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.
PH94B is a first-in-class, odorless, rapid-onset (approximately 10 to 15 minutes) CNS neuroactive nasal spray with the potential to be the first FDA-approved, as-needed, on-demand treatment for millions of Americans who suffer from social anxiety disorder, with additional potential in peripartum anxiety, pre/postoperative anxiety, post-traumatic stress disorder, panic disorder and generalized anxiety disorder. Administered at microgram doses, PH94B activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social and work or performance situations. Following successful Phase 2 development, VistaGen is preparing for Phase 3 clinical development of PH94B for social anxiety disorder.
PH10 is a first-in-class, odorless, rapid-onset CNS neuroactive nasal spray in development for treatment of major depressive disorder. Administered in microgram doses, PH10 activates nasal chemosensory receptors that, in turn, engage neural circuits that lead to rapid antidepressant effects without psychological side effects, systemic exposure or safety concerns often associated with current oral antidepressants and ketamine-based therapies (intravenous ketamine or esketamine nasal spray). In an exploratory (n=30) randomized, double-blind, placebo-controlled Phase 2a clinical study in major depressive disorder, at microgram doses, rapid-onset antidepressant effects were observed and sustained for 8 weeks, without psychological side effects or systemic exposure. VistaGen is preparing for planned Phase 2b clinical development of PH10 for major depressive disorder.
AV-101 belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA (N-methyl-D-aspartate) receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist of the glycine co-agonist site of the NMDA receptor. AV-101 has potential to be a new at-home, non-sedating treatment for multiple large market CNS indications, including major depressive disorder, neuropathic pain, suicidal ideation, epilepsy and dyskinesia associated with levodopa therapy for Parkinson's disease.