30 Sept 2023 • Topline results from the largest study so far of a factor XI inhibitor - released last week - are indeed very encouraging. The novel factor XI/XIa inhibitor abelacimab, being studied in the AZALEA-TIMI 71 trial, lowered a composite of major and clinically relevant nonmajor bleeding compared with rivaroxaban in patients with atrial fibrillation (AF) at moderate-to-high risk of stroke, the drugmakers have announced.

• AZALEA-TIMI 71 enrolled 1,287 patients from 95 centers in North America, Europe, and Asia and had a median of 21 months of follow-up prior to being stopped. Patients randomized to the rivaroxaban arm received 20 mg oral daily, while those randomized to abelacimab received either 150 mg or 90 mg subcutaneously on a monthly basis.
• The phase 2 AZALEA-TIMI 71 study was stopped early because of an "overwhelming" reduction in major and clinically relevant nonmajor bleeding shown with the factor XI inhibitor abelacimab (Anthos) compared to rivaroxaban for patients with atrial fibrillation (AF).
• Phase 3 trials of these three factor XI inhibitors have recently started for a variety of thrombotic indications, including the prevention of stroke in patients with AF, prevention of recurrent stroke in patients with ischemic stroke, and prevention of future cardiovascular events in patients with ACS.

Very few other data from this study have yet been released. Full results are due to be presented at the American Heart Association Scientific Sessions in November.

“Abelacimab confirms the promise of factor XI inhibition to potentially provide an incredibly safe anticoagulant which would give us the confidence to treat even our most vulnerable patients—such as the frail, elderly, and those with significant comorbidities such as advanced kidney and liver disease—who are often deemed too high-risk for even our safest approved anticoagulants,”said Dr. Christian T. Ruff, senior investigator of the TIMI study group.

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