Therapy Areas: Cardiovascular
Anthos Therapeutics' abelacimab receives US FDA Fast Track Designation
12 July 2022 -

Anthos Therapeutics, a US-based clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced on Monday that it has received Fast Track Designation from the United States Food and Drug Administration (FDA) for its investigational Factor XI inhibitor, abelacimab intended to treat thrombosis associated with cancer.

Dan Bloomfield, Anthos Therapeutics' chief medical officer, said, 'We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents. This unmet need is particularly true in patients with gastrointestinal / genitourinary (GI/GU) cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections. Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients. We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need.'

Abelacimab is a novel, highly selective, fully human monoclonal antibody aimed at inducing effective haemostasis-sparing anticoagulation via Factor XI inhibition. It is aimed at the active domain of Factor XI, showcasing dual inhibitory activity against both Factor XI and its activated form, Factor XIa. It can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then utilised subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting.



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