First patient enrolled in phase III trial evaluating abelacimab in high-risk patients with atrial fibrillation deemed unsuitable for current anticoagulants
Anthos Therapeutics announced that it has enrolled the first patient in LILAC-TIMI 76, a Phase III study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation (AF) deemed unsuitable for current anticoagulants by their physician
The study is targeting to enroll approximately 1900 patients from more than 300 sites across North America, Europe, Latin America, and Asia.
The LILAC-TIMI 76 trial, is an event-driven, randomized, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation (AF) who have been deemed to be unsuitable for currently available anticoagulation therapy. Patients in the study will be randomized to receive abelacimab 150 mg SC or matching placebo once monthly. The study is targeting to enroll approximately 1900 patients from more than 300 sites in North America, Europe, Latin America, and Asia.
Abelacimab received FDA Fast-Track designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation in September 2022.
About the GARDENIA Atrial Fibrillation Patient Registry :The GARDENIA patient registry is a global, multicenter, prospective, non-interventional, observational study that will evaluate treatment patterns and outcomes in segments of the atrial fibrillation population that are often not treated with oral anticoagulants or not treated with oral anticoagulants at guideline recommended doses. The GARDENIA registry is recruiting patients across North America, Europe, and Asia.
In addition to the LILAC-TIMI 76 study, Anthos has already initiated the AZALEA-TIMI 71 trial . It is an event driven phase IIb study evaluating the safety and tolerability of abelacimab compared head-to-head with rivaroxaban in 1287 patients with atrial fibrillation at moderate-to-high risk of stroke. It completed enrollment late last year. Anthos is also enrolling patients in GARDENIA, a large international patient registry designed to evaluate treatment patterns and outcomes in segments of the atrial fibrillation population that have conditions associated with an increased risk of bleeding.
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