VistaGen Therapeutics was founded in the late 1990s by a team of scientists believing that better cells lead to better medicine. In the years since, this California-based clinical-stage biopharmaceutical company also has focused on developing groundbreaking medicine for depression and other diseases and conditions involving the central nervous system.
VistaGen continues to expand the scope of its pipeline opportunities, employing its world-class biopharma expertise to gain a unique position that allows it to pursue potentially valuable research and clinical development collaborations. Last month, VistaGen revealed that it had signed a valuable Cooperative Research and Development Agreement, or CRADA, with the U.S. National Institute of Mental Health (NIMH), a division of the prestigious U.S. National Institutes of Health (NIH). Under the new agreement, the NIMH and VistaGen will collaborate on a fully-NIH-sponsored phase 2 efficacy study of AV-101, the company’s orally-active NMDA receptor modulator for the treatment of major depressive disorder (MDD).
Like ketamine, an anesthetic receiving a lot of attention for its potential to treat MDD, AV-101 has a fundamentally novel mechanism of action compared to all FDA-approved antidepressants and will be studied in subjects with MDD, a far-reaching and devastating mental disorder affecting millions of people around the globe. AV-101 differs from ketamine, however, in that, in VistaGen’s NIH-funded phase 1 clinical studies, it produced no ketamine-like psychotic side effects and it can be orally administered (ketamine is administered intravenously).
The NIH-sponsored Phase 2 clinical trial will be a crossover study conducted at the NIH and designed to assess the effectiveness and safety of a single oral dose of AV-101 administered once a day for 14 days to approximately 25 subjects with MDD. The study will be randomized, double-blind and placebo-controlled, and the primary measure of effectiveness will be a standard scale for measuring depression severity, the Hamilton Depression Rating Scale. VistaGen and the NIH expect to announce the results of the study near the end of 2015.
Dr. Carlos Zarate, Chief of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the NIMH, will be the study’s chief investigator. Dr. Zarate and his team have extensive clinical experience with ketamine and other NMDA receptor modulators.
The VistaGen team is clearly excited by the strong preclinical efficacy data supporting the potential antidepressant effects of AV-101 similar to the results reported in NIH studies involving ketamine, as well as the efficient oral-delivery and clinical safety range demonstrated by its successful phase 1 clinical studies. The group looks forward to collaborating closely with Dr. Zarate’s team to complete this important AV-101 Phase 2 study in MDD by year end.
Based on preclinical studies, AV-101 may also serve as a potential treatment for other CNS-related conditions such as chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases such as Parkinson’s disease and Huntington’s disease.
For more information, visit www.vistagen.com
