Vistagen to continue phase 3 clinical trial of social anxiety treatment
Vistagen Therapeutics announced the completion of an interim analysis of PALISADE-2, the company’s second phase 3 clinical trial assessing PH94B in adults with social anxiety disorder, and concluded the trial should continue as planned.
According to a release from Vistagen, independent biostatisticians reviewed unblinded data from 140 subjects who completed PALISADE-2 before the company paused enrollment in July. The interruption occurred after Vistagen announced topline results from PALISADE-1, its first phase 3 clinical trial of PH94B in social anxiety disorder.
The release additionally stated that Vistagen does not have access to unblinded data from PALISADE-2. However, based on the outcome of the interim analysis and recommendation of the independent biostatisticians, PALISADE-2 will continue as planned with the full enrollment of 208 subjects, with no adjustment to the size of the study.
Topline results from the completed PALISADE-2 are expected by the first half of 2023.
“We are encouraged by the recommendation to continue PALISADE-2 to full enrollment as originally planned,” Vistagen CEO Shawn Singh said in the release. “We believe that the recommendation resulting from the interim analysis to resume PALISADE-2 is the best course of action.”
PH94B is a fast-acting, odorless pherine administered intranasally at microgram doses. It is currently in clinical trials to treat multiple anxiety disorders without the side effects and safety concerns associated with currently prescribed and off-label medications, Vistagen said in the release.
PH94B demonstrated tolerability in PALISADE-1 consistent with reported results from previous clinical trials. No severe or serious adverse events were reported for PH94B in PALISADE-1, PALISADE-2 or in other clinical trials, the company said.
Singh added that, while Vistagen will further evaluate the results of PALISADE-1, the company is also preparing to meet with the FDA later this year to discuss its plans for continued phase 3 development of PH94B.