Neuralstem has completed phase Ia in the ongoing safety trial to test its neuroregenerative small molecule drug, NSI-189, in the treatment of major depressive disorder (MDD). Phase Ia tested the drug in healthy volunteers for safety and tolerability. Phase Ib, which the company expects to commence later this year, will test the safety and tolerability of NSI-189 in depressed patients.
NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in MDD and other diseases and conditions, such as Alzheimer's disease and PTSD.
This phase Ia trial tested single ascending doses of NSI-189 in healthy patients. Standard safety endpoints were monitored. All doses were well tolerated and there were no drug-related serious adverse events. The trial will commence to the Ib phase, testing the safety of escalating doses of daily administration for 28 days in depressed patients. The entire phase I trial is expected to be approximately one year in duration.
NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform, which the company plans to develop into orally administered drugs for major depression and other psychiatric disorders.