BrainStorm Cell Therapeutics (BCLI) said Monday the US Food and Drug Administration has authorized the company to launch a phase 3b clinical trial of NurOwn for treating amyotrophic lateral sclerosis.
The study design, including endpoints and statistical methods, was finalized with the FDA under a special protocol assessment, the company said.
The trial will enroll about 200 patients in a randomized, placebo-controlled phase followed by an open-label extension in which all participants receive NurOwn, BrainStorm said.
The primary outcome is the change from baseline at 24 weeks on the ALS Functional Rating Scale-Revised, it added.
BrainStorm also said it is preparing trial sites and seeking additional funding, including non-dilutive grants, to support the launch.
Shares of the company were up over 38% in recent Monday premarket activity.
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