Rockville, Md. — Neuralstem, Inc. has announced that the first subject has been was dosed in a Phase Ia trial to evaluate the safety of the company's drug, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications.
The lead compound in Neuralstem's neurogenerative small molecule drug platform, NS-189 is the first in a class of compounds that Neuralstem plans to develop into orally administered drugs for MDD and other psychiatric disorders.
This phase of the clinical trial with the NSI-189 anti-depression program is in healthy volunteers and seeks to determine the maximum tolerated single dose. According to Neuralstem president and CEO Richard Garr, the trial is a milestone for the company.
"This is the first-in-human administration of our new chemical entity of proprietary, oral drugs discovered and developed in-house that stimulate the production of neurons," said Garr. "We now have clinical trials in each of our two platforms, cell therapy and pharmaceuticals."
In mice, NSI-189 both stimulated neurogenesis of the hippocampus and increased its volume as well, according to the comapny. Additionally, NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in vitro. Therefore, Neuralstem contends that NSI-189 may reverse the human hippocampal atrophy seen in major depression and other disorders.
The program also has received support from the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).
"While current antidepressant therapies seek to modulate symptomatic brain chemistry, NSI-189 stimulates new neuron growth and aims to restore fundamental brain physiology," said Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "It has the potential to directly address the pathology of the disease itself, potentially reversing the hippocampal atrophy associated with depression and other disorders."
The Phase Ia trial will test a single oral administration of NSI-189 in healthy volunteers. When the maximum tolerated single dose is determined, it will progress to the Ib phase, testing the safety of escalating doses of daily administration for 28 days in patients with major depressive disorder (MDD).
The entire Phase I trial is expected to last approximately one year.