VistaGen Therapeutics, Inc. (VTGN) announced topline data and post-hoc analysis results from the Phase 3 clinical trial Palisade-4 of its candidate drug Fasedienol for the acute treatment of social anxiety disorder.
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The trial was assessed using the public speaking challenge model. Data shows that there was no statistically significant difference between the Fasedienol treatment group and the placebo group in both the primary endpoint and the key secondary endpoint. However, exploratory post-hoc analyses conducted by the company indicated that signals of clinically meaningful improvement were observed in a pre-specified subgroup population. The data released provides important guidance for subsequent clinical development strategies. The company stated it will continue to analyze the complete data set in depth to further clarify the potential therapeutic value of Fasedienol.
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