Neuralstem Explodes on Positive Phase 2 Clinical Data

Shares of Neuralstem were exploding in Tuesday trading and closed the day up 175% after revealing successful updated Phase 2 clinical data in its depressive disorder trial of NSI-189.

The results were presented at the 56th American College of Neuropsychopharmacology (ACNP) Annual meeting in a poster presentation entitled, “A Phase 2, Double-Blind, Placebo-Controlled Study of NSI-189 Phosphate, a Neurogenic Compound, Among Out-Patients with Major Depressive Disorder.”

Maurizio Fava, MD, the lead investigator of the trial remarked, “NSI-189 appears to be a broad-acting antidepressant, with effects in both core symptoms of depression and in aspects of cognition where standard antidepressants typically show very modest effects. These results warrant the continued study of this compound among MDD patients who are inadequately managed by current antidepressant therapies.”

As per the company’s press release, “Phase 2 trial, 220 subjects were randomized to: NSI-189 40mg daily (n=44), NSI-189 80mg daily (n=44), or placebo (n=132) for 6 weeks (Stage 1). At the end of 6 weeks, placebo-treated subjects who were non-responders (defined as less than 50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS)) with a MADRS score greater than 15 were re-randomized to 6 weeks treatment with NSI-189 40 mg daily (n=22), NSI-189 80 mg daily (n=22), or placebo (n=22) (Stage 2). Patients on NSI-189 who completed Stage 1 continued the same dose for another 6 weeks.”

Disclaimer: We have no position in Neuralstem, Inc. (NASDAQ: CUR) and have not been compensated for this article.