VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company committed to developing and commercializing new generation medications that go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders. Our pipeline includes three CNS product candidates, PH94B, PH10 and AV-101, each with a differentiated potential mechanism of action, favorable safety results observed in all clinical studies to date, and therapeutic potential in multiple CNS indications.
PH94B Nasal Spray
PH94B has the potential to be a first-in-class rapid-onset (within 15 minutes) nasal spray for use in a wide range of indications involving anxiety or phobia. Designed to be self-administered in microgram level doses, PH94B does not require systemic uptake and distribution to produce rapid-onset anti-anxiety effects and has demonstrated a favorable safety profile in all clinical studies to date. We are currently preparing PH94B for a pivotal Phase 3 clinical study as a potential acute treatment of anxiety in adults with social anxiety disorder (SAD). We are also planning for several small exploratory Phase 2A studies in adult patients experiencing adjustment disorder, pre-procedural anxiety, postpartum anxiety and post-traumatic stress disorder. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of PH94B for the acute treatment of SAD.
PH10 Nasal Spray
PH10 is an innovative investigational steroid nasal spray designed to have rapid-onset and therapeutic potential in several neuropsychiatric indications involving depression. Self-administered in microgram level doses, PH10 does not require systemic uptake and distribution to produce rapid-onset antidepressant effects. Following completion of a successful exploratory Phase 2A clinical study, we are preparing for a planned Phase 2B clinical study of PH10 as a new stand-alone treatment of MDD. With its rapid-onset pharmacology, potential lack of systemic exposure and favorable safety results observed in all clinical studies to date, we believe PH10 also has potential to be a new stand-alone treatment for several additional depression disorders.
AV-101, an Oral NMDAR Glycine Site Antagonist
AV-101 (4-Cl-KYN) is an investigational prodrug designed to be orally administered and to target the NMDAR (N-methyl-D-aspartate receptor), an ionotropic glutamate receptor in the brain. Abnormal NMDAR function is associated with numerous CNS diseases and disorders. AV-101’s active metabolite, 7-chloro-kynurenic acid (7-Cl-KYNA), has been observed to be a potent and selective full antagonist of the glycine co-agonist site of the NMDAR that inhibits the function of the NMDAR, but does not block NMDAR function like ketamine and other NMDAR antagonists. AV-101 has been observed in clinical trials to be orally bioavailable, well-tolerated and not cause dissociative or hallucinogenic psychological side effects or safety concerns similar to those that may be caused by other NMDAR antagonists. We are currently preparing to evaluate AV-101’s therapeutic potential in combination with probenecid in a Phase 1B clinical study. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for major depressive disorder and as a non-opioid treatment for neuropathic pain.