Neuralstem reports additional Phase II data for NSI-189 in MDD

Neuralstem Inc. (NASDAQ:CUR) reported additional data from a Phase II trial of NSI-189 to treat major depressive disorder (MDD). In July, the company reported top-line data showing that both doses of NSI-189 missed the trial's primary endpoint of improving Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to week 12 vs. placebo (see BioCentury, July 28).

The double-blind, U.S. trial enrolled 220 patients to receive once- or twice-daily 40 mg NSI-189 or placebo for 6 weeks (Stage 1). After 6 weeks, non-responders in the placebo group (n=66) with an MADRS score of >15 points were re-randomized to receive either dose of NSI-189 or placebo for 6 weeks (Stage 2). Non-responders were defined as patients who achieved a <50% reduction in MADRS score. Stage 1 patients treated with NSI-189 continued treatment for an additional 6 weeks...