VistaGen Therapeutics, Inc. (Nasdaq: VTGN), is a clinical-stage biopharmaceutical company developing new generation medicines for depression and other central nervous system (CNS) diseases and disorders. Our lead CNS product candidate, AV-101, is an oral N-methyl-D-aspartate receptor glycine B (NMDAR GlyB) antagonist, belonging to a new generation of investigational medicines in neuropsychiatry known as glutamate receptor modulators having the potential to treat MDD faster than current FDA-approved antidepressants commonly known as SSRIs and SNRIs, which target the neurotransmitters serotonin and/or norepinephrine, respectively. AV-101 has a novel mechanism of action (MOA), meaning its MOA is fundamentally different from all current FDA-approved SSRIs and SNRIs for depression, most of which, if effective, take many weeks to achieve therapeutic benefits. AV-101 has the potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants.
AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a Phase 2 monotherapy study in MDD. The study is being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH, and one of the world's foremost experts on the use of low dose IV ketamine and other NMDA receptor antagonists to treat MDD. VistaGen also launched ELEVATE, a 180-patient Phase 2 study of AV-101 as an adjunctive treatment of MDD in patients with inadequate response to current FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University is the Principal Investigator of the Phase 2 adjunctive treatment study.
AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, Parkinson’s disease levodopa-induced dyskinesia (PD LID) and other diseases and disorders where modulation of NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.
In addition to our AV-101 programs, VistaStem Therapeutics, VistaGen's wholly-owned subsidiary, is focused on applying stem cell technology to develop and commercialize proprietary new chemical entities (NCEs) for VistaGen’s CNS pipeline and out-licensing, as well as cellular and regenerative therapies for a range of diseases and disorders involving blood and bone marrow cells, chondrocytes and cartilage, and heart and liver cells, including autoimmune disorders, cancer, heart and liver disease, osteoarthritis and joint injury.