VistaGen Therapeutics Acquires Worldwide Rights to Develop & Commercialize First-in-Class Intranasally Administered Drug

VistaGen Therapeutics Inc. recently announced it has exercised its option to acquire from Pherin Pharmaceuticals, Inc. the exclusive license for worldwide rights to develop and commercialize PH10, a first-in-class, intranasally administered neuroactive steroid (a pherine), with rapid-onset antidepressant effects for treatment of major depressive disorder (MDD) demonstrated in a Phase 2a study. The company secured the option for PH10 concurrently with its previously announced license agreement with Pherin for worldwide rights to develop and commercialize PH94B, also a first-in-class neuroactive pherine, which VistaGen is preparing for pivotal Phase 3 development as a nasal spray for acute on-demand treatment of social anxiety disorder (SAD).

PH10 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.

Michael Liebowitz, MD, a member of VistaGen’s CNS Clinical and Regulatory Advisory Board, has acted as an advisor to Pherin in connection with its clinical trials of PH10 and PH94B and previously presented results for PH10’s 8-week, double-blind, single-center, 30-patient, Phase 2a study for MDD. Results in the Phase 2a study demonstrated that self-administered doses of PH10 as a nasal spray resulted in significant decreases in depression as measured by the Hamilton Rating Scale for Depression, a widely used clinician-administered depression assessment scale. In this study, PH10 was very well tolerated with minimal side effects.

“After extensive due diligence and guidance from Dr. Liebowitz, we exercised our option to acquire exclusive rights to develop and commercialize PH10 for depression and other CNS diseases,” said Shawn Singh, Chief Executive Officer of VistaGen. “Depression is a complicated disease, without a one-size-fits-all solution. Development of promising treatment alternatives with fundamentally different mechanisms of action from current antidepressants is a core competency of our team.  We are excited to build upon the notable and steadfast efforts of Dr. Louis Monti, Dr. Liebowitz and Pherin’s entire team in developing PH10 to date. PH10 marks yet another valuable asset in our growing pipeline, with compelling data and complementary to our core focus on developing innovative rapid-onset treatments for MDD beyond ketamine with convenient administration and without debilitating or psychological side effects and safety concerns. We believe that having yet another potentially safe, fast-acting, new generation mechanism of action treatment in play, in addition to AV-101 with its NMDAR GlyB and AMPAR targets, adds strength to strength, allowing us to provide patients with an even broader range of potential solutions to treat MDD, and expands our potential opportunities to monetize our assets to the benefit of our stockholders.”

“Depression is a pervasive mental illness and currently available treatments fall short for many individuals with the disease. 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,” stated Dr. Liebowitz.

Pherines inhibit nerve circuits mediating behavioral and physiological effects of anxiety. This mechanism of action, rapid onset of efficacy and excellent safety and tolerability profile have been shown in multiple previous clinical trials, including a pilot Phase 3 feasibility study evaluating the safety and efficacy of PH94B for SAD and Phase 2 feasibility study evaluating the safety and efficacy of PH10 for MDD.

In connection with the consummation of the license and option agreements, VistaGen issued to Pherin $2 million of its unregistered common stock (925,926 unregistered shares).

 VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing new generation medicines for multiple 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.