VistaGen (NASDAQ: VTGN) is 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. The company today announced topline results from its PALISADE-1 phase 3 clinical trial of PH94B for the acute treatment of anxiety in adults with social anxiety disorder. According to the update, PH94B did not achieve its primary endpoint, as measured by change from baseline using the Subjective Units of Distress Scale (“SUDS”) compared to placebo. However, the tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported results from all other clinical trials. No severe or serious adverse events were reported for PH94B in prior clinical trials or in PALISADE-1.
“The demand for new treatment options for anxiety disorders is large and growing. While the results of PALISADE-1 are not consistent with prior positive results from phase 2 trials of PH94B in social anxiety disorder, we remain committed to transforming the treatment landscape for those living with anxiety, depression and other central nervous system disorders,” said Shawn Singh, chief executive officer of VistaGen. “As part of this commitment, our team will continue to pursue PH94B’s potential as a new treatment option for multiple anxiety disorders — including for both acute treatment for social anxiety disorder in our ongoing PALISADE-2 phase 3 trial and for continued use in our ongoing phase 2 trial in adjustment disorder with anxiety. We would like to thank the patients and investigators for their participation in the trial, and we will continue to evaluate the detailed data from PALISADE-1 as we move forward with our ongoing trials.”
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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. VistaGen’s pipeline includes three CNS drug candidates, PH94B, PH10 and AV-101, with the potential to go beyond the current standard of care for CNS indications with high unmet need. Each of the company’s drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date, and has therapeutic potential in multiple CNS markets. PH94B is a first-in-class investigational pherine nasal spray in phase 3 development for the acute treatment of anxiety in adults with social anxiety disorder and in phase 2 development for adjustment disorder with anxiety. VistaGen is also considering PH94B for clinical development in additional acute (on-demand) and continued use anxiety disorders, including procedural anxiety, panic disorder, postpartum anxiety and post-traumatic stress disorder. PH10 is an investigational pherine nasal spray in clinical development as a stand-alone treatment for major depressive disorder and potentially multiple other depression-related disorders. AV-101 is an investigational oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA), a potent and selective full antagonist of the glycine co-agonist site of the NMDAR, in clinical development with potential to become a new oral treatment alternative for certain CNS indications involving the NMDAR. For more information, visit the company’s website at www.VistaGen.com.
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