VistaGen Therapeutics, a clinical-stage biopharmaceutical company, and EverInsight Therapeutics, a biopharmaceutical company, have entered into a strategic licensing and collaboration agreement for the clinical development and commercialization of PH94B, VistaGen's novel, rapid-onset neurosteroid drug candidate for multiple anxiety-related disorders, in Greater China, South Korea and Southeast Asia.
In December 2019, VistaGen received Fast Track designation from the US Food and Drug Administration (FDA) for development of PH94B for treatment of social anxiety disorder (SAD), the FDA's first Fast Track designation for a SAD drug candidate. The goal of the collaboration is to advance and support phase 3 developments and commercialization of PH94B as a potentially groundbreaking anti-anxiety medicine for patients in Greater China and other important Asian markets.
Under the terms of the agreement, EverInsight will be responsible for clinical development, regulatory submissions and commercialization of PH94B neuroactive nasal spray for acute treatment of SAD, and potentially other anxiety-related indications, in markets in Greater China (Mainland China, Hong Kong, Macau and Taiwan), South Korea and Southeast Asia (Indonesia, Malaysia, Philippines, Thailand and Vietnam) (the Territory). EverInsight will make a non-dilutive upfront payment of US$ 5 million to VistaGen, and VistaGen is eligible to receive additional development and commercial milestone payments of up to US$ 172 million. VistaGen will receive tiered royalties on sales of PH94B in the Territory, if phase 3 development efforts are successful. VistaGen retains exclusive rights to develop and commercialize PH94B in all markets outside the Territory.
“We are pleased to collaborate with EverInsight, a company that shares our vision and excitement for bringing PH94B, a potentially transformative treatment for multiple anxiety disorders, to millions of individuals with unmet needs around the world. EverInsight is an ideal partner to support phase 3 clinical development and commercial launch of PH94B in Greater China and other Asian markets, as we continue to focus on those activities in the US,” stated Shawn Singh, chief executive officer of VistaGen. “Anxiety, including social anxiety disorder, is a common and potentially debilitating illness that can have significant emotional, functional and economic effects on those who suffer, as well as their families, friends and colleagues. With the recent onset of mental health stressors associated with the COVID-19 pandemic and social justice unrest, the rising prevalence of anxiety, depression, and suicide is alarming. PH94B has a fundamentally different mechanism of action than all current treatments for social anxiety disorder and numerous other anxiety disorders, arguably the first new rapid-onset mechanism of action for treatment of anxiety in several decades. Our strategic collaboration today with EverInsight positions PH94B one step closer to becoming a potentially paradigm-shifting new treatment alternative for individuals worldwide.”
“We partner with innovative companies that develop novel medicines with large commercial potential in Greater China and other Asian markets. PH94B is an extremely valuable asset that the world desperately needs today to provide potential relief from the debilitating impact of anxiety on daily life,” said Sean Cao, managing director of CBC Group, which is currently funding EverInsight. "We are delighted to partner with VistaGen's team and are highly confident in our plan to advance PH94B through the necessary clinical development and approval process focused on successful commercialization in our core markets.”
PH94B is a first-in-class, odorless, rapid-onset (within approximately 15 minutes) synthetic neurosteroid nasal spray with therapeutic potential across a broad range of anxiety-related disorders. Easily self-administered in microgram doses, PH94B does not require systemic uptake and distribution to produce its rapid-onset anti-anxiety effects.
VistaGen is initially developing PH94B as a potential fast-acting, non-sedating, non-addictive new generation acute treatment of social anxiety disorder (SAD), as well as for adjustment disorder with anxiety related to the COVID-19 pandemic. With its rapid-onset pharmacology, lack of systemic exposure and excellent safety profile, PH94B also has potential as a novel treatment for postpartum anxiety, post-traumatic stress disorder, preoperative anxiety, panic disorder and other anxiety-related disorders.