The Bristol Myers Squibb-Janssen Collaboration Launches Pivotal Phase 3 Librexia Clinical Trial Program Evaluating Milvexian, an Investigational Oral Factor XIa Inhibitor

Rhea-AI Summary

Bristol Myers Squibb (BMY) has launched the Phase 3 Librexia program, which includes three concurrent trials—Librexia STROKE, Librexia ACS, and Librexia AF—targeting nearly 50,000 patients. This program assesses milvexian, an investigational oral factor XIa inhibitor, for improving outcomes in thrombotic conditions. Enrollment in the Librexia STROKE trial has commenced, aiming to demonstrate superiority in stroke prevention alongside standard antiplatelet therapy. Strong Phase 2 data supports this initiative, showcasing milvexian's potential to enhance the benefit-risk profile in treating acute coronary syndromes and atrial fibrillation.

Positive

• Launch of the Phase 3 Librexia program targeting nearly 50,000 patients.
• Initial patient enrollment in the Librexia STROKE trial.
• Strong Phase 2 proof-of-concept data indicating milvexian's differentiated antithrombotic profile.

Negative

• Milvexian is still in the investigational phase and has not received approval.

The Librexia program is the most comprehensive Factor XIa Phase 3 clinical development program, and will provide indispensable data from nearly 50,000 patients across three simultaneous trials including Librexia STROKE, Librexia ACS and Librexia AF

First patient has been enrolled in Librexia STROKE trial

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (Janssen) today announced the launch of the Phase 3 Librexia program studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic).

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

About Milvexian*

Milvexian is an investigational, oral factor XIa (FXIa) inhibitor (antithrombotic) being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia program, the most comprehensive FXIa clinical development program today.

*Milvexian is an investigational agent and has not been approved for use in any country, for any indication.

About the Librexia Program

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 2 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 3, 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.

About Librexia 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.

About AXIOMATIC-SSP and AXIOMATIC-TKR

The milvexian Phase 2 clinical trial program consisted of two Phase 2 studies: AXIOMATIC-TKR, a randomized, open-label, parallel-group, dose-ranging multicenter study that evaluated the efficacy and safety of milvexian versus subcutaneous enoxaparin in patients undergoing elective total knee replacement (TKR) surgery, and AXIOMATIC-SSP, a Phase 2, global, randomized, double-blind, placebo-controlled, dose-ranging study that evaluated the efficacy and safety of milvexian for the prevention of new symptomatic ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel following acute ischemic stroke or transient ischemic attack (TIA).

A total of 3,608 patients were enrolled across both studies. More information can be found on http://www.clinicaltrials.gov (NCT03766581, NCT03891524).

About the Bristol Myers Squibb-Janssen Collaboration

Bristol Myers Squibb and the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), two unsurpassed leaders in cardiovascular care, are determined to close the gap in unmet needs in thrombosis management by overcoming the limits of today’s treatments. ​The collaboration to develop and commercialize milvexian aims to leverage the combined scientific heritage and world-class commercial capabilities of each company, all in service of improved patient outcomes. The collaboration is uniquely equipped to deliver on the promise of FXIa inhibitors and is working diligently to ensure cutting-edge safe and effective treatment options are available for patients.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that milvexian may not achieve its primary study endpoints or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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FAQ

What is the purpose of the Librexia program for BMY?

The Librexia program aims to evaluate the efficacy and safety of milvexian in preventing thrombotic events in various patient populations.

What trials are included in the Librexia program?

The program includes three trials: Librexia STROKE, Librexia ACS, and Librexia AF, studying milvexian in different thrombotic conditions.

What are the expected outcomes of the Librexia STROKE trial?

The trial seeks to demonstrate superiority in stroke prevention when milvexian is used alongside standard antiplatelet therapy.

When did enrollment start for the Librexia STROKE trial?

Enrollment for the Librexia STROKE trial has already begun.

What does the Phase 2 data suggest about milvexian?

The Phase 2 data suggest that milvexian may offer a favorable benefit-risk profile as both a monotherapy and in combination with antiplatelet therapy.