VistaGen Therapeutics (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company focused on developing new generation therapies for depression and other central nervous system (CNS) disorders. VistaGen’s lead CNS product candidate, AV-101, is an orally available prodrug in Phase 2 development, initially for the adjunctive treatment of major depressive disorder (MDD) in patients with inadequate response to standard FDA-approved antidepressants. AV-101 has the potential to be faster-acting and safer than standard FDA-approved antidepressants, as well as atypical antipsychotics commonly used adjunctively to augment them. AV-101 is a NMDA receptor glycine-binding (Glyв) site antagonist and has been shown in published preclinical studies to provide fast-acting, ketamine-like, antidepressant effects without serious CNS side effects typically associated with ketamine and FDA-approved drug therapies for depression.
AV-101 is being evaluated in an ongoing Phase 2 monotherapy study in MDD, a study being conducted at the U.S. National Institute of Mental Health (NIMH) and being funded by the NIMH, with topline results anticipated in the first half of 2018. VistaGen is also preparing to launch a Phase 2 study of AV-101 in the first half of 2018 for the adjunctive treatment of MDD.