VistaGen Therapeutics (NASDAQ: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (“CNS”) disorders, announced that the first cohort of healthy volunteers has been dosed in its U.S. phase 1 clinical trial of PH10. The trial includes a newly optimized formulation and is designed to confirm favorable safety profile from three previous clinical trials; the trial will also facilitate phase 2B development of PH10 as a standalone treatment for major depressive disorder (“MDD”). PH10 is an investigational pherine nasal spray. According to the announcement, the trial should be complete by the end of the first quarter of 2023, with top line results available before the end of the first half of 2023. “The initiation of this U.S. phase 1 study of Vistagen’s novel pherine nasal spray, PH10, represents a major milestone for our team as well as for the millions of individuals left struggling with major depressive disorder,” said VistaGen CEO Shawn Singh in the press release. “We expect this phase 1 trial to augment our record of favorable safety and tolerability data for PH10 across all prior clinical studies. Upon completion of the study and subsequent data readout, we will seek feedback from the FDA regarding potential phase 2B development of PH10 as a standalone treatment for major depressive disorder, building on past success in the phase 2A clinical program.”
To view the full press release, visit https://ibn.fm/r8yEg
About VistaGen Therapeutics Inc.
VistaGen is a late clinical-stage CNS-focused biopharmaceutical aiming 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 designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain. 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.
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