Following the announcement of a major partnership, Pluri Inc. (NASDAQ: PLUR) saw a sharp spike in its stock price, rising 12.38% to $5.72. A significant advancement in the field of cellular therapeutics for neurodegenerative illnesses is this new collaboration, which was established through a Memorandum of Understanding (MOU) with BrainStorm Cell Therapeutics.
Collaboration to Help with the ALS Clinical Trial
Under the terms of this MOU, BrainStorm’s experimental treatment for ALS, NurOwn, will be produced by Pluri’s wholly owned subsidiary in preparation for an impending Phase 3b clinical study.
With the completion of a legally binding agreement, this arrangement enables BrainStorm to start transferring manufacturing technology to Pluri, opening the door for NurOwn’s manufacture in Pluri’s facilities. The arrangement also positions Pluri to provide Good Manufacturing Practice (GMP)-compliant production, adhering to stringent standards required for clinical trials.
Expanding Capabilities for Future Distribution
Pluri and BrainStorm aim to strengthen their partnership by exploring options for future commercial distribution of NurOwn, contingent upon regulatory approval. Pluri’s GMP-compliant facilities in Israel will not only support the Phase 3b trial but also provide critical infrastructure that could potentially meet the demands of broader commercial production.
The proximity of Pluri’s clinical manufacturing operations to BrainStorm’s research teams in Israel is anticipated to enhance communication and facilitate efficient collaboration.
Advanced Clinical Trial Targets ALS Treatment Breakthrough
The Phase 3b clinical trial is designed to assess NurOwn’s efficacy in treating ALS, enrolling up to 200 participants. Conducted in two phases, the trial includes an initial 24-week double-blind study (Part A), where patients receive either NurOwn or a placebo.
Following this, all participants will transition to an open-label phase (Part B) with further NurOwn doses. The main effectiveness metric will compare baseline and 24-week ALSFRS-R scores. BrainStorm may be able to file a Biologics License Application (BLA) for regulatory approval if this trial is successful.
Approaching a Possible Market Authorization
As the two businesses collaborate to develop a vital ALS cure, this partnership marks a strategic turning point for Pluri and BrainStorm. This collaboration has the potential to provide patients with ALS and other neurological illnesses much-needed hope by utilizing Pluri’s manufacturing experience and BrainStorm’s cutting-edge treatments.
