VistaGen Therapeutics Inc. (NASDAQ: VTGN) has revealed topline findings from the third phase PALISADE-1 study of PH94B for the treatment of acute social anxiety disorder.
PH94B failed to meet the primary objective
When compared to placebo, PH94B failed to meet its primary endpoint, which was determined by improvement from baseline on the Subjective Units of Distress Scale (SUDS). PH94B’s tolerability profile in the PALISADE-1 study was favorable and comparable with initially disclosed findings from all previous clinical studies, despite the trial’s primary aim not being met. In PALISADE-1 or earlier clinical trials, no severe or life-threatening adverse events were associated with PH94B.
The company’s CEO, Shawn Singh, said, “The demand for new treatment options for anxiety disorders is large and growing. While the results of PALISADE-1 are not consistent with prior positive results from Phase 2 trials of PH94B in social anxiety disorder, we remain committed to transforming the treatment landscape for those living with anxiety, depression, and other central nervous system disorders.”
As part of the company’s commitment, its team will keep looking into the prospects of PH94B as a new potential treatment for a variety of anxiety disorders, including the acute treatment of social anxiety disorder in the continuing PALISADE-2 third Phase trial and the ongoing use of adjustment disorder with anxiety in the ongoing Phase 2 trial.
Singh added, “We would like to thank the patients and investigators for their participation in the trial, and we will continue to evaluate the detailed data from PALISADE-1 as we move forward with our ongoing trials.”
Study evaluated patient’s public speaking
Adults with a social anxiety disorder(SAD) participated in the multi-center, randomized, placebo-controlled, double-blind, parallel design, Phase 3 clinical investigation known as PALISADE-1. The trial’s objective was to assess the effectiveness, safety, and tolerability profile of acute PH94B delivery to reduce anxiety symptoms in adult SAD participants throughout a modeled public speaking assignment as assessed by patient-reported SUDS. The subjects were randomly assigned to be given a single dosage of PH94B or a placebo before the public speaking test.