Swiss biopharmaceutical company Legacy Healthcare announced on Tuesday that it is planning to advance its topical solution, Cinainu, into a multi-regional Phase 3 trial (RAAINBOW-2) for moderate to severe alopecia areata (AA).

The US Food and Drug Administration (FDA) has cleared the company's IND filing for Cinainu, allowing the botanical drug-candidate to proceed with an international Phase 3 study in patients with moderate to severe AA for New Drug Application (NDA) purpose.

FDA clearance follows the successful international Phase 2/3 study (RAAINBOW) in children and adolescents with moderate-to-severe AA, and the agreement from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) on the conduct of a global Phase 3 trial including Japanese adult and paediatric patients (from age 2) to support registration in Japan. Discussions with other health authorities to extend the Phase 3 RAAINBOW-2 trial to additional regions will follow.