Vistagen (NASDAQ:VTGN) announced disappointing results from its PALISADE-3 Phase 3 clinical trial of intranasal fasedienol, a treatment for social anxiety disorder.
The study failed to meet its primary endpoint, which was based on the change from baseline in the Subjective Units of Distress Scale (SUDS).
The treatment group showed a mean change of 13.6, while the placebo group showed a mean change of 14, with a least squares (LS) mean difference of just 0.4, which was not statistically significant (p=not significant).
No significant treatment difference was observed for secondary endpoints either.
Despite the negative outcome, Vistagen noted that the safety profile of fasedienol remained favorable, consistent with previous trials.
The company expressed disappointment in the results, which were unexpected given the positive outcomes observed in earlier studies, including the PALISADE-2 Phase 3 trial.
In light of the trial failure, the company is implementing cash preservation measures and will focus on operational efficiency to extend its financial runway into 2027 while preserving strategic options for its pipeline.
Vistagen will continue to evaluate the impact of these results on its ongoing clinical studies and intends to consult with the FDA regarding the future of fasedienol as a potential treatment for social anxiety disorder.