Baylor College of Medicine is collaborating with VistaGen Therapeutics, Inc. on a study of the anti-suicidal effects of a new VistaGen drug candidate in healthy veteran volunteers.

“The suicide rate is two times higher in veterans than in age- and sex-matched civilians,” said Dr. Marijn Lijffijt, assistant professor in the Menninger Department of Psychiatry and Behavioral Sciences and at the Michael E. DeBakey VA Medical Center, and principal investigator of the study. “A priority for suicide prevention is to come up with novel treatment targets for safe and rapidly acting interventions to impact acute suicidality, which is not adequately addressed with current treatments.”

The drug candidate, AV-101, is an oral, non-opioid, non-sedating NMDA receptor glycine B (NMDAR GlyB) antagonist.

A total of 12 healthy veteran volunteers from either Operation Enduring Freedom, Operation Iraqi Freedom or Operation New Dawn will be given single doses of AV-101 at two different doses, 720 mg and 1440 mg, and a placebo over three weeks to define a dose-response relationship between exposure to the drug and relevant neurophysiological markers that reflect brain functions previously associated with suicidality.

This study is the first step in working to revolutionize the way that we treat suicidal ideation and suicidal behaviors, Lijffijt said. The goal is to complete the dosing by the end of September 2018, with top-line results from the study expected by year end. The results of this initial study in healthy veteran volunteers could lead to a Phase 2 study involving AV-101 and veterans who are battling suicidal ideation or suicidal behaviors.

“The number of veterans who take their own lives is tragic and staggering, averaging 20 suicides per day. These statistics are not acceptable,” said Shawn Singh, VistaGen CEO. “As suicide prevention is a vital mission of Baylor and VistaGen, our common goal for this initial study is to set the stage to advance our collective efforts to help veterans counteract suicidal ideation on a long-term basis. The bottom line is that suicide is a national public health concern that affects people everywhere, and we must do more to raise awareness and pursue fast-acting, safe and novel treatments to help those who continue to suffer from both debilitating depression and suicidal ideation.”

VistaGen and the U.S. Department of Veterans Affairs entered into a Material Transfer Cooperative Research and Development Agreement for this study, for which government funding will be provided.