Bionomics Reports Best Results in Phase 2 PREVAIL Study

  • BNC210 for the treatment of social anxiety disorder (SAD) missed its primary endpoint
  • Subjects with confirmed SAD who received BNC210 showed trends toward improvements across endpoints compared to placebo
  • BNC210 demonstrated a favorable safety and tolerability profile consistent with previous experience
  • Company is continuing data analysis and evaluation of next steps with Cash Runway through mid-2024

ADELAIDE, Australia, Dec. 18, 2022 (GLOBE NEWSWIRE) — Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators designed to transform the lives of patients with severe central nervous system (CNS) disorders with high unmet medical needs, today announced results from the Phase 2, randomized, double-blind, placebo-controlled, multicenter, dose-ranging PREVAIL study to evaluate the safety, tolerability and efficacy of BNC210 for the acute treatment of social anxiety disorder (SAD). BNC210 has a novel mechanism of action involving negative allosteric modulation of the α7 nicotinic acetylcholine receptor. While the primary endpoint measured by change from baseline to mean in Subjective Units of Distress Scale (SUDS) scores during a 5-minute public speaking challenge was not met in patients treated with BNC210 versus placebo, the results do not indicate a continued trend toward improvements across the primary and secondary endpoints, and a favorable safety and tolerability profile consistent with previously reported findings. The company is continuing the analysis of the PREVAIL dataset and evaluating next steps for the development of BNC210 into SAD.

“Although the PREVAIL study did not statistically meet its primary endpoint, we noted the consistent trends in endpoint improvement in BNC210-treated patients and the consistent safety and tolerability profile of BNC210 across the 13 clinical studies conducted to date,” he commented. Errol. De Souza, executive president of Bionomics. “We look forward to welcoming our new President and CEO, Spyridon ‘Spyros’ Papapetropoulos, MD, Ph.D. who has extensive experience in central nervous system clinical development to work with the Bionomics team to lead further analyze data from the PREVAIL study and consult with key opinion leaders and regulators to define next steps for the program. The results indicate that the novel mechanism of action of BNC210 through allosteric modulation of the α7 nicotinic acetylcholine receptor is promising and we remain committed to the ongoing Phase 2b ATTUNE study in PTSD with topline data expected for mid of 2023. The Company’s solid cash position will enable it to achieve these milestones together with the continuation of operations until at least mid-2024″.

About PREVAIL

The study enrolled 151 adult patients diagnosed with SAD and scoring ≥ 70 on the Liebowitz Social Anxiety Scale at 15 sites in the United States. Study participants were randomized 1:1:1 to receive a single oral dose of a placebo or 225mg BNC210 or 675mg BNC210. Following dosing, there was a 55-minute rest period followed by an introduction to the Public Speaking Challenge, a 2-minute advance preparation period, and a 5-minute speech. The primary outcome measure was a self-assessment during the oral challenge using the Subjective Units of Distress Scale (SUDS), a tool for quantifying the intensity of anxiety, fear, or distress on a scale of 0 to 100, with 0 being indicates no distress and 100 representing the highest level. Secondary outcome measures included self-assessment with the State-Trait Anxiety Inventory (STAI), a commonly used measure for trait and state anxiety, and an assessment with the Negative Self-Statements During Public Speaking (SSPS- N).

Learn 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 relationships, cause a person to avoid everyday activities such as dining out and travel, and make normal parts of daily life such as grocery shopping, handyman or harvest coffee challenging.

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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 with severe central nervous system disorders with high unmet medical needs. Bionomics is promoting its lead drug candidate, BNC210, a proprietary oral selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of social anxiety disorder (SAD) and the chronic treatment of PTSD -traumatic (PTSD). In addition to 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 in other central nervous system conditions.

www.bionomics.com.au

Factors affecting future performance

This announcement contains “forward-looking” statements pursuant to US federal securities laws. Any statements contained in this announcement relating to potential events or developments, including, without limitation, statements relating to the Offer, are considered forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “projects,” “forecasts,” “will,” and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual results may differ materially from those discussed in this ASX announcement.

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