Vistagen reports positive Phase 3 trial results of Fasedienol in SAD

Vistagen Therapeutics reported positive top-line results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol nasal spray in adults diagnosed with social anxiety disorder, or SAD. The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo. The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale. Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials. In June 2020, VistaGen entered into a strategic licensing and collaboration agreement with AffaMed Therapeutics for the clinical development and commercialization of PH94B in China, South Korea, and Southeast Asia.