Further details from the phase 2b AZALEA trial with the factor XI inhibitor abelacimab (Anthos) show significant reductions in major and clinically relevant nonmajor bleeding compared with rivaroxaban for patients with AF; the risk for stroke was moderate to high.
The trial was stopped earlier this year because of an "overwhelming" reduction in bleeding with abelacimab in comparison rivaroxaban. Abelacimab is a monoclonal antibody given by subcutaneous injection once a month.
Details of the bleeding results have now shown that the 150-mg dose of abelacimab, which is the dose being carried forward to phase 3 trials, was associated with a 67% reduction in major or clinically relevant nonmajor bleeding, the primary endpoint of the study.
In addition, major bleeding was reduced by 74%, and major gastrointestinal (GI) bleeding was reduced by 93%.
"We are seeing really profound reductions in bleeding with this agent vs a NOAC [novel oral anticoagulant]," lead AZALEA investigator Christian Ruff, MD, professor of medicine at Brigham and Women's Hospital, Boston, Massachusetts, commented to theheart.org | Medscape Cardiology.
"Major bleeding ― effectively the type of bleeding that results in hospitalization ― is reduced by more than two thirds, and major GI bleeding ― which is the most common type of bleeding experienced by AF patients on anticoagulants ― is almost eliminated.
