Bionomics presents detailed data on validity, reliability of SUDS

Bionomics announced the presentation of data on the psychometric validity and reliability of Subjective Units of Distress Scale, 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 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: No floor or ceiling effects were observed in the use of the SUDS in the PREVAIL study indicating it is highly sensitive to change over the entirety of its range. Reliability: The reliability of the SUDS at 20- and 30-minutes post-challenge was very high for both the placebo and the full population. Validity: Baseline SUDS scores demonstrated good convergent validity when compared with State-Trait Anxiety Inventory scores.