Phase 2 study with FXI inhibitor in AF stopped early due to overwhelming efficacy

The AZALEA-TIMI 71 trial, in which the efficacy of the factor XI/XIa inhibitor abelacimab was compared with rivaroxaban in patients with AF at moderate-to-high risk of stroke, has been stopped early due to an overwhelming reduction in bleeding.

The phase 2 AZALEA-TIMI 71 trial, in which the efficacy of abelacimab was compared with rivaroxaban in patients with AF at moderate-to-high risk of stroke, has been stopped early due to overwhelming benefit of abelacimab. This decision was made by a Data Monitoring Committee, which concluded that patients in the abelicimab group had an overwhelming reduction in the composite of major and clinically relevant non-major bleeding compared with patients in the rivaroxaban group.

Abelacimab is a novel, highly selective monoclonal antibody with dual activity against both factor XI and factor XIa. Prior to the AZALEA-TIMI 71 trial, abelacimab has been shown to reduce the risk of venous thromboembolisim in patients undergoing knee arthroplasty compared with standard-of-care comparator.

AZALEA-TIMI 71 was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study in which 1287 patients with AF who are at moderate-to-high risk of stroke were enrolled. Patients were randomized (1:1:1) to blinded subcutaneous administration of abelacimab 150 mg once monthly or abelacimab 90 mg once-monthly, or open-label rivaroxaban 20 mg daily. The primary endpoint was the composite of the rate of major or clinically relevant non-major bleeding events. The secondary endpoint was major bleeding events. The median follow-up period was 21 months.

The results of AZALEA-TIMI 71 will be presented at an upcoming scientific meeting.

Source: Press Release Anthos Therapeutics, September 18, 2023