VistaGen Says Data From Late-Stage Anxiety Study 'Not Consistent' With Prior Positive Phase 2 Study

VistaGen Therapeutics Inc VTGN has announced topline results from its PALISADE-1 Phase 3 trial of PH94B for the acute treatment of social anxiety disorder.
PH94B did not achieve its primary endpoint, as measured by change from baseline using the Subjective Units of Distress Scale (SUDS) compared to placebo.
SUDS rating scale is used to measure the intensity of distress or nervousness in people with social anxiety.
Social anxiety disorder affects an estimated 25 million Americans.
Although the trial did not meet its primary endpoint, the tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported trials.
No severe or serious adverse events were reported.
The company will continue to develop PH94B's potential as a new treatment option for multiple anxiety disorders, including acute treatment for social anxiety disorder in the ongoing PALISADE-2 Phase 3 trial and Phase 2 trial in adjustment disorder with anxiety.
PALISADE-2 is on track for a topline readout in late 2022.
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