SOUTH SAN FRANCISCO & MOUNTAIN VIEW, Calif.—VistaGen Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing a new generation of medicines for depression and other central nervous system (CNS) diseases and disorders with high unmet need, and Pherin Pharmaceuticals Inc., a biopharmaceutical company focused on development of novel treatments for neuropsychiatric and neuroendocrine conditions, have announced the signing of a license agreement granting VistaGen exclusive worldwide rights to develop and commercialize PH94B nasal spray, a Phase 3-ready drug candidate for as-needed (PRN) treatment of social anxiety disorder (SAD).
“SAD affects nearly 15 million Americans. Currently, there is no FDA-approved treatment that provides rapid-acting relief, and sedatives used off-label carry with them the risk of addiction and other significant side effects and safety concerns,” noted Shawn Singh, CEO of VistaGen. “PH94B clinical data are compelling and support its potential to be a first-in-class, rapid-acting, self-administered PRN treatment alternative, without sedation, risk of addiction or other safety concerns, for millions affected by SAD in the U.S. and other major markets.
“This transaction not only expands and diversifies our CNS pipeline to include SAD, but also firmly complements our patent-protected, neuropsychiatry focus on MDD with AV-101 in our ongoing Phase 2 ELEVATE Study ... Our key objective for the PH94B program is to commence our initial pivotal Phase 3 clinical trial of PH94B nasal spray for SAD during the first half of 2019.”
Pherin’s first-in-class proprietary compounds called “pherines” are synthetic neuroactive steroids that engage nasal chemosensory receptors which, in turn, inhibit nerve circuits mediating behavioral and physiological effects of anxiety.