VistaGen, NIMH partner for Phase II trial of AV-101 to treat major depressive disorder

Under the deal, the two parties will collaborate on an NIH-sponsored Phase II trial of AV-101, VistaGen’s orally-active NMDA receptor modulator, in MDD patients.

MDD is a debilitating mental disorder that affects millions across the world, including nearly 7% of adults in the US.

NIMH chief of the Section on the Neurobiology and Treatment of Mood Disorders and chief of the Experimental Therapeutics and Pathophysiology Branch Dr Carlos Zarate will be the principal investigator of the NIH-funded trial, which is scheduled to be completed in 2015.

VistaGen president and CSO Ralph Snodgrass said: "Dr Zarate and his team have deep experience with ketamine and other NMDA receptor antagonists. We look forward to collaborating closely with them to complete this important AV-101 Phase II study in MDD by year end."

The randomized, double-blind, placebo-controlled, crossover trial is designed to evaluate the efficacy and safety of a single oral dose of AV-101 administered once per day for 14 days to approximately 25 subjects with MDD.

The trial’s primary efficacy measure will be the Hamilton Depression Rating Scale (HDRS), a standard scale for measuring depression severity.

AV-101 is an orally-active, prodrug candidate that produces, in the brain, 7-chlorokynurenic acid (7-Cl-KYNA), one of the most potent and selective antagonists of the glycine-binding site of the NMDA receptor, resulting in the down-regulation of NMDA signaling.

The company said that similar to Ketamine, AV-101 has a fundamentally new mechanism of action compared to all approved antidepressants.