Abelacimab trial for AF stopped early due to ‘overwhelming’ reduction in bleeding
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Key takeaways:
- The AZALEA-TIMI 71 trial stopped early due to an unprecedented bleeding benefit for adults with atrial fibrillation.
- Abelacimab is the first factor XI inhibitor to show a reduction in major bleeding vs. a DOAC.
Anthos Therapeutics announced that the phase 2 AZALEA-TIMI 71 study was stopped early due to an “overwhelming reduction” in bleeding in patients with atrial fibrillation at high risk for stroke taking abelacimab vs. rivaroxaban.
In a press release, Anthos stated that the data monitoring committee stopped the study after it met its primary endpoint, a composite of major and clinically relevant nonmajor bleeding, in participants taking abelacimab, a factor XI inhibitor, compared with patients taking rivaroxaban (Xarelto, Janssen/Bayer), a factor X inhibitor and a leading standard-of-care direct oral anticoagulant. The company noted that abelacimab is also the first and only factor XI inhibitor to demonstrate an unprecedented reduction in major bleeding compared with a DOAC.
“The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant,” Marc S. Sabatine, MD, MPH, the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine, Brigham and Women’s Hospital, professor at Harvard Medical School and chairman of the TIMI Study Group, said in the release. “With a median of 21 months of follow-up, spanning more than 2,000 patient-years, AZALEA-TIMI 71 represents a landmark study confirming the promise of factor XI inhibition as causing substantially less bleeding than a current standard-of-care.”
Abelacimab is a novel, highly selective, fully human monoclonal antibody with dual inhibitory activity against factor XI and its active form, factor XIa.
Abelacimab 150 mg maintains 98% inhibition over the dosing interval, recapitulating the benign bleeding profile of patients with genetic factor XI deficiency, according to the release. Prior to AZALEA-TIMI 71, abelacimab achieved an 80% reduction in venous thromboembolism compared with a standard-of-care comparator in a proof-of-concept efficacy study that was published in The New England Journal of Medicine.
“Given AZALEA-TIMI 71’s overwhelming reduction in bleeding, together with an 80% reduction in thrombosis demonstrated in our earlier VTE study, abelacimab embodies its promise as a hemostasis-sparing anticoagulant and represents a paradigm shift in the prevention of stroke and other thrombotic conditions,” Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics, said in the release. “If approved, more patients with atrial fibrillation could be treated effectively and safely, with a much lower risk of bleeding with abelacimab as compared to a DOAC.”
“Abelacimab has the potential to provide a game-changing treatment option for all those patients who live with the daily fear of bleeding while taking current anticoagulants,” Leslie Lake, president of the National Blood Clot Alliance, said in the release. “We can now imagine a future where these patients are able to resume and enjoy activities that they are currently being forced to give up due to concerns associated with bleeding. We are thrilled that AZALEA-TIMI 71 has demonstrated such a positive outcome and excited about the promise that it offers to patients.”
Anthos Therapeutics initiated an extension study to enable study participants to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile. As Healio previously reported, the FDA granted a fast track designation for abelacimab for the prevention of stroke and systemic embolism in adults with AF. The fast track designation is granted to therapies with the potential to fill unmet needs of patients with serious medical conditions.
The full results of AZALEA-TIMI 71 will be presented at an upcoming scientific congress, according to the release.
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