Bionomics' Social Anxiety Disorder Study Fails To Meet Primary Endpoint

  • Bionomics Limited BNOX announced results from its Phase PREVAIL study of BNC210 for the acute treatment of Social Anxiety Disorder (SAD). 
  • The trial enrolled 151 adult patients. The primary endpoint, measured by the change from baseline to the average of the Subjective Units of Distress Scale (SUDS) scores during a 5-minute Public Speaking Challenge, was not met in the BNC210-treated patients when compared to placebo.
  • SUDS is a tool for quantifying the intensity of anxiety, fear, or distress on a scale from 0 to 100, with 0 indicating no distress and 100 representing the highest level.
  • The findings indicate a consistent trend toward improvements across primary and secondary endpoints and a favorable safety and tolerability profile. 
  • The company is continuing its analysis of the PREVAIL dataset and is assessing the next steps for developing BNC210 in SAD.
  • The company is conducting a Phase 2b ATTUNE Study in PTSD with topline data expected mid-2023. 
  • The company said that its cash position would deliver these milestones and continue operations to at least mid-2024.
  • Price Action: BNOX shares closed at $6.80 on Friday.
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