BrainStorm reports ‘productive’ meeting with FDA to discuss NurOwn

BrainStorm Cell Therapeutics announced the completion of a productive meeting with the U.S. FDA to discuss NurOwn, its investigational treatment for amyotrophic lateral sclerosis. The primary objective of the meeting was to discuss key considerations for a Special Protocol Assessment for a planned Phase 3b registrational trial for NurOwn. As an outcome of the meeting, BrainStorm will submit relevant documentation as outlined by the FDA to support the SPA. The ultimate goal is to secure the FDA’s agreement that critical elements of the overall protocol design are adequate and acceptable for a study intended to support a future marketing application. “Our meeting with the FDA provided us with valuable input on the Phase 3b trial design, outlining clear steps forward,” said Chaim Lebovits, President and CEO of BrainStorm. “We believe that a SPA will serve to help de-risk certain regulatory aspects of the NurOwn clinical program. We recognize the urgency in providing ALS patients with safe and efficacious treatments and are committed to agreeing on a regulatory path forward for NurOwn. We are grateful for the FDA’s continued support and guidance and look forward to providing further updates once we have more clarity on an SPA.”