Vistagen, a biopharmaceutical company based in South San Francisco, has announced the results of its PALISADE-3 Phase 3 study concerning the use of intranasal fasedienol for the acute treatment of social anxiety disorder. The trial, which aimed to evaluate the efficacy of fasedienol, did not achieve the primary endpoint of demonstrating a statistically significant improvement in participants’ distress levels.
The primary endpoint of the study was measured using the Subjective Units of Distress Scale (SUDS). Results indicated a change in the SUDS score for fasedienol of 13.6 +/- 1.54 standard error (SE) compared to a score of 14.0 +/- 1.51 SE for the placebo group. This resulted in a least squares (LS) mean difference of 0.4, which was deemed not statistically significant (p = not significant). Furthermore, no treatment differences were observed between fasedienol and placebo for secondary endpoints.
Safety Profile Remains Favorable
Despite the lack of efficacy in achieving the primary endpoint, Vistagen reported that the safety profile of fasedienol was consistent with findings from previous clinical trials. The favorable safety data suggests that the treatment may still hold promise for future studies, though the current trial outcomes have raised questions regarding its immediate applicability for those suffering from social anxiety disorder.
Vistagen has been at the forefront of developing a new class of intranasal product candidates known as pherines, which utilize innovative neuroscience techniques targeting the nose-to-brain neurocircuitry. While the PALISADE-3 results may present a setback, the company remains focused on advancing its research and exploring further treatment options for social anxiety.
As Vistagen navigates the implications of these findings, the biopharmaceutical industry will be observing closely, especially regarding the potential for future trials and developments in the treatment of social anxiety disorder.
