VistaGen Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel medicines for the treatment of disorders involving the central nervous system (CNS). The Company’s lead product candidate, AV-101, is a next generation depression therapy with strong safety and an emerging efficacy profile addressing significant shortcomings of standard antidepressants. AV-101 is an orally-available NMDA receptor (NMDAR) glycine-binding (GlyB) site antagonist that has been shown to provide ketamine-like antidepressant effects without the undesired side effects.
AV-101 is currently being evaluated in an NIMH-sponsored Phase 2a study for treatment-resistant major depressive disorder (MDD) with results expected in the second quarter of 2017. VistaGen is also planning to initiate a potentially pivotal Phase 2b study of AV-101 for the treatment of MDD in the fourth quarter of 2016. Based on preclinical studies, AV-101 also has the potential to address multiple neuropsychiatric, neurological and neurodegenerative diseases, including bipolar disorder, chronic neuropathic pain, epilepsy, Huntington’s disease and Parkinson’s disease.
The Principal Investigator of our ongoing Phase 2a clinical study of AV-101 in MDD is Dr. Carlos Zarate, Jr., Chief of the NIMH’s Experimental Therapeutics & Pathophysiology Branch and Section on Neurobiology and Treatment of Mood and Anxiety Disorders. Dr. Zarate previously conducted NIMH studies focused on the antidepressant effects of intravenous (I.V.) ketamine. These studies demonstrated robust antidepressant effects in patients with treatment-resistant MDD within hours of a single low dose of I.V. ketamine and catalyzed R&D around a new generation of antidepressants with potential to deliver ketamine-like fast-onset benefits without its side effects.
In addition to AV-101, we have also developed a human pluripotent stem cell (hPSC) technology platform, which includes our customized in-vitro bioassay system, CardioSafe 3D™, to predict potential heart toxicity of new chemical entities (NCEs) long before testing in animal and human studies. We are currently evaluating potential strategic collaborative opportunities to further develop and commercialize our stem cell technology platform, emphasizing NCE drug rescue and regenerative medicine involving multiple cell types.