Vistagen Therapeutics (NASDAQ:VTGN) announced completion of an interim analysis of PALISADE-2, its second Phase 3 clinical trial assessing drug candidate, PH94B, as an acute treatment of anxiety in adults with social anxiety disorder, which concluded that PALISADE-2 should continue as planned.
Independent 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 social anxiety disorder.
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.
“We believe that the recommendation resulting from the interim analysis to resume PALISADE-2 is the best course of action,” Shawn Singh, CEO of Vistagen, said in a statement.
“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,” he added.