Anthos Therapeutics, Inc., a cutting-edge clinical-stage biopharmaceutical company focused on developing innovative treatments for cardiovascular and metabolic diseases, announced significant findings from the AZALEA-TIMI 71 study at the European Society for Cardiology (ESC) Congress. The study revealed that approximately 1% of patients treated with abelacimab, an investigational Factor XI inhibitor, experienced major or clinically relevant non-major procedural bleeding during invasive procedures. Given that around 20% of patients on anticoagulants undergo invasive procedures annually, often requiring interruption of their therapy, this finding is particularly noteworthy for the management of atrial fibrillation patients using anticoagulants for stroke prevention.
Dr. Siddharth Patel, a Cardiologist at Brigham and Women’s Hospital and a presenting investigator from the TIMI Study Group, highlighted the significance of these results. He noted that the data suggests long-acting Factor XI inhibition with abelacimab could be a feasible alternative in atrial fibrillation patients, potentially reducing the need to interrupt anticoagulation before elective procedures. Traditionally, anticoagulation with DOACs (direct oral anticoagulants) or warfarin is paused for most elective surgeries, but abelacimab may eliminate this need, offering a safer approach.
Atrial fibrillation (AF), which affects 60 million people globally, is a leading cause of stroke, preventable with anticoagulants. The prevalence of AF is expected to surge by 60% by 2050 due to aging populations and increasing cardiometabolic risk factors. In the United States alone, the CDC projects that 12.1 million people will have AF by 2030.
Mellanie True Hills, CEO of StopAfib.org and the American Foundation for Women’s Health, emphasized the potential impact of abelacimab on patient care. She pointed out that many patients find it distressing to temporarily stop their anticoagulant therapy for procedures. Abelacimab could alleviate this concern by allowing patients to continue their treatment uninterrupted, thereby reducing stress and anxiety.
Abelacimab is a novel, fully human monoclonal antibody designed to selectively inhibit Factor XI, preventing its activation and subsequent formation of Factor XIa. This mechanism mimics natural Factor XI deficiency, which is linked to protection against thromboembolic diseases.
Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics, added that these findings bolster the promise of Factor XI inhibition in preventing thrombotic events without compromising normal hemostasis. Even in high-risk situations like surgeries, patients treated with abelacimab exhibited a very low rate of bleeding despite near-complete inhibition of Factor XI. This safety profile makes abelacimab a promising, potentially safer, and more convenient anticoagulant option for patients, pending regulatory approval.
