BrainStorm enters MOU with Pluri to support NurOwn trial

BrainStorm (BCLI) announced that it has entered into a memorandum of understanding, or MOU, with Pluri (PLUR) through its wholly owned subsidiary to manufacture NurOwn for use in BrainStorm’s planned Phase 3b trial in amyotrophic lateral sclerosis, or ALS. This MOU enables BrainStorm to begin transfer of its manufacturing technology and start producing NurOwn at Pluri’s manufacturing facility upon finalizing the binding definitive agreement. Under the terms of the proposed agreement, Pluri will provide GMP-compliant manufacturing of NurOwn at its facilities in Israel. This collaboration aims to fulfill essential supply requirements of NurOwn as BrainStorm advances its Phase 3b clinical trial. Additionally, the two companies are exploring options for manufacturing to support potential future commercial distribution, pending approval of NurOwn. The Phase 3b trial has been designed to enroll up to approximately 200 participants with ALS. It will be conducted in two parts: In Part A, participants will receive 3 doses of NurOwn or placebo for 24 weeks. This will be followed by an open label period, during which patients from both arms will receive 3 doses NurOwn for another 24 weeks. The primary efficacy endpoint will be a comparison of change in ALSFRS-R from baseline to week-24 for NurOwn vs. placebo. Successful completion of Part A of the double-blind Phase 3b study will position BrainStorm to submit a Biologics License Application, or BLA, for regulatory approval, potentially accelerating the path to market.