Neuralstem (CUR) Surpasses 50% Enrollment Mark in Phase 2 MDD Study

September 21, 2016 8:35 AM EDT

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Neuralstem, Inc. (Nasdaq: CUR) announced that it has reached over 50% enrollment in its Phase 2 clinical trial evaluating NSI-189, a novel neurogenic small molecule, for the treatment of major depressive disorder (MDD).

The ongoing Phase 2 MDD study is testing two doses (40mg QD and 40mg BID) of NSI-189, a small molecule in an oral tablet formulation. The multi-center, double-blind, placebo-controlled Phase 2 study plans to enroll a total of 220 moderately depressed patients at 12 trial sites. The primary efficacy endpoint is a reduction in depression symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary endpoints include additional clinical outcomes and cognition improvement measures. The study duration is for 12 weeks, with a separate observational study to monitor the responders for six months in order to assess NSI-189’s potential durability of benefits. The overall study principal investigator (PI) is Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry and Executive Director, Clinical Trials Network and Institute, Massachusetts General Hospital. More information about the trial is available at www.clinicaltrials.gov (NCT02695472).

“We are very pleased to have reached the halfway milestone in our Phase 2 MDD trial ahead of schedule and remain confident that we will provide study results in the second half of 2017,” said Rich Daly, CEO. “Moreover, NSI-189 has been shown to be safe thus far and may provide patients an alternative to current commercialized therapies.”

NSI-189, the lead compound in Neuralstem’s neurogenic small molecule program, is a proprietary, new chemical compound that stimulates neurogenesis, synaptogenesis and increases hippocampal volume, all of which are believed to be effective in reversing depression, enhancing cognition, and promoting neuroregeneration. Neuralstem recently reported in vitro data showing that mouse hippocampal slices treated with NSI-189 produced a time- and concentration-dependent enhancement of both short-term potentiation (STP) and long-term potentiation (LTP). LTP and STP refer to strengthened communication between neurons and key components of synaptic plasticity, which play critical roles in memory formation and cognition.



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