Vistagen has announced that the Phase 3 PALISADE-3 study of intranasal fasedienol for the treatment of social anxiety disorder failed to meet its primary endpoint, with fasedienol failing to demonstrate a statistically significant reduction of distress in a public speaking challenge compared to placebo. The company also said that the fasedienol and placebo were equivalent on the secondary endpoints.
The initiation of the PALISADE-3 trial was announced in April 2024 and followed by the initiation of the PALISADE-4 trial in September 2024. Both of those trials had protocols similar to the Phase 3 PALISADE-2 trial, which was paused in 2022 after the PALISADE-1 trial failed to meet its primary endpoint. The following year, Vistagen said that PALISADE-2 had met its primary endpoint.
Vistagen President and CEO Shawn Singh commented, “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. 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.”
Read the Vistagen press release
