ADELAIDE, Australia and CAMBRIDGE, Mass., May 30, 2023 (GLOBE NEWSWIRE) — Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators for serious central nervous system (CNS) disorders with a high unmet medical need, today announced it will present data on BNC210 for the treatment of Social Anxiety Disorder (SAD) at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting taking place Tuesday, May 30, 2023, through Friday, June 2, 2023, in Miami Beach, Florida.
The presentation will include previously announced data from Phase 2 PREVAIL study of BNC210 for the acute treatment of SAD, which support the late-stage development of the drug for this indication. In addition, the presentation will highlight details on the trial’s public speaking task, the statistical analysis methodologies utilized for prespecified and post-hoc data analyses, previously undisclosed baseline characteristics, and gender subgroup analyses supporting similar treatment effects in males and females. Collectively, these analyses further support BNC210’s potential as a non-sedating anxiolytic for the acute treatment of SAD and may inform future registrational trial designs, including the selection of endpoints and population.
“PREVAIL’s results demonstrate BNC210’s differentiated profile and potential to address a pressing unmet need, as there are currently no rapid-acting, non-sedating, non-habit-forming therapies approved for the acute treatment of anxiety episodes in SAD,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “We look forward to discussing these results with the global psychopharmacology community at ASCP, especially as we prepare for an FDA End of Phase 2 meeting to discuss a registrational program in SAD. With BNC210 supported by a robust clinical dataset and Fast Track Designation, we believe we are well positioned as we work to advance this potentially first and best-in-class therapy through the regulatory process and towards approval.”
Details on the upcoming ASCP poster are shown below.
Title: A Phase 2, Double-Blind, Placebo-Controlled Study for BNC210, an alpha7 Nicotinic Receptor Negative Allosteric Modulator (NAM) for the Acute Treatment of Social Anxiety Disorder (PREVAIL): Top-Line Efficacy and Safety Results.
Session Type: Poster Session I
Abstract Number: W8
Date and Time: Wednesday, May 31, 2023, 11:15 AM – 1:00 PM (EDT)
The PREVAIL trial enrolled 151 adult patients at 15 sites with diagnosed SAD and who rated ≥ 70 on the Liebowitz Social Anxiety Scale. Study participants were randomized 1:1:1 to receive a single dose of either a placebo or 225 mg or 675 mg BNC210. All participants completed the study. After dosing, there was a 55-minute rest period followed by reading the challenge instructions, a 2-minute anticipation-preparation period, a 5-minute speaking challenge, and a 30-minute post-challenge period. The primary outcome measure was a self-assessment during the speaking challenge using the Subjective Units of Distress Scale (SUDS), a standard visual analog scale from 0-100 that measures the intensity of anxiety and/or distress. SUDS is widely considered to be the most qualified outcome measure in social anxiety trials that utilize the public speaking task. Secondary outcome measures included self-assessment with SUDS during the preparation-anticipation phase and self-assessment with the State-Trait Anxiety Inventory (STAI, State subscale), a self-reported questionnaire with 20 anxiety-related questions marked on a 4-point scale and the Self-Statements During Public Speaking scale (SSPS, negative self-statements), a 5-item questionnaire capturing negative cognitions during a public speaking situation.
About Social Anxiety Disorder
SAD is a significant and persistent fear of social and performance-related situations. One of the most common mental disorders in the United States, an estimated 31 million Americans will suffer from SAD at some point in their lives. SAD can interfere with a person’s ability to work, make it difficult to maintain friendships, family relationships, and romantic partnerships, cause a person to avoid lifestyle activities like dining out and traveling, and make normal parts of everyday life such as grocery shopping, calling a handyperson, or picking up coffee challenging.
Formulated as a solid oral tablet, BNC210 is a negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the acute treatment of SAD and chronic treatment of Post-Traumatic Stress Disorder (PTSD). BNC210 has been given FDA Fast Track designation for acute treatment of SAD and other anxiety-related disorders, and for treatment of PTSD and other trauma and stressor-related disorders.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Ms. Suzanne Irwin
+61 8 8150 7400
Mr. Connor Bernstein
Vice President, Strategy
and Corporate Development
+1 (650) 524-5143
About Bionomics Limited
Bionomics (ASX:BNO, NASDAQ:BNOX) is a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious 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 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 the Company’s Annual Report on Form 20-F filed with the SEC on October 14, 2022, 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.
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