Janssen collaboration launches pivotal phase III Librexia Clinical Trial Program evaluating milvexian, an investigational oral factor XIa inhibitor

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 II 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 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. More information on the Librexia STROKE trial can be found on http://www.clinicaltrials.gov (NCT05702034).

The Librexia program is the most comprehensive and unrivaled FXIa clinical development program today, studying nearly 50,000 patients across three concurrent clinical trials (Librexia STROKE, Librexia ACS and Librexia AF). Grounded in strong Phase II efficacy and safety data, the Librexia program aims to investigate whether milvexian can enhance the benefit-risk profile associated with treating patients with these three conditions by delivering reduced thrombotic events with no increased risk of bleeding. The program is designed and powered for success to potentially advance beyond the standard of care and help improve outcomes in a wide range of patients with thrombotic diseases.

About Librexia STROKE: Librexia STROKE is a Phase III, randomized, double-blind, parallel-group, placebo-controlled study to demonstrate the efficacy and safety of milvexian in addition to single or dual antiplatelet therapy for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack (TIA). More information can be found on http://www.clinicaltrials.gov (NCT05702034).

About Librexia ACS: Librexia ACS is a randomized, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of milvexian after a recent acute coronary syndrome.

AboutLibrexia AF: Librexia AF is a randomized, double-blind, double-dummy, parallel group, active-controlled study to evaluate the efficacy and safety of milvexian versus apixaban in participants with atrial fibrillation.