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Wed. 22 Jun 2022, 8:34am ET Benzinga News, FDA

VistaGen Therapeutics, Inc. (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, today announced that the last patient has completed the study protocol in its PALISADE-1 Phase 3 clinical trial of PH94B for the acute treatment of anxiety in adults with social anxiety disorder (SAD).

VistaGen's PALISADE-1 Phase 3 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled, parallel design, clinical study in adults diagnosed with SAD. The study is designed to evaluate the efficacy, safety, and tolerability of the acute administration of PH94B to relieve symptoms of anxiety in adult patients living with SAD during a simulated public speaking challenge conducted in a clinical setting, measured using the Subjective Units of Distress Scale (SUDS). Topline results from VistaGen's PALISADE-1 Phase 3 clinical study are anticipated in mid-2022, consistent with the Company's prior guidance.

"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. 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," said Shawn Singh, Chief Executive Officer of VistaGen.

VistaGen is also evaluating PH94B for SAD in a second Phase 3 clinical trial, PALISADE-2, a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed as a replicate of PALISADE-1 to evaluate the efficacy, safety, and tolerability of PH94B for the acute treatment of anxiety in adults with SAD. Topline results from PALISADE-2 are anticipated in late-2022.