84% of Eligible Patients Transition to Abelacimab in AZALEA-TIMI 71 Atrial Fibrillation Study

In a significant development in cardiovascular medicine, Anthos Therapeutics, Inc. has provided an update on its AZALEA-TIMI 71 study, which focuses on patients with atrial fibrillation. The study, which was halted early due to the overwhelming benefits of abelacimab over rivaroxaban, has now moved into an open-label extension phase. The Data Monitoring Committee (DMC) recommended this extension to allow eligible patients to continue benefiting from abelacimab treatment.

Dr. Christian T. Ruff, Principal Investigator of the study and a renowned cardiology expert, highlighted the remarkable reduction in bleeding incidents associated with abelacimab. Nearly 84% of eligible patients, including many initially treated with rivaroxaban, have opted to continue with abelacimab. The AZALEA-TIMI 71 study, presented at the 2023 American Heart Association congress, revealed that abelacimab significantly reduced major and clinically relevant non-major bleeding by 67%, major bleeding alone by 74%, and gastrointestinal bleeding by 93%, compared to rivaroxaban.

Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics, expressed satisfaction with the transition phase completion, emphasizing the potential of abelacimab to address the unmet needs in atrial fibrillation treatment. He noted that many patients either do not receive anticoagulants or are on sub-therapeutic doses due to the bleeding risks, drug interactions, dosing complexities, or forgetfulness. Abelacimab, if approved, aims to offer protection against blood clots with a reduced risk of bleeding.

Atrial fibrillation (AF) is a prevalent type of irregular heartbeat that can lead to severe complications such as stroke. The Centers for Disease Control and Prevention (CDC) estimates that by 2030, 12.1 million people in the United States will have AF. Despite the importance of anticoagulants in preventing stroke, data indicate that a substantial percentage of AF patients are either untreated or on ineffective doses, posing a significant public health challenge.

Abelacimab is a highly selective, fully human monoclonal antibody that inhibits Factor XI, providing near-complete inhibition. Unlike other medications that interact with the cytochrome P450 system or P-glycoprotein, abelacimab minimizes the risk of drug interactions. It does not require dose adjustments based on age or renal/hepatic status. Designed for subcutaneous monthly administration, abelacimab maintains high levels of Factor XI inhibition. For acute needs, it can also be administered intravenously to provide rapid action.

In the AZALEA-TIMI 71 study, abelacimab demonstrated near-total inhibition of Factor XI. Additionally, a Phase 2 study indicated that a single intravenous dose of abelacimab post-knee surgery significantly reduced venous thromboembolism by 80% compared to enoxaparin. Abelacimab has received Fast Track Designation from the FDA for treating cancer-associated thrombosis and preventing stroke and systemic embolism in AF patients.

The AZALEA-TIMI 71 Phase 2 study was a large-scale trial with over 1,287 participants across 95 global sites. It compared two doses of abelacimab with rivaroxaban, focusing on major and clinically relevant non-major bleeding as primary endpoints. The study’s early termination was due to the significantly reduced bleeding events in abelacimab-treated patients. The optional open-label extension phase was launched to provide further data and continued patient benefits.

Furthermore, the LILAC-TIMI 76 Phase 3 study aims to evaluate abelacimab's efficacy and safety for patients unsuitable for current anticoagulant therapies. This placebo-controlled, double-blind study plans to enroll approximately 1,900 patients worldwide.

Anthos Therapeutics, founded by Blackstone Life Sciences, holds exclusive global rights to develop, manufacture, and commercialize abelacimab. The company is dedicated to advancing care for high-risk cardiovascular patients through innovative therapies.