Anthos mid-stage trial stopped early due to "overwhelming" effect

 A novel antibody developed by Anthos Therapeutics, a cardiovascular specialist founded by Blackstone Life Sciences, has performed well in a Phase II trial.

Abelacimab is a novel monoclonal antibody under development for people with atrial fibrillation. The therapy locks Factor XI in the inactive state, resulting in dual inhibitory activity.

Scientists at the company believe this approach may provide an effective treatment strategy for a certain group of people who can benefit from the protection of an anticoagulant.

Encouraging data

Results show that the mid-stage AZALEA-TIMI 71 trial, which has enrolled over 1,200 patients with atrial fibrillation at moderate-to-high risk of stroke, met its primary endpoint at an interim analysis.

The firm said data monitors had advised to stop the trial early, “due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban,” a leading standard-of-care direct oral anticoagulant.

The data make abelacimab the first and only Factor XI inhibitor to show this level of reduction in major bleeding compared to a direct oral anticoagulant (DOAC).

Chief medical officer Dan Bloomfield said: “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.”

He added: “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.”

In the USA, the candidate has been granted a Fast-Track designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Full results from the trial will be presented at an upcoming scientific congress.

https://www.thepharmaletter.com/article/mid-stage-trial-stopped-early-due-to-overwhelming-effect