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, has announced key updates regarding its phase 1 clinical trial of itruvone (“PH10”). The company reported that the last participant in the trial has completed the study protocol. PH10 is VistaGen’s investigational pherine nasal spray for the treatment of major depressive disorder (“MDD”). According to the announcement, the study was designed to confirm the favorable safety profile of itruvone, which had been established in three previous clinical studies conducted in Mexico. The company expects to see top line results from the study in Q2 2023. “With the treatment protocol for our final enrolled participant complete, we look forward to reviewing the data and advancing phase 2B development plans for itruvone as an innovative treatment for major depressive disorder,” said VistaGen Therapeutics CEO Shawn Singh in the press release. “Major depressive disorder continues to disrupt the lives of millions of individuals, and there is clear need for safer, more effective treatments, especially treatments with potential for rapid-onset and sustained benefits without causing sexual side effects or weight gain. We anticipate this U.S. phase 1 trial will build on itruvone’s exceptional safety and tolerability profile as demonstrated in all prior clinical studies to date.”
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About VistaGen Therapeutics Inc.
Vistagen is a late clinical-stage biopharmaceutical company 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 for treatment of anxiety and depression. Several of Vistagen’s product candidates belong to a new class of drugs known as pherines, which are designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact key 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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