VistaGen Therapeutics, Inc. (Nasdaq: VTGN), is a clinical-stage biopharmaceutical company developing new generation medicines for depression and other CNS diseases and disorders. VistaGen's lead CNS product candidate, AV-101, an oral N-methyl-D-aspartate receptor glycine B (NMDAR GlyB) antagonist, belongs 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's mechanism of action is fundamentally different from all SSRIs and SNRIs, as well as atypical antipsychotics often used adjunctively to augment them.
ELEVATE is VistaGen’s ongoing Phase 2, randomized, double-blind, multi-center, placebo-controlled clinical trial designed to evaluate the efficacy and safety of adjunctive use of oral AV-101 for MDD in patients with an inadequate response to standard antidepressant therapy with either an FDA-approved SSRI or SNRI. Approximately 180 patients will be randomized to receive either AV-101 or placebo, orally, once daily, in conjunction with their ongoing antidepressant, for fourteen days. The primary endpoint of the study is the change from baseline as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Dr. Maurizio Fava of Massachusetts General Hospital and Harvard Medical School is the Principal Investigator of the study.
In addition to VistaGen’s ELEVATE study, the U.S. National Institute of Mental Health (NIMH) is evaluating AV-101 in a Phase 2 monotherapy study for the treatment of MDD with 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 as the principal investigator. The study is being fully funded and conducted by the NIMH.
VistaGen's orally available AV-101 may also have potential in conjunction with ketamine treatment for MDD and suicidal ideation, as a non-sedating, non-opioid alternative to treat neuropathic pain and epilepsy, to reduce dyskinesia associated with Huntington's disease and levodopa therapy for Parkinson's disease (PD LID), and for other CNS diseases and disorders where modulation of the NMDA receptors and activation of AMPA receptors may achieve therapeutic benefits.
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