Anthos Therapeutics Reveals New Analysis Showing Abelacimab's Low Bleeding Risk in Atrial Fibrillation

Anthos Therapeutics, Inc., a biopharmaceutical company at the clinical stage focused on treating cardiovascular metabolic diseases, revealed new findings from the AZALEA-TIMI 71 study at the European Society for Cardiology (ESC) Congress. This study highlighted that approximately 1% of patients on abelacimab, an investigational Factor XI inhibitor, experienced significant or clinically relevant non-major bleeds during invasive procedures.

Annually, around 20% of patients on anticoagulants undergo invasive procedures, often requiring a pause in their therapy. This common scenario among atrial fibrillation patients underscores the importance of managing perioperative therapies effectively. Dr. Siddharth Patel, a Cardiologist at Brigham and Women’s Hospital, emphasized that these findings support the safety of abelacimab, suggesting that routine interruption of anticoagulation might not be necessary with this medication for elective procedures.

Atrial fibrillation, which can lead to strokes, affects 60 million people globally. This number is projected to rise by 60% by 2050 due to aging populations and increasing cardiometabolic risk factors. The CDC estimates that 12.1 million people in the U.S. will have atrial fibrillation by 2030. Mellanie True Hills, CEO of StopAfib.org, highlighted that abelacimab could alleviate the stress of stopping anticoagulants for procedures, potentially benefiting many atrial fibrillation patients.

Abelacimab is a novel, fully human monoclonal antibody that inhibits Factor XI by blocking its activation. This mechanism mimics natural Factor XI deficiency, which provides protection from thromboembolic diseases. Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics, pointed out that the positive data from the AZALEA-TIMI 71 study reinforces the promise of Factor XI inhibition in preventing thrombotic events without affecting normal hemostasis. Even during surgery, patients treated with abelacimab had a low rate of bleeding.

The AZALEA-TIMI 71 study followed 1,287 patients for a median of 2.1 years, during which 920 invasive procedures took place. The study allowed for the interruption of rivaroxaban before procedures, and results showed that 0.8% of patients on abelacimab experienced procedure-related major bleeds compared to 1.4% of those on rivaroxaban. The study was halted early by the independent Data Monitoring Committee due to a significant reduction in bleeding incidents in the abelacimab group.

The AZALEA-TIMI 71 study was a randomized, active-controlled, blinded endpoint study that compared two doses of abelacimab to rivaroxaban in patients with atrial fibrillation at moderate-to-high risk of stroke. The primary endpoint was the rate of major or clinically relevant non-major bleeding events, with the secondary endpoint focusing on major bleeding alone. Patients received either abelacimab 150 mg or 90 mg once-monthly, or rivaroxaban 20 mg daily. 

The study’s results, presented during the American Heart Association 2023 Scientific Sessions, showed a 67% reduction in major or clinically relevant non-major bleeding with abelacimab compared to rivaroxaban. Specifically, there was a 74% reduction in major bleeding, a 93% reduction in gastrointestinal bleeding, and a 51% reduction in net clinical outcome with abelacimab. Factor XI inhibition was approximately 99% with abelacimab 150 mg dosed once monthly.

Following the early termination of the study, an open-label extension was initiated, where 84% of eligible patients opted to transition to abelacimab. Additionally, the LILAC-TIMI 76 Phase 3 Study is underway to further evaluate the efficacy and safety of abelacimab in patients with atrial fibrillation who are unsuitable for current anticoagulation therapy.

Abelacimab is positioned as a promising therapeutic option due to its unique mechanism and potential to offer hemostasis-sparing anticoagulation for both arterial and venous thromboembolic events. Anthos Therapeutics continues to develop this innovative treatment with the aim of providing safer and more convenient options for patients with cardiovascular metabolic diseases.

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