VistaGen Therapeutics (NASDAQ: VTGN), a late clinical-stage, central nervous system (“CNS”) focused biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders, announced that the last patient had completed the study protocol in its PALISADE-1 phase 3 clinical study. The study evaluated the potential for VTGN’s proprietary PH94B as a rapid-onset, acute-treatment option for adults dealing with social anxiety disorder (“SAD”). According to the announcement, the company anticipates top-line results in the coming weeks. VTGN’s PH94B is a first-in-class, odorless, tasteless, rapid-onset investigational pherine nasal spray that features a novel mechanism of action, which regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system. According to the announcement, the PALISADE-1 phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel design, clinical study conducted in the United States. The study evaluated adults diagnosed with SAD and measured the efficacy, safety and tolerability of PH94B. “We would like to thank the many individuals currently living with social anxiety disorder who participated in PALISADE-1, as well as Dr. Michael Liebowitz, the principal investigator in the study and a leading expert in SAD, the clinical site investigators and their teams, and our CRO,” said VistaGen CEO Shawn Singh in the press release. “Together with our internal team, all are an integral part of our PALISADE phase 3 program for PH94B. Social anxiety disorder affects an estimated 25 million individuals in the United States, and this milestone further reflects our Company’s continuing commitment to develop novel treatment options with potential to go beyond the current standard of care for widespread mental health disorders.”
To view the full press release, visit https://ibn.fm/5Tt0w
About VistaGen Therapeutics Inc.
VistaGen is a late clinical-stage, CNS-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 clinical-stage candidates are targeting multiple forms of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are odorless, tasteless neuroactive steroids that bind to distinct receptors on chemosensory neurons in the nasal passages and can impact the limbic amygdala with rapid onset and without systemic uptake or direct activity on CNS neurons in the brain. VistaGen’s lead candidate, PH94B, is a nasally administered spray currently in multiple phase 3 trials in the United States, with top-line results anticipated this year. 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. VistaGen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression. For more information about the company, please visit www.VistaGen.com.
NOTE TO INVESTORS: The latest news and updates relating to VTGN are available in the company’s newsroom at https://ibn.fm/VTGN
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