Mohamed Sikkander Abdul Razak: Factor XIa Inhibitors Show Promise With Lower Bleeding Risk
Mohamed Sikkander Abdul Razak, Professor at GKM College of Engineering Technology, shared a post on LinkedIn:
“Factor XIa inhibitors like Milvexian and Asundexian are showing promise in clinical trials for reducing thrombosis risk with potentially lower bleeding rates compared to traditional anticoagulants.
They work by blocking Factor XIa, a key enzyme in the intrinsic coagulation pathway, reducing clot formation while preserving hemostasis.
These inhibitors are being explored for use in:
- Atrial Fibrillation (AFib): Reducing stroke risk without increasing bleeding complications
- Venous Thromboembolism (VTE) Prevention: Post-surgery or in high-risk patients
- Secondary Stroke Prevention: Reducing recurrent ischemic stroke risk
- Acute Coronary Syndrome (ACS): Potential adjunct therapy
Asundexian (Bayer) has shown promising Phase 3 results in secondary stroke prevention (OCEANIC-STROKE), reducing recurrent ischemic stroke risk by 26% without increasing major bleeding. Milvexian (Bristol Myers Squibb and Johnson and Johnson) is also in Phase 3 trials for AFib and secondary stroke prevention.
Their potential benefits include reduced bleeding risk, making them attractive options for patients at high bleeding risk.
Asundexian and milvexian are in Phase 3 trials, with asundexian showing promising results in secondary stroke prevention. They’re being compared to traditional anticoagulants like DOACs (apixaban, rivaroxaban) which inhibit Factor Xa/thrombin. FXIa inhibitors target the intrinsic pathway, potentially reducing bleeding risk.
Key developments:
- Asundexian: Phase 3 OCEANIC-STROKE trial met primary endpoint, reducing recurrent ischemic stroke risk by 26%
- Milvexian: Phase 3 trials ongoing for AFib and secondary stroke prevention
- Potential benefits: Reduced bleeding risk, attractive for patients at high bleeding risk
Milvexian and asundexian are Factor XIa inhibitors being developed to prevent thrombotic events with potentially lower bleeding risks. Milvexian has received Fast Track Designation from the FDA for ischemic stroke, acute coronary syndrome, and atrial fibrillation, and is being evaluated in Phase 3 trials (Librexia program) involving nearly 50,000 patients.
Asundexian has shown promising results in a Phase 3 trial (OCEANIC-STROKE) for secondary stroke prevention, reducing recurrent ischemic stroke risk by 26% without increasing major bleeding. However, the OCEANIC-AF trial was terminated early due to inferior efficacy in atrial fibrillation.
Bayer’s asundexian, a Factor XIa inhibitor, has shown promising results in reducing the risk of secondary stroke by 26% without increasing bleeding risk in a Phase 3 clinical trial (OCEANIC-STROKE). The trial involved 12,327 patients and met multiple secondary endpoints, including reducing the risk of stroke of any kind, cardiovascular death, myocardial infarction, or stroke.”
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