Vistagen, a biopharmaceutical company based in South San Francisco, has announced the results of its PALISADE-3 Phase 3 study, which evaluated the effectiveness of intranasal fasedienol for treating acute symptoms of social anxiety disorder. The study did not achieve its primary endpoint, as the data indicated no statistically significant improvement in the primary measure of effectiveness.
The trial assessed changes in participants’ scores on the Subjective Units of Distress Scale (SUDS), a tool used to quantify distress levels. The results showed a least squares (LS) mean change from baseline of 13.6 +/-1.54 standard error (SE) for fasedienol, compared to 14.0 +/-1.51 SE for placebo. This resulted in an LS mean difference of 0.4 (p = not significant), indicating no meaningful treatment effect.
Secondary Endpoints and Safety Profile
In addition to the primary endpoint, the study also evaluated several secondary endpoints, which similarly showed no significant differences between the fasedienol and placebo groups. Despite the lack of efficacy in these measures, Vistagen reported that the safety profile of fasedienol remained favorable and consistent with findings from previous clinical trials.
The PALISADE-3 study represents an important step in Vistagen’s efforts to develop innovative treatments for mental health disorders. While the results are disappointing, the company continues to explore other applications for its intranasal product candidates, known as pherines, which leverage nose-to-brain neurocircuitry for therapeutic effects.
Vistagen’s ongoing commitment to neuroscience and mental health solutions remains firm, as it seeks to address the unmet needs of individuals suffering from social anxiety disorder and other related conditions.
