VistaGen Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, including major depressive disorder, neuropathic pain, social anxiety disorder and suicidal ideation.
AV-101 is an oral NMDAR GlyB (N-methyl-D-aspartate receptor glycine B) antagonist, belonging to a new generation of investigational medicines in neuropsychiatry known as glutamate receptor modulators having the potential to treat Major Depressive Disorder faster than currently available FDA-approved antidepressants which, if effective, take many weeks to months to achieve therapeutic benefits. With the at-home convenience of an oral therapy, AV-101 has the potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants.
PH94B was developed from proprietary compounds called pherines. With nasal spray administration, PH94B acts locally on peripheral nasal chemosensory receptors that trigger rapid activation of the hypothalamic-limbic areas of the brain associated with social anxiety disorder. This mechanism of pharmacological action, the rapid onset of efficacy, and the excellent safety and tolerability profile shown in clinical trials make PH94B an excellent product candidate for the acute treatment of patients with social anxiety disorder, which affects as many as 15 million adults in the U.S.
PH10, also developed from proprietary compounds called pherines, activates nasal chemosensory receptors that in turn engage GABA (gamma-aminobutyric acid) and CRH (corticotropin-releasing hormone) neurons in the limbic amygdala system. The activation of these neural circuits is believed to have the potential to lead to a rapid antidepressant effect. Ultra-low doses of intranasal PH10, with its novel mechanism of action, rapid onset activity and excellent safety and tolerability profile demonstrated in a phase 2a study, may represent another life-changing opportunity to address the growing unmet need among individuals suffering from MDD.