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news.The US Food and Drug Administration (FDA) has given approval to Neuralstem to advance its novel neuroregenerative compound, NSI-189, to Phase Ib in its ongoing clinical trial as a treatment of major depressive disorder (MDD).
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NSI-189 is the lead compound in Neuralstem’s neuroregenerative small molecule drug platform, indicated to treat psychiatric disorders such as Alzheimer’s disease, anxiety, bipolar disorder and post traumatic stress disorder.
The NSI-189/MDD trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of MDD.
Phase Ib will test the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients.
Phase Ia tested escalating doses of single administration of NSI-189 in healthy patients.