Vistagen Therapeutics has announced that it will restart the Phase 3 PALISADE-2 trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder (SAD), which the company had paused after the PALISADE-1 trial failed to meet its primary endpoint. According to Vistagen, an independent interim analysis of unblinded data from 140 subjects from PALISADE-2 has been completed, and the company was advised to continue the study without changes. Topline results are expected to be available in the first half of 2023.
The company announced the initiation of the PALISADE-1 trial in May 2021 and the PALISADE-2 trial in September 2021. Both studies were designed with essentially the same format and were expected to enroll ~200 subjects and include a public speaking challenge.
Vistagen CEO Shawn Singh said, “We are encouraged by the recommendation to continue PALISADE-2 to full enrollment as originally planned. Following the results of PALISADE-1, we had independent biostatisticians conduct the interim analysis to gain insight on the best course of action for PALISADE-2, including possibly expanding the number of subjects in the study, significantly amending the study protocol or halting the study altogether. We believe that the recommendation resulting from the interim analysis to resume PALISADE-2 is the best course of action. While we further evaluate the results of PALISADE-1, building on both the continuation of PALISADE-2 and preliminary data from our open label safety study of PH94B, we are also preparing to meet with the FDA later this year to discuss our plans for further Phase 3 development of PH94B in social anxiety disorder.”
Read the Vistagen Therapeutics press release.
