Vistagen Says PALISADE-3 Phase 3 Study Of Intranasal Fasedienol For Acute Treatment Of Social Anxiety Disorder Did Not Demonstrate Statistically Significant Improvement On Primary Endpoint Of Change On SUDS

Study did not demonstrate statistically significant improvement on primary endpoint of reduction in anxiety as measured by SUDS scores compared to placebo

Favorable safety and tolerability data were consistent with previous studies

Company's cash preservation measures expected to provide runway into 2027

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 PALISADE-3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not demonstrate a statistically significant improvement on the primary endpoint of change on the Subjective Units of Distress Scale (SUDS). The trial did not achieve its primary endpoint, as measured by the least squares (LS) mean change from baseline on the Subjective Units of Distress Scale (SUDS) score for fasedienol (13.6 +/-1.54 standard error, SE) compared with placebo (14.0 +/-1.51 SE), a LS mean difference of 0.4 (p = not significant). There was no treatment difference between fasedienol and placebo for the secondary endpoints. The favorable safety data of fasedienol were consistent with previous clinical trials.