Bristol Myers Squibb, JnJ stop Phase 3 Librexia ACS trial evaluating milvexian
Princeton: Bristol Myers Squibb in collaboration with Johnson & Johnson has announced the decision to stop the Phase 3 Librexia ACS trial evaluating the efficacy and safety of milvexian when added to the standard of care (conventional antiplatelet therapy) for patients after a recent acute coronary syndrome (ACS) event. The decision to discontinue the trial follows a preplanned interim analysis by the Independent Data Monitoring Committee (IDMC), which determined the trial is unlikely to meet the primary efficacy endpoint.
No new safety concerns related to the investigational therapy were identified. The safety profile was consistent with previously reported studies of milvexian.
The Librexia clinical trial program includes two other Phase 3 trials, Librexia AF for patients with atrial fibrillation (AF) and Librexia STROKE for secondary stroke prevention (SSP). The IDMC recommended these trials continue as planned, with topline data expected in 2026.
“Together with Johnson & Johnson, we remain confident in the potential of milvexian to redefine anticoagulant therapy and provide patients and clinicians a new therapeutic option for reducing thrombosis risks without significantly increasing potential bleeding risks,” said Roland Chen, MD, senior vice president, drug development, Immunology and Cardiovascular Medicines, Bristol Myers Squibb. “Our belief in both the SSP and AF studies remains high and is rooted in robust data from large Phase 2 clinical studies conducted in relevant patient populations and on different background treatment. The Librexia SSP and AF studies are distinct from Librexia ACS in several aspects, including patient populations, endpoints, type and duration of background therapy and disease pathology.”
Study investigators will be updated, and the data will be shared with the scientific community at a future medical congress.
“This news confirms the complexity of treating ACS and the need to further advance knowledge of the disease,” said Robert A. Harrington, MD, the Stephen and Suzanne Weiss Dean of Weill Cornell Medicine and provost for medical affairs of Cornell University, and Librexia program chair. “Given that milvexian did not lead to any new safety concerns in this trial, the inhibition of factor XIa continues to be a promising mechanism within the broader thrombotic treatment space that may lead to advances beyond the standard of care for thrombotic diseases.”
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