Neuralstem, Inc. (NYSE MKT: CUR) announced that it has begun dosing the second cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD). NSI-189, the lead compound in Neuralstem's neurogenic small molecule platform, is a proprietary new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD, as well as other diseases and conditions such as: chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
"We are pleased that the second cohort of depression patients has begun treatment," said Karl Johe , PhD, Chairman of the Board and Chief Scientific Officer of Neuralstem "There were no adverse, clinically significant findings in vital signs, respiration rate, pulse, body temperature readings, blood/urine tests, ECG, EEG, C-SSRS, or MRI in the first cohort. PK analysis showed the expected range of drug metabolism. In short, there were no surprises. The 40mg QD dose for 28 days was well-tolerated and safe. I expect the same from the next dose group, 40mg BID for 28 days. The efficacy data is, of course, blinded for all cohorts until the end of the trial."
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