitor admilparant is in phase 3. While a protocol amendment was issued in May 2026 for European trial sites due to liver toxicity concerns, the program is ongoing.
The players
Bristol Myers Squibb
A global biopharmaceutical company that focuses on the discovery and development of medicines for serious diseases.
The details
The patient who died suffered from multi-organ failure and acute hepatic injury while enrolled in the Aloft program. Bristol Myers Squibb has not unblinded the trial data, meaning it is not yet clear whether the adverse event occurred in the treatment or control arm.
Timeline
A protocol amendment was issued for European trial sites in May 2026.
Analysts issued investor notes regarding the trial status on September 30, 2026.
Topline data for idiopathic pulmonary fibrosis is expected by the end of 2026.
Clinical data for progressive pulmonary fibrosis is expected in early 2027.
The Big Picture
This development represents a high-stakes safety test for the ongoing Aloft clinical trial program. It highlights the rigorous oversight required when balancing potential therapeutic breakthroughs with patient safety in late-stage drug development.
The continuation of the trial means that the development timeline for this potential fibrosis treatment remains on schedule for patients currently awaiting new therapies. There is no immediate change for patients, as the drug remains in the clinical research phase.
The takeaway
Clinical trials operate under strict independent monitoring to ensure that patient safety concerns are addressed without prematurely halting potentially life-saving research. Investors and patients should monitor forthcoming topline data for a clearer picture of the drug's safety profile.
Further reading
For more information on current developments in medical research, visit our Biotech section.
