Neuralstem NSI-189 Phase Ib Major Depression Disorder Neurogenic Biomarker Data Presented At The CNS Summit

Neuralstem, Inc. (NYSE MKT:

) announced that blood-based biomarkers for major depressive disorder (MDD) identified a rapid response to NSI-189 in the Phase Ib MDD trial. In the poster "Biomarker Profiling of NSI-189 Phosphate, a Neurogenic Compound, in Patients with Major Depressive Disorder (MDD) during a Phase Ib Randomized Double-Blind, Placebo-Controlled Trial," presented on Friday at the CNS Summit in Boca Raton, FL (http://www.cnssummit.org), researchers concluded that NSI-189 is rapidly and persistently efficacious. Furthermore, they suggest that it may be possible to predict a patient's response to the drug from baseline biomarker profiling. These results are consistent with clinical data results, reported at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in June, that showed a significant number of patients on active treatment demonstrated clinical improvement by a reduction in total Montgomery–Asberg Depression Rating Scale (MADRS) scores >/= 15.9 points, which continued 8 weeks after dosing stopped. This sustained drop was to a point at, or near, what is usually associated with remission on SSRI compounds. MADRS is a commonly-used clinical assessment scale to determine depression severity. NSI-189 is Neuralstem's first-in-class, lead neurogenic small molecule compound, shown to promote neurogenesis in vitro. In animal studies, NSI-189 resulted in a significant increase in hippocampal volume. Quantative EEG Phase Ib analysis, also reported in June, showed that active therapy patients had significantly increased brain wave patterns in the hippocampal region of the brain. "This is a small study, but we believe these established markers of depression, such as plasma levels of the stress hormone, cortisol, as well as neurotrophic factors, offer further biometric-based confirmation that NSI-189 appears to be demonstrating neurogenesis in the brain, as hypothesized and shown in animal studies," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. "There was little difference in baseline markers between control and active therapy patients at the beginning of the study. Upon commencing therapeutic dosing, a difference in depression biomarkers emerged between the groups within days and continued to improve through the 28-day treatment for the two lower-dose arms. Furthermore, during the non-dosing 8-week follow-up period, these two cohorts showed sustained benefits signaling sustained hippocampal neurogenesis." "NSI-189 is a novel neurogenic compound that has shown promise as a potential treatment for MDD in a Phase 1B, double-blind, randomized, placebo-controlled, multiple-dose study with three ascending cohorts," said study author and principal investigator in the Phase I trial, Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry and Executive Director, Clinical Trials Network and Institute, Massachusetts General Hospital. "Preliminary analysis of this small sample set suggests that prediction of response to NSI-189 may be possible from baseline peripheral biomarker profiling." "This data continues to validate the development of NSI-189 as a potentially new class of antidepressants that act via neurogenesis, a fundamentally different mechanism of action than current treatments, which have a low success rate," said Richard Garr, Neuralstem President and CEO. "We plan to launch a large, multi-site Phase II study in the second quarter of 2015.