Phase 3 trial of nasal spray for treatment of anxiety disorders underway

SOUTH SAN FRANCISCO, Calif. and SHANGHAI: VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen) and AffaMed Therapeutics (AffaMed) today announced they have completed regulatory preparations to initiate PALISADE Global, a Phase 3 clinical trial to evaluate the efficacy, safety, and tolerability of VistaGen's PH94B (referred to by AffaMed as AM005) for the acute treatment of anxiety in adults with social anxiety disorder (SAD), in the U.S. and China. The primary purpose of PALISADE Global, the design of which is based on VistaGen's ongoing PALISADE-1 and PALISADE-2 Phase 3 clinical studies of PH94B in the U.S., is to support potential commercialization of PH94B in China and other markets outside of the U.S.

VistaGen's recent submission of the PALISADE Global study protocol to the U.S. Food and Drug Administration (FDA) under its existing PH94B Investigational New Drug (IND) application in SAD and AffaMed's recent receipt of regulatory clearance of its Clinical Trial Application (CTA) from the National Medical Products Administration (NMPA) in China have cleared the way for initiation of PALISADE Global in the U.S. and China during the second half of 2022. The companies also anticipate initiating this Phase 3 study in Canada, Mexico, and South Korea. PH94B is an odorless, fast-acting neuroactive pherine nasal spray with a unique potential mechanism of action (MOA) for the acute treatment of anxiety in adults with SAD. PH94B works differently than all therapies currently approved for the treatment of SAD by either the FDA or the NMPA.

"We are very pleased with the substantial progress that our teams have made toward initiating PALISADE Global in two of the world's largest pharmaceutical markets," said Shawn Singh, Chief Executive Officer of VistaGen. "AffaMed's clearance from the NMPA affirms our belief that AffaMed is the right partner for PH94B in China, and we remain confident in our collaboration as we advance this important late-stage clinical program for PH94B for the acute treatment of anxiety in adults with SAD. VistaGen remains committed to transforming the treatment of anxiety disorders for the millions of individuals worldwide who need better, safer, and faster-acting therapeutics in their journey toward mental health wellness."

"NMPA's clearance to begin the PALISADE Global Phase 3 trial is a tremendous milestone in advancing our product portfolio targeting neurological and psychiatric indications. I'm very proud of the dedication of our teams to bring forward a new treatment option for the rapidly growing number of individuals in China, South Korea, and Southeast Asia living with SAD," said Dr. Dayao Zhao, Chief Executive Officer of AffaMed. "We appreciate VistaGen's essential work in the U.S. under its PH94B IND application with the FDA. We thank the NMPA for recognizing the importance of this Phase 3 study and rapidly expediting the approval of our CTA. We look forward to dosing participants later this year."

In June 2020, VistaGen Therapeutics entered into a strategic licensing and collaboration agreement with AffaMed Therapeutics for the clinical development and commercialization of PH94B in China, South Korea, and Southeast Asia.

To date, health authorities in the U.S. and China have not approved any medications for acute (as-needed) treatment of anxiety in adults with SAD. SAD is commonly treated in the U.S. with certain antidepressants approved by the FDA, which have a slow onset (several weeks) and limited therapeutic benefits. Benzodiazepines, which are not FDA-approved for the treatment of SAD, are prescribed for off-label use. Both antidepressants and benzodiazepines have known side effects and safety concerns that may make them unattractive to many individuals affected by SAD.