- A psychometric analysis concluded that Subjective Units of Distress Scale (SUDS) is a psychometrically valid, sensitive, and reliable tool for evaluation of social anxiety.
- SUDS will be used as the primary outcome in future Phase 3 social anxiety disorder (SAD) clinical trials.
ADELAIDE, Australia and CAMBRIDGE, Mass., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (NASDAQ:BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced the presentation of data on the psychometric validity and reliability of SUDS as an outcome measure in assessing anxiety in SAD clinical trials at the 2023 American College of Neuropsychopharmacology Annual Meeting taking place December 3 – 6 in Tampa, Florida.
"We are excited to share the psychometric analysis we conducted of SUDS utilization in the Phase 2 PREVAIL trial of BNC210 in SAD, demonstrating it is a valid, reliable, and sensitive tool to assess anxiety," commented Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. "This presentation follows up the successful End-of-Phase 2 meeting we recently had with the U.S. Food and Drug Administration (FDA) where we agreed on the plan for our registrational study of BNC210 in SAD, including the measurement of SUDS during a public speaking challenge as the primary efficacy endpoint."
Key highlights from the poster presentation:
- BNC210 225 mg and 675 mg demonstrated reduced anxiety in patients with moderate to severe SAD in a public speaking challenge compared to placebo.
- BNC210 was well tolerated at both doses.
- Properties of the SUDS were evaluated to assess the SUDS's fit for measuring the reduction in self-reported anxiety severity provoked by a public speaking challenge in patients with SAD:
- Sensitivity: ...