BMS and Johnson & Johnson Halt Phase 3 Librexia ACS Trial for Milvexian Due to Futility

On November 14, BMS and Johnson & Johnson announced the decision to halt the Phase 3 trial of Librexia ACS, which evaluated the efficacy and safety of adding milvexian to the standard treatment (routine antiplatelet therapy) in patients following a recent acute coronary syndrome (ACS) event. The decision to terminate the trial was made after a pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC), which determined that the trial was unlikely to meet its primary efficacy endpoint. No new safety issues related to the study therapy were identified, and the safety profile was consistent with previously reported milvexian studies.

Librexia Clinical Trial Program Includes Two Additional Phase 3 Trials: Librexia AF for Atrial Fibrillation (AF) Patients and Librexia STROKE for Secondary Stroke Prevention (SSP). The IDMC Recommends These Trials Continue as Planned, with Topline Data Expected in 2026.

Roland Chen, M.D., Senior Vice President of Immunology and Cardiovascular Drug Development at Bristol-Myers Squibb, stated: "Together with Johnson & Johnson, we remain confident in the potential of milvexian to redefine anticoagulation therapy and provide a new treatment option for patients and clinicians to reduce thrombosis risk without significantly increasing the potential risk of bleeding. Our confidence in the SSP and AF studies remains high and is rooted in robust data from large Phase 2 clinical trials conducted across relevant patient populations and various background treatments. The Librexia SSP and AF studies differ from Librexia ACS in several aspects, including patient population, endpoints, types and duration of background treatments, as well as disease pathology."

"Today's news confirms the complexity of treating ACS and the necessity to further advance our understanding of the disease," said Robert A. Harrington, MD, Dean of Weill Cornell Medicine, Stephen and Suzanne Weiss Professor, Provost for Medical Affairs at Cornell University, and Chair of the Librexia program. "Given that milvexian did not lead to any new safety concerns in this trial, the inhibition of Factor XIa remains a promising mechanism in the broader field of thrombosis treatment, which may result in advancements beyond the current standard of care for thrombotic diseases."