BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate its Phase 3b clinical trial of NurOwn® (autologous MSC-NTF cells) for the treatment of amyotrophic lateral sclerosis (ALS).
The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA), confirming the study’s endpoints and statistical methodology are appropriate to support a future Biologics License Application (BLA) submission. This clearance allows the company to proceed with patient enrollment.
The Phase 3b trial will enroll approximately 200 participants at leading academic medical centers and will consist of a 24-week randomized, double-blind, placebo-controlled phase followed by a 24-week open-label extension where all participants will receive NurOwn®. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R). For more details on the trial, refer to ClinicalTrials.gov ID NCT06973629.
