The U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug application to initiate a Phase Ia safety trial to test NSI-189, a proprietary new chemical entity discovered by Neuralstem, Inc. According to the company, NSI-189 could stimulate new neuron growth in the hippocampus and reverse hippocampal atrophy seen in major depression, as well as provide potential treatments for other diseases such as schizophrenia and Alzheimers.
"The commencement of the first trial in our small molecule platform represents a major milestone for Neuralstem," said Neuralstem president and CEO Richard Garr. "In addition to our ongoing programs in cell therapeutics, we are now advancing a new class of orally administered drugs that recruit endogenous neural stem cells."
Antidepressants are currently based on a theory of serotonin deficiency, however a new theory is emerging that chronic stress can lead to hippocampal atrophy and eventually to depression, according to Karl Johe, PhD, Neuralstem's Chief Scientific Officer and chairman of the Board of Directors. "NSI-189 appears to help the brain repair itself, generating new neurons and protecting against damage. This neurogenic approach is completely novel in the treatment of CNS diseases," Johe explained.
NS-189 is the first in a class of compounds that Neuralstem plans to develop into orally administered drugs. This Phase Ia trial will test a single dose of NSI-189 in healthy patients. If the safety endpoints are met, 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.