Bristol Myers Squibb, Janssen launch Phase 3 Librexia clinical trial program evaluating Milvexian

The Librexia program is unrivaled as the most comprehensive FXIa development program to date and will provide important data from nearly 50,000 patients across three indication-seeking studies: Librexia STROKE, Librexia ACS and Librexia AF. Enrollment has begun for the Librexia STROKE trial, which is evaluating milvexian in addition to standard of care antiplatelet therapy for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack. The Librexia ACS trial, which will evaluate event reduction in acute coronary syndromes in addition to standard of care antiplatelet therapy, and the Librexia AF trial, which will investigate milvexian compared to apixaban in the prevention of stroke in patients with atrial fibrillation, will also initiate during the first half of 2023.

“The depth and breadth of the Librexia clinical development program will capture data in three related but distinct areas of clinical need related to residual risk of thrombotic events and patient bleeding, and evaluate milvexian’s potential to advance beyond the current standard of care and improve patient outcomes in acute coronary syndromes, atrial fibrillation and ischemic stroke,” said Robert Harrington, M.D., Arthur L. Bloomfield professor of medicine and chair of the Department of Medicine, Stanford University, Librexia program chair. “A novel treatment that enhances the benefit-risk profile will be a clinically meaningful and welcomed advance in the treatment of these conditions.”

Important Phase 2 proof-of-concept data for milvexian demonstrated a differentiated antithrombotic profile as both a monotherapy and in combination with antiplatelet therapy. This included data in patients with ischemic stroke or high-risk transient ischemic attack that may suggest a compelling benefit-risk profile, ultimately enabling the initiation of the Librexia program this year.

“The Librexia program is a first-of-its-kind clinical program, with three Phase 3 trials running concurrently that aim to investigate whether milvexian can improve the benefit-risk profile in thrombotic care by delivering reduced thrombotic events with less bleeding for more patients in need,” said Roland Chen, M.D., senior vice president and head, Cardiovascular Development, Global Drug Development, Bristol Myers Squibb. “BMS and Janssen bring deep heritage and expertise in cardiovascular care to this program, in partnership with renowned experts, and we look forward to continuing to evaluate the potential of milvexian to address key unmet medical needs for patients living with thrombotic diseases.”

The Librexia STROKE trial is an event-driven registrational trial powered to show superiority in reducing the risk of stroke/ischemic events on top of standard of care antiplatelet therapy. Librexia ACS and Librexia AF trials are expected to begin enrolling within the first half of 2023. 

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