Vistagen (NASDAQ:VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the last patient has completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Company's Phase 3 clinical trial evaluating fasedienol nasal spray for the acute treatment of social anxiety disorder. The open label extension (OLE) portion of the PALISADE-4 study remains ongoing.

"The completion of the randomized portion of PALISADE-4 is another important step for our fasedienol Phase 3 program in social anxiety disorder, and we expect to announce topline results this quarter," said Shawn Singh, President and Chief Executive Officer. "We extend our sincere thanks to the participants, clinical investigators, site staff, and contract research organization whose hard work, collaboration, and commitment brought this portion of the study to completion."

PALISADE-4 is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical study designed to evaluate the efficacy, safety, and tolerability of a single dose of fasedienol in reducing anxiety symptoms in adults with social anxiety disorder during a simulated anxiety-provoking public speaking challenge conducted in a clinical setting using the Subjective Units of Distress Scale (SUDS) as the primary endpoint. Participants in the randomized portion of PALISADE-4 who chose to continue with the OLE portion of the study can use fasedienol in their daily lives up to six times per day for up to twelve months.

As previously announced, Vistagen continues to analyze datasets from the randomized portions of the PALISADE-1, PALISADE-2, and PALISADE-3 Phase 3 studies for fasedienol for the acute treatment of social anxiety disorder, including with the assistance of collaborators and proprietary artificial intelligence and machine learning methodologies. Based on these analyses, Vistagen refined the statistical analysis plan (SAP) for PALISADE-4 to incorporate each participant's distress level immediately prior to dosing, as measured by the SUDS (pre-IP SUDS), into the primary efficacy analysis. While there is no guarantee the Company's refinements to the PALISADE-4 SAP will result in a positive outcome for the study, Vistagen believes the refined SAP reflects established statistical principles supporting the use of baseline covariates in randomized clinical trials consistent with U.S. Food and Drug Administration (FDA) guidance regarding adjustments for covariates (Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products, May 2023). The FDA has informed the Company that it has no comments on the refinements to the PALISADE-4 SAP. No changes were made to the PALISADE-4 clinical study protocol as a result of the ongoing dataset analyses or refinement of the PALISADE-4 SAP.

The FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of social anxiety disorder. Vistagen believes that PALISADE-4, if successful, together with the positive results from its PALISADE-2 Phase 3 trial and further evidence Vistagen plans to generate to support the clinical meaningfulness of the duration and magnitude of effect of fasedienol, could provide substantial evidence of fasedienol's effectiveness in support of a potential New Drug Application (NDA) submission to the FDA for the acute treatment of social anxiety disorder.