Research & Development
Recursion wins US FDA's clearance to initiate first clinical trial of REC-994 in cerebral cavernous malformation
12 July 2018 -

Biotechnology company Recursion disclosed on Wednesday that it has passed the US Food and Drug Administration's (FDA) clearance for an investigational new drug (IND) application for a Phase 1 clinical trial of REC-994 in the treatment of cerebral cavernous malformation (CCM).

The Cerebral cavernous malformations (CCMs) are collections of small blood vessels in the brain that are enlarged and irregular in structure, which lead to altered blood flow and cause severe symptoms, including seizures, vision and hearing loss, paralysis, other focal neurologic deficits and/or hemorrhagic stroke.

The company added REC-994 is a well-characterised, small molecule that has been granted orphan designation by the US FDA for symptomatic CCM and by the European Medicines Agency for familial CCM. REC-994 is a potent, selective superoxide dismutase mimetic, a mechanism of action that has preclinical proof of concept to impact lesion development in a mouse model of CCM.

In conjunction, the company intends to launch the first clinical trial to evaluate the safety and pharmacokinetics of REC-994 as an oral treatment for CCM.