Posted In General News on November 21, 2023
The TidalHealth Richard A. Henson Research Institute is overjoyed to share with you the successes of one of their clinical trials, AZALEA-TIMI 71. AZALEA is a phase 2 trial intended to evaluate the safety and tolerability of Abelacimab, a novel anticoagulant, compared with rivaroxaban in patients with atrial fibrillation who are at risk of having a stroke.
Anthos Therapeutics developed Abelacimab to meet the urgent need for an anticoagulant that prevents thromboembolic events (i.e., strokes and heart attacks caused by blood clots) without significantly increasing the risk of bleeding. Current anticoagulants prevent thromboembolic events, but they also impact the body’s ability to stop bleeding when needed. This forces practitioners to choose between adequate anticoagulation with risk for drug-induced bleeding OR inadequate anticoagulation with higher risk for thromboembolic events.
Last week, at the 2023 American Heart Association Conference in Philadelphia, Anthos Therapeutics announced results of the AZALEA clinical trial demonstrating a highly significant reduction in all bleeding outcome measures when compared with rivaroxaban. This includes a 67% reduction in clinically relevant non-major bleeding events, a 74% reduction in major bleeding, and 93% reduction in gastrointestinal bleeding. In fact, the study was stopped early by the Data Monitoring Committee due to the overwhelmingly positive results favoring Abelacimab. As a result, Abelacimab subcutaneous injection will continue to be studied and all eligible participants will have the option to enroll in the open label extension period of the trial and receive Abelacimab for the next two years.
This clinical trial has enrolled over 1200 patients across 95 sites in the U.S., Canada, Europe, and Asia. At TidalHealth, the Advanced Therapeutics team of the Richard A. Henson Research Institute has been enrolling patients into the AZALEA clinical trial since spring of 2021. AZALEA at TidalHealth is led by Principal Investigator, Dr. Steven Hearne, and has 16 participants. The team is proud to report our successes in clinical trials like this. Every participant is a testament to both the participants’ confidence in the AZALEA trial overall and their trust in the team at the TidalHealth Richard A. Henson Research Institute.
The Richard A. Henson Research Institute is proud to serve the community and bring novel investigational products, like Abelacimab, to Delmarva. To learn more about clinical trial research at TidalHealth, visit our research page. To learn more about Abelacimab specifically, visit the Anthos Therapeutics site.
