Vistagen SAD study did not achieve primary endpoint

Vistagen (VTGN) 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. The trial did not achieve its primary endpoint, as measured by the least squares mean change from baseline on the Subjective Units of Distress Scale score for fasedienol compared with placebo, a LS mean difference of 0.4. 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. “We are disappointed by the unexpected results of this public speaking challenge trial, which are inconsistent with positive outcomes observed in Phase 2 and our PALISADE-2 Phase 3 study,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “We are thoroughly reviewing the results of the study, evaluating the potential impact of the results on our ongoing studies and plan to seek feedback from the FDA. In parallel, we are implementing company-wide cash preservation measures in an effort to enhance operational efficiency, provide cash runway into 2027, and maintain strategic optionality across our pherine pipeline. I’d like to thank the patients, coordinators, and investigators, as well as the development team at Vistagen, for their time and efforts in conducting this trial.”