Anthos Therapeutics has announced that it has enrolled the first patient in LILAC-TIMI 76, a phase 3 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 LILAC-TIMI 76 trial is an event-driven, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of abelacimab relative to placebo on the rate of ischaemic stroke or systemic embolism in patients with AF who have been deemed to be unsuitable for currently available anticoagulation therapy.
Patients in the study will be randomised to receive abelacimab 150mgSC 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 US Food and Drug Administration (FDA) fast-track designation for the prevention of stroke and systemic embolism in patients with AF in September 2022.
“The use of currently available anticoagulants in patients with AF can significantly reduce the risk of stroke, however, the concern over bleeding risk can lead to underutilisation of these agents in a significant proportion of patients who would otherwise benefit from therapy. Data from multiple registries show that approximately 40% of AF patients are not being optimally treated today,” said Dan Bloomfield, chief medical officer at Anthos. “The gap in treatment is especially common in patients who are older adults, those with kidney or liver disease, those needing concomitant antiplatelet therapy, and patients with other factors associated with an increased risk of bleeding.”
“Enrolling the first patient in the LILAC-TIMI 76 study is an important clinical milestone as we continue to evaluate abelacimab as a potential new therapeutic option,” said Marc S Sabatine (Harvard Medical School, Boston, USA) and chair of the Thrombolysis in Myocardial Infarction (TIMI) study group. “Our hope is that by inhibiting Factor XI, we can decouple haemostasis from thrombosis, thereby reducing bleeding, the major barrier to anticoagulation, and allowing more patients to benefit from such therapy.”
In addition to the LILAC-TIMI 76 study, Anthos has already initiated the AZALEA-TIMI 71 trial. It is an event driven phase 2b study evaluating the safety and tolerability of abelacimab compared head-to-head with rivaroxaban in 1,287 patients with atrial fibrillation at moderate-to-high risk of stroke. It completed enrolment 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 AF population that have conditions associated with an increased risk of bleeding.