Editor’s note: This article has been updated to clarify that the collaboration was with Johnson & Johnson, not AstraZeneca as previously stated.
Bristol Myers Squibb (BMS) and Johnson & Johnson have decided to terminate a Phase III trial of their jointly developed anticoagulant in acute coronary syndrome (ACS) after a data committee determined the drug is unlikely to meet its primary endpoint.
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The Phase III Librexia ACS trial (NCT05754957) was evaluating the efficacy and safety of milvexian, an investigational oral, highly selective factor XIa (FXIa) inhibitor, when added to the standard of care (conventional antiplatelet therapy) for patients after a recent ACS event.
During a planned interim analysis, an Independent Data Monitoring Committee (IDMC) determined that the trial is unlikely to meet the primary efficacy endpoint.
There were no new safety concerns identified in the trial, with the safety profile remaining consistent with previously reported studies of milvexian.
As a result of the anticipated failure, BMS and Johnson & Johnson have jointly decided to terminate the ACS study. While Librexia ACS has been culled, Librexia AF (NCT05757869) for patients with atrial fibrillation (AF) and Librexia STROKE (NCT05702034) for secondary stroke prevention (SSP) will continue as planned, with top line data expected in 2026.
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By GlobalDataWilliam Blair partner and group head of biotechnology equity research Dr Matt Phipps said in a research note that due to the indications sharing underlying biology, the failure in ACS suggests an “incrementally negative read-through” to the Librexia STROKE trial.
Phipps added: “We view the AF indication as being distinct, with the largest market opportunity, and that trial is evaluating a 100mg BID dose, so it may have less read-through from today’s setback.
“Our model currently includes contribution from milvexian in the secondary stroke prevention and nonvalvular atrial fibrillation settings only, and therefore today’s update does not materially change our estimates.”
GlobalData’s patient-based forecast predicts sales of milvexian to reach blockbuster status in AF in 2032, with $1.02bn in sales in the year. This is anticipated based on a 2028 approval in the indication.
GlobalData is the parent company of Clinical Trials Arena.
Currently, the standard of care (SoC) for ACS both manages symptoms and prevents complications associated with events. This includes treatment with thrombolytics and antiplatelet drugs to break up blood clots, nitroglycerin or angiotensin-converting enzyme (ACE) inhibitors to widen blood vessels and beta blockers to slow the heart rate. Finally, physicians may also use angiotensin 2 receptor blockers (ARBs) to control blood pressure and statins to reduce the patient’s cholesterol.
