BrainStorm announces FDA SPA agreement for Phase 3b trial of NurOwn in ALS

BRAINSTORM CELL THERAPEUTICS INC.

FDA agreed on Phase 3b trial design under Special Protocol Assessment (SPA) for NurOwn in ALS.
Phase 3b trial (BCT-006-US) to enroll ~200 patients, double-blind placebo-controlled Part A (24 weeks) then open-label Part B.
Primary endpoint: change in ALSFRS-R total score at Week 24; CAFS to account for mortality.
Company expects trial commencement in 2024 after investigator and IRB approvals.
SPA validates protocol adequacy for supporting a future Biologics License Application (BLA).

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