Neuralstem, Inc. (Amex: CUR) announced that the first subject was dosed yesterday in a Phase Ia trial to evaluate the safety of its drug, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications. NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform. This phase of the trial is in healthy volunteers and seeks to determine the maximum tolerated single dose.
"The initiation of clinical trial with our NSI-189 anti-depression program is a Neuralstem milestone," said Richard Garr, Neuralstem President & CEO. "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. We now have clinical trials in each of our two platforms, cell therapy and pharmaceuticals."
"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."
Major depressive disorder (MDD) (also known as recurrent depressive disorder, clinical depression, major depression, unipolar depression, or unipolar disorder) is a mood disorder characterized by an all-encompassing low mood, and by loss of interest and pleasure in activities that are normally enjoyable. MDD affects approximately 14.8 million American adults and is the leading cause of disability in the U.S. for ages 15-44, according to the National Institute of Mental Health.
Largest study using machine learning in neuroimaging sets new benchmark for major depression diagnosis