Neuralstem, Inc. (NASDAQ:CUR) reported that additional safety, tolerability and efficacy data from its exploratory Phase II clinical study assessing the efficacy of NSI-189 at 40 mg QD and 40 mg BID versus placebo for the treatment of MDD were showcased at the 56th ACNP Annual Meeting. These additional results indicate that NSI-189 boasts antidepressant effects with cognitive advantages shown on both subjective and objective measures.
Maurizio Fava, MD, the Principal Investigator of the Trial, stated that NSI-189 seems to be a broad-acting antidepressant. It has effects in both core indications of depression and in parts of cognition where standard antidepressants usually exhibit extremely modest effects. This report warrants the continued trial of this compound among MDD subjects who are inadequately managed by existing antidepressant therapies.
Rich Daly, the CEO and Chairman of Neuralstem, expressed that they are extremely delighted that the novel, neurotrophic, neurogenic mechanism of action of “NSI-189” has demonstrated both pro-cognitive and antidepressant activity in depressed subjects, and which seems to result in substantial benefit as reported by the patients themselves as well as by objective computerized measurements. The report further support data from the initial Phase 1b in patients with MDD, which showed potential efficacy on both cognition and depression scales.
The CEO of Neuralstem added that they look forward to meeting with the U.S. FDA in 1H2018 to further define the clinical advancement and regulatory paths for NSI-189. They also intend to submit the data of this trial to a peer reviewed publication by the close of this year.
Following the promising data, the stock price of Neuralstem in yesterday’s trading session jumped more than 175% to close the day at $3.09. The gains came at a share volume of 55.63 million compared to average share volume of 231,905. After the recent jump, the market cap of firm was noted at $46.80 million.