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AHA: AZALEA-TIMI 71 Study Demonstrates Factor XI Inhibitor Abelacimab Substantially Reduced Bleeding in Patients on Antiplatelet Therapy Compared to Rivaroxaban
Anthos Therapeutics, Inc., News
--Data presented at the American Heart Association Scientific Sessions show a 67% reduction in bleeding for patients on antiplatelet therapy taking abelacimab as compared to rivaroxaban
--AZALEA-TIMI 71 is the largest head-to-head study of a factor XI inhibitor against a direct-oral anticoagulant
CAMBRIDGE, Mass.-- Anthos Therapeutics, Inc., a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of cardiovascular metabolic diseases, presented new data today at the American Heart Association (AHA) Scientific Sessions from its landmark AZALEA-TIMI 71 study that demonstrated the novel factor XI inhibitor abelacimab led to consistent and substantial reductions in bleeding for patients on or off antiplatelet (APT) therapy, as compared to rivaroxaban.
"Given the elevated bleeding risks associated with traditional anticoagulants, particularly when combined with antiplatelet agents, abelacimab may offer a safer alternative for patients with atrial fibrillation,” said Christian T. Ruff, MD, MPH, senior investigator of TIMI Group and director General Cardiology, Cardiovascular Division, Brigham and Women's Hospital. “These data suggest that abelacimab may potentially be an attractive option for those patients who could benefit from anticoagulation and antiplatelet therapy.”
The data demonstrate a 67% reduction in bleeding for patients on APT taking abelacimab 150 mg compared to patients taking rivaroxaban (a 10.6% incidence rate for rivaroxaban to a 3.5% incidence rate for abelacimab 150 mg).[1] As expected, the absolute rate of bleeding observed was higher when rivaroxaban was combined with APT vs. rivaroxaban alone (10.6% vs. 7.7%).[2] However, the rate of bleeding in patients treated with abelacimab 150 mg was similar, regardless of APT use (3.5% abelacimab with APT vs 3.1% abelacimab alone).[3] The absolute risk difference between abelacimab 150 mg and rivaroxaban was also greater in patients on APT compared to those not on APT (7.1% vs 4.6%).[4]
"Many patients taking antiplatelet therapy are simply not prescribed anticoagulants because of the fear of bleeding, leaving them without protection from the risk of stroke,” said Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics. “The absence of a meaningful increase in bleeding when abelacimab is added to APT as demonstrated in this trial is remarkable and provides further evidence that, if approved, factor XI inhibitors are likely to transform how physicians will approach treating patients who need to be anticoagulated to reduce their risk of stroke.”
AZALEA-TIMI 71 Antiplatelet Therapy Patient Details
- Patient Population: Out of the 1,287 patients enrolled in the study, 318 (25%) were already taking antiplatelet therapy (APT), which is medication to prevent blood clots. APT included either aspirin alone (16%), another type of drug called P2Y12 (7%), or both (DAPT – dual antiplatelet therapy) (2%).
- Patient Demographics: Patients on APT had a higher rate of coronary artery disease (70% vs. 42%), previous heart attacks (36% vs. 16%), and peripheral artery disease (15% vs. 11%).
About Anthos Therapeutics
Founded by Blackstone Life Sciences (BXLS) in 2019, Anthos Therapeutics is a transformative, clinical-stage biopharmaceutical company with the exclusive global rights from Novartis Pharma AG to develop, manufacture and commercialize abelacimab. For more information, visit the Company’s website and follow on Twitter and LinkedIn.
About the AZALEA-TIMI 71 Study
Launched in February, 2021, the AZALEA-TIMI 71 study enrolled 1,287 patients across 95 global study sites, including the U.S. and Canada, Europe and Asia. With a median follow-up of 2.1 years, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a factor XI inhibitor compared to a standard-of-care anticoagulant.
About Abelacimab
Abelacimab is a novel, investigational, highly selective, fully human monoclonal antibody that binds tightly to factor XI to block its activation and prevent the generation of the activated form (factor XIa). This mimics natural factor XI deficiency, which is associated with protection from thromboembolic disease.[5]
As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low.[6] There is no need to adjust the dose based on age or renal/hepatic status.[7]
Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.[8] Abelacimab is the only factor XI inhibitor being studied for both conditions.
If approved, abelacimab is planned to be dosed subcutaneously (SC) monthly by patients with atrial fibrillation using an autoinjector to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration.
In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited factor XI by 99%.[9] In a PK/PD study, abelacimab administered by IV provided profound suppression of factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.[10] In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.[11]
Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Abelacimab is an investigational agent and is not approved for any indication in any country.
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