Bionomics Presents Detailed Data on the Validity and Reliability of the Subjective Units of Distress Scale at the 2023 American College of Neuropsychopharmacology Annual Meeting

Rhea-AI Summary

Bionomics Limited (BNOX) announced the psychometric analysis of Subjective Units of Distress Scale (SUDS) as a valid, reliable, and sensitive tool for assessing anxiety in social anxiety disorder (SAD) clinical trials. The presentation, held at the 2023 American College of Neuropsychopharmacology Annual Meeting, highlighted the successful Phase 2 PREVAIL trial of BNC210 in SAD, where BNC210 demonstrated reduced anxiety and was well tolerated. The company also agreed on the plan for a registrational study of BNC210 in SAD, with SUDS as the primary efficacy endpoint. The upcoming Phase 3 trial is expected to begin in Q1’24.

• 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: 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 (STAI) scores.

SUDS will be used to assess the effect of BNC210 on reduction in anxiety during a public speaking challenge in the upcoming Phase 3 trial, which is anticipated to begin in Q1’24.

The poster presentation is available for viewing under the Publications webpage of the Company’s website.

FOR FURTHER INFORMATION PLEASE CONTACT:

General Rajeev Chandra Company Secretary CoSec@bionomics.com.au	Investor Relations Kevin Gardner kgardner@lifesciadvisors.com	Investor Relations Chris Calabrese ccalabrese@lifesciadvisors.com

About Bionomics Limited
Bionomics (NASDAQ: BNOX) is 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. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need. www.bionomics.com.au

Forward-Looking Statements
Bionomics cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timing of achieving any development or regulatory milestones, and the comparability and potential of such product candidates, including to achieve any benefit or profile or any product approval or be effective. The inclusion of forward-looking statements should not be regarded as a representation by Bionomics that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, the Company’s Annual Report on Form 20-F filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Bionomics undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Bionomics’ filings with the SEC which are available from the SEC’s website (www.sec.gov) and on Bionomics’ website (www.bionomics.com.au) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

FAQ

What did Bionomics Limited announce at the 2023 American College of Neuropsychopharmacology Annual Meeting?

Bionomics Limited announced the psychometric analysis of SUDS as a valid, reliable, and sensitive tool for assessing anxiety in SAD clinical trials.

What were the key highlights from the poster presentation?

BNC210 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.

What is the plan for the upcoming Phase 3 trial of BNC210 in SAD?

SUDS will be used to assess the effect of BNC210 on reduction in anxiety during a public speaking challenge in the upcoming Phase 3 trial, which is anticipated to begin in Q1’24.