BrainStorm Secures FDA Clearance to Launch Phase 3b Trial of NurOwn for ALS

May 19, 2025

DENVER, Colo., May 19, 2025 (247marketnews.com)- BrainStorm Cell Therapeutics (NASDAQ:BCLI) announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to begin its Phase 3b clinical trial of NurOwn (autologous MSC-NTF cells) for the treatment of amyotrophic lateral sclerosis (ALS).

Chaim Lebovits, President and CEO of BrainStorm, stated, “This FDA clearance is a defining milestone for BrainStorm and the ALS community. We are now positioned to swiftly activate clinical sites in a phased manner, diligently preparing to enroll the first patient in the Phase 3b trial. At the same time, we are actively working to secure funding through multiple avenues, including non-dilutive grants, to ensure the timely and successful launch of this critical study.”

The trial protocol was finalized under a Special Protocol Assessment (SPA) with the FDA, confirming that the study’s design, endpoints, and statistical methodology are appropriate to support a future Biologics License Application (BLA). This FDA clearance enables BrainStorm to move forward with patient enrollment.

The upcoming Phase 3b study will enroll approximately 200 participants across top-tier academic medical centers. The design includes a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension where all participants will receive NurOwn. The trial’s primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R). More details are available on ClinicalTrials.gov (ID: NCT06973629).

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