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Vistagen to Proceed with PALISADE-2 Phase 3 Clinical Trial of PH94B in Social Anxiety Disorder following Interim Analysis
Independent biostatisticians recommend continuing PALISADE-2 without any changes after conducting interim analysis of 140 completed subjects Topline data for
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nIndependent biostatisticians recommend continuing PALISADE-2 without any changes after conducting interim analysis of 140 completed subjects\n\nTopline data for PALISADE-2 trial expected in the first half of 2023\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen Therapeutics, Inc. (Nasdaq: VTGN) (Vistagen, the Company), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today announced the completion of an interim analysis of PALISADE-2, the Company’s second Phase 3 clinical trial assessing drug candidate PH94B as an acute treatment of anxiety in adults with Social Anxiety Disorder (SAD), which concluded that PALISADE-2 should continue as planned.\n\nIndependent biostatisticians reviewed unblinded data from the 140 subjects who completed PALISADE-2 before the Company paused enrollment in the study in July 2022, following announcement of topline results from PALISADE-1, its first Phase 3 clinical trial of PH94B in SAD. Although the Company does not itself have access to unblinded data from PALISADE-2, based on the outcome of the interim analysis and the recommendation of the independent biostatisticians, Vistagen will continue PALISADE-2 as planned to the full enrollment of 208 subjects, without any adjustment to the size of the study. Vistagen expects topline results from PALISADE-2 in the first half of 2023.\n\n“We are encouraged by the recommendation to continue PALISADE-2 to full enrollment as originally planned,” said Shawn Singh, Chief Executive Officer of Vistagen. “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...