VistaGen Therapeutics (NASDAQ:VTGN) initiates ELEVATE, the Company's 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 FDA.
The study will enroll ~180 patients. The primary endpoint is the change from baseline as measured by the Montgomery-Asberg Depression Rating Scale. Top-line results are expected in H1 2019.
AV-101 is an oral N-methyl-D-aspartate receptor glycine B (GlyB) antagonist in Phase 2 clinical development in the U.S., as a new adjunctive treatment of MDD.
Shares are up 12% premarket.
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