would like to highlight VistaGen Therapeutics, Inc.
), a clinical-stage biopharmaceutical company focused on applying proprietary human pluripotent stem cell technology for drug rescue and cell therapy. Its Human Clinical Trials in a Test Tube is a pluripotent stem cell technology platform for predictive toxicology, drug development, and drug rescue.
In the company’s news:
VistaGen Therapeutics is currently collaborating with Dr. Carlos Zarate and the U.S. National Institutes Health (NIH) on an NIH-funded Phase 2 clinical study of its new drug candidate, AV-101, for the treatment of major depressive disorder (MDD).
Another drug, ketamine, has shown potential for treating patients suffering from MDD. Unfortunately, its prospects for widespread therapeutic use are limited because of its high potential for abuse, dissociative and psychosis-like side effects, and required intravenous administration in a medical center.
The industry is buzzing about AV-101, which is orally-active, because it may rapid-acting antidepressant benefits that are extremely similar to intravenous ketamine, without ketamine’s limiting side effects. “We are excited by the strong preclinical efficacy data supporting the ketamine-like antidepressant effects of AV-101, as well as the rapid and efficient oral-delivery and clinical safety range demonstrated by our successful Phase I clinical studies,” said H. Ralph Snodgrass, President and CSO of VistaGen. The company expects to complete its Phase 2 study by the end of this year.
While current MDD medications are part of a multi-billion dollar global antidepressant market, the available treatments have limited effectiveness in many cases. Although two out of three patients eventually find a drug combination that induces remission of their depression symptoms, the trial and error process that is presently in use is known to increase the risks of patient tolerability issues and serious side effects. Sadly, as many as 15 percent of individuals suffering with MDD commit suicide as a result.
AV-101’s mechanism of action is fundamentally different compared to current MDD medications. AV-101 works by modulating NMDA receptor channel activity by selectively binding to, and blocking, the glycine-binding co-agonist site of the NMDA receptor. By targeting the glycine-binding co-agonist site, the company’s drug candidate can bypass the adverse effects associated with ketamine without eliminating its surge of glutamate, which provides a powerful antidepressant effect to the patient. VistaGen’s AV-101 could prove to be the perfect solution to correct the flaws in the current treatment process.
MDD is a widespread and debilitating mental disorder affecting nearly 7 percent of U.S. adults. VistaGen, through its AV-101, could be on the brink of a breakthrough for MDD patients who do not benefit from existing antidepressants.
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