Bionomics Reports Major Results in the Phase 2 PREVAIL Study of BNC210 in Social Anxiety Disorder

Bionomics Ltd

  • BNC210 for the treatment of social anxiety disorder (SAD) did not meet the primary endpoint

  • Subjects with confirmed SAD receiving BNC210 exhibited trends toward improvements in all endpoints compared to placebo.

  • BNC210 Demonstrated favorable profile of safety and tolerability consistent with previous experience

  • The company continues with the analysis of the data and evaluates the next steps with the Cash Runway until mid-2024

ADELAIDE, Australia, December 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 lives of patients with severe central nervous system (CNS) disorders with high unmet medical need, today announced the results of its Phase 2 randomized, double-blind, placebo-controlled, multicenter, dose-ranging study of PREVAIL 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 that involves negative allosteric modulation of the α7 nicotinic acetylcholine receptor. Although the primary endpoint measured by the change from baseline to mean Subjective Units of Distress Scale (SUDS) scores during a 5-minute public speaking challenge was not met in patients treated with BNC210. Compared to placebo, the findings do not indicate a consistent trend toward improvements in primary and secondary endpoints and a favorable safety and tolerability profile consistent with previously reported results. The Company is continuing with the analysis of the PREVAIL dataset and is evaluating the next steps for the development of BNC210 in SAD.

“Although the PREVAIL study did not statistically meet its primary endpoint, we have noted consistent trends in endpoint improvement in patients treated with BNC210 and the continued strong safety and tolerability profile of BNC210 across the 13 clinical trials. done to date,” Errol said. De Souza, CEO of Bionomics. “We look forward to welcoming our new President and CEO, Spyridon ‘Spyros’ Papapetropoulos, MD, Ph.D. who has extensive experience in CNS clinical development to work with the bionomics team to conduct a more detailed analysis of the PREVAIL study data and consult with key thought leaders and regulators to define next steps for the program. The findings 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 first-line data expected by mid-2023. The Company’s strong cash position will enable it to meet these milestones along with continued operations at least through mid-2024.”

About PREVAIL

The trial enrolled 151 adult patients with SAD diagnosed and scoring ≥70 on the Liebowitz Social Anxiety Scale at 15 sites in the US. Study participants were randomized 1:1:1 to receive a single oral dose of a placebo or 225mg BNC210 or 675mg BNC210. After dosing, there was a 55-minute rest period followed by an introduction to the public speaking challenge, a 2-minute anticipation and preparation period, and a 5-minute speech. The primary outcome measure was a self-assessment during the speech 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, where 0 indicates that there is 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 of trait and state anxiety, and assessment with the Negative Self-Statements During Public Speaking (SSPS-N) subscale.

About social anxiety disorder

SAD is a significant and persistent fear of performance-related and social situations. One of the most common mental disorders in the United States, an estimated 31 million Americans will experience 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 associations, cause a person to avoid lifestyle activities such as dining out and traveling, and make normal parts of life such as shopping, calling a handyman, or picking up a challenging coffee.

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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 CNS disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, a patented 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 post-traumatic stress disorder ( PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside of 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 conditions of the central nervous system. .

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Factors Affecting Future Performance

This announcement contains “forward-looking” statements within the meaning of US federal securities laws. All statements contained in this announcement that relate to possible events or developments, including, without limitation, statements relating to the Offering, forward-looking statements are considered. 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 in these forward-looking statements. The Company does not undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual results could differ materially from those discussed in this ASX announcement.

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