VistaGen Therapeutics Acquires Worldwide License of Phase 3-Ready CNS Drug Candidate

VistaGen Therapeutics, Inc. and Pherin Pharmaceuticals, Inc. recently 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.  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,” said Shawn Singh, Chief Executive Officer of VistaGen. “We are excited to be working with Pherin’s innovative team to develop and commercialize this medically and socially impactful treatment. 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. This mechanism of action, the rapid onset of efficacy, and the excellent safety and tolerability profile shown in multiple previous clinical trials, including a pilot Phase 3 feasibility study for evaluating the safety and efficacy of PH94B, make PH94B a novel product candidate for the acute, intermittent and long-term treatment of individuals with SAD.

Dr. Louis Monti, Executive Vice President of Pherin, stated “This agreement provides a meaningful opportunity to continue our clinical progress and advance our mission to bring novel treatment alternatives to the many individuals affected with SAD. We are confident VistaGen will build upon our earlier clinical studies, which provided impressive evidence of rapid (10-15 minutes) anxiety reduction for subjects with SAD. In all prior clinical studies, PH94B was well tolerated and there were no adverse events associated with nasal spray administration. Our prior clinical studies support the potential of PH94B to be a superior treatment alternative for SAD due to the demonstrated rapid onset of efficacy, route of administration, as-needed dosing convenience, and excellent safety profile compared to other existing therapeutic options which require chronic dosing and have concurrent side effects.”

An estimated 12.1% of US adults experience SAD at some time in their lives.¹ SAD is characterized by excessive anxiety about scrutiny or evaluation by others that leads an individual to avoid social situations and/or performance.² SAD affects social, academic and work life, and often presents with other anxiety disorders, MDD and substance use disorders, and the onset of SAD generally precedes that of other disorders.³ Currently, selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake inhibitors (SNRIs) are FDA-approved for treatment of SAD, but they take weeks to months to work, must be taken chronically and present numerous side effects.

VistaGen has also acquired an option from Pherin to license an additional CNS neuropsychiatry-focused product in Phase 2 development. In connection with the consummation of the license and option agreements, VistaGen issued to Pherin $2.25 million of unregistered common stock (1,630,435 unregistered shares).

PH94B was developed from proprietary compounds called pherines. Administered as a nasal spray, PH94B acts locally on peripheral nasal chemosensory receptors that trigger rapid activation of the limbic system areas of the brain associated with SAD. 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 intermittent and long-term treatment of individuals with SAD.

 SAD, also called social phobia, affects approximately 15 million American adults and is the third most common psychiatric condition after depression and substance use.2 SAD is characterized by a persistent and unreasonable fear of one or more social or performance situations, where the individual fears that he or she will act in a way or show symptoms that will be embarrassing or humiliating, leading to avoidance of the situations when possible and anxiety or distress when they occur.2 These fears have a significant impact on the person’s employment, social activities and overall quality of life. SAD is commonly treated chronically with antidepressants, which have a slow onset of effect (several weeks) and known side effects that may make them unattractive to individuals affected by SAD.

AV-101 is an oral, non-opioid, non-sedating NMDA receptor glycine B antagonist with potential to be a new at-home treatment for major depressive disorder and multiple CNS indications with high unmet need. AV-101 is currently in Phase 2 clinical development in the United States. ELEVATE is VistaGen’s ongoing Phase 2 clinical trial designed to evaluate the efficacy and safety of adjunctive use of oral AV-101 for MDD in individuals with an inadequate response to standard antidepressant therapy with either an FDA-approved SSRI or SNRI. The FDA has granted Fast Track designation to AV-101 for development as a potential adjunctive treatment of MDD.

VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing new generation medicines for depression, SAD and other CNS diseases and disorders with high unmet need. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Pherin Pharmaceuticals, Inc. is a privately held clinical-stage drug development company that discovered and developed proprietary molecules, “pherines,” for the acute and intermittent treatment of neuropsychiatric and neuroendocrine conditions. For more information please visit www.pherin.com.