VistaGen Therapeutics Initiates Phase 2 Study of AV-101 for Major Depressive Disorder

VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for depression and other central nervous system (CNS) disorders, today announced the initiation of ELEVATE, the Company’s double-blind, placebo-controlled Phase 2 clinical study to evaluate the efficacy and safety of AV-101 (L-4-chlorokynurenine) as an adjunctive treatment of Major Depressive Disorder (MDD) in patients with an inadequate response to current antidepressants approved by the U.S. Food and Drug Administration (FDA).

As quoted in the press release:

AV-101, an oral N-methyl-D-aspartate (NMDA) receptor glycine B (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.

“Major Depressive Disorder is one of the most common diseases affecting the U.S. population and many patients who suffer from it do not respond adequately to currently available treatments,” said Professor Maurizio Fava, M.D., Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital (MGH) and Associate Dean for Clinical & Translational Research, Harvard Medical School. “This is an important clinical study given the properties of AV-101. By studying AV-101, with its ability to be orally available and to inhibit glutamatergic NMDA receptor activity through GlyB site binding, we hope to improve clinical outcomes in depressed patients with an inadequate response to standard antidepressant therapies.”

Click here to read the full press release.