VistaGen (NASDAQ: VTGN) and AffaMed Therapeutics have announced completion of 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, 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. “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 VistaGen CEO Shawn Singh. “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.”
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About VistaGen Therapeutics Inc.
VistaGen is a late clinical-stage, neuro-focused biopharmaceutical company striving to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The company is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those that are currently available. VistaGen’s lead candidates are targeting multiple forms of anxiety and depression. They belong to a new class of drugs known as pherines, which are odorless, neuroactive steroids that bind to distinct receptors on chemosensory neurons in the nasal passages and can impact the limbic amygdala without systemic uptake or direct activity on CNS neurons in the brain. VistaGen’s lead asset, PH94B, is a nasally administered spray currently in multiple phase 3 trials in the U.S., with results anticipated in 2022. Should ongoing phase 3 studies be successful, PH94B has the potential to be the first FDA-approved, fast-acting, acute treatment of anxiety for adults with social anxiety disorder. With an experienced leadership team and a steady flow of near- and long-term potential milestones, VistaGen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression. For more information, visit the company’s website at www.VistaGen.com.
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