VistaGen Therapeutics, Inc. (NASDAQ: VTGN) announced topline results from its PALISADE-1 Phase 3 clinical trial of PH94B for the treatment of anxiety in adults with social anxiety disorder. PH94B did not reach its primary endpoint. “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.”
PALISADE-1 was a multi-center, randomized, double-blind, placebo-controlled, parallel design, Phase 3 clinical study in adults diagnosed with social anxiety disorder (SAD). The study was designed to evaluate the efficacy, safety, and tolerability of the acute administration of PH94B to relieve symptoms of anxiety in adult patients with SAD during a simulated public speaking challenge, measured using the patient-reported SUDS. Prior to the public speaking challenge, the subjects were randomized to receive a single dose of PH94B or placebo.