This PIa trial will test a single oral administration of NSI-189. When the maximum tolerated single dose is determined, the trial will progress to the Ib phase, testing the safety of escalating doses of daily administration for 28 days in patients with major depressive disorder (NYSEARCA:MDD). The entire PI trial is expected to be approximately 1 year in duration.
- In mice, NSI-189 both stimulated neurogenesis of the hippocampus and increased its volume as well. Additionally, NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in vitro;
- This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the NIH.
The Bottom Line: This is the first-in-human administration of a new chemical entity of proprietary, oral drugs developed that stimulate the production of neurons. NSI-189 is the lead compound in CUR’s neurogenerative small molecule drug platform. CUR now has clinical trials in 2 platforms, cell therapy and pharmaceuticals. While current anti-depressant therapies seek to modulate symptomatic brain chemistry, NSI-189 stimulates new neuron growth and aims to restore fundamental brain physiology. NSI-189 may reverse the human hippocampal atrophy seen in major depression and other disorders.