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Neuralstem Reports Last Subject Out in Phase 2 Trial of NSI-189 for Major Depressive DisorderGERMANTOWN, Md., May 17, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing next generation treatments for nervous system diseases, today announced it has completed dosing of the last subject in its multicenter Phase 2 clinical trial evaluating the efficacy of NSI-189 for the treatment of major depressive disorder (MDD). NSI-189 is an oral antidepressant with a novel mechanism of action and is the lead compound in Neuralstem's neurogenic small molecule program. “We believe that NSI-189 is a next generation treatment for MDD as it has the potential to promote remodeling of the hippocampus and reverse hippocampal atrophy, which has been linked to MDD pathology. Our goal is to further understand NSI-189’s role in MDD and believe that it may also have application in additional indications that affect cognition and/or neurodegeneration,” said Rich Daly, chairman and CEO, Neuralstem. “We look forward to unblinding the study data and analyzing the results. As previously announced, we anticipate that the top line data will be available in the third quarter of this year. We appreciate the enthusiasm of our investigators and commitment by the subjects, which has allowed the study to be completed approximately four months earlier than planned.” The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study in 220 subjects with MDD. Subjects were randomized and received 12-weeks of oral treatment with NSI-189 40 mg twice daily (BID), NSI-189 40 mg once daily (QD), or placebo in an outpatient setting. The primary efficacy endpoint is a reduction in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The study is 80% powered (p = 0.05) to show an improvement in depression symptoms, compared to placebo, with an effect size of d0.5. NSI-189: Neuralstem’s Lead Asset In a Phase 1B study in subjects with MDD, NSI-189 showed strong potential for efficacy on both depression and cognition scales. Results from the study also indicated that the compound may impart a durable effect. Data suggest that NSI-189 works by promoting synaptogenesis or neurogenesis in the hippocampus; a different mechanism of action than current marketed antidepressants. NSI-189 may have broad utility as a neuroregenerative drug. About Neuralstem Cautionary Statement Regarding Forward Looking Information Contact: Danielle Spangler Director of Investor Relations, Neuralstem 301-366-1481 [email protected] Kimberly Minarovich Argot Partners (Investor Relations) 212-600-1902 [email protected] Lori Rosen LDR Communications (Public Relations) 917-553-6808 [email protected] |