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.
  • Price Action: VTGN shares are down 81% at $0.20 during the premarket session on the last check Friday.
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