Bionomics Prepares BNC210 for Start of Phase 2 Acute Treatment of Social Anxiety Disorder Trial

• Rapid oral absorption of BNC210 novel tablet formulation potentially well-suited for acute treatment of anxiety in patients with Social Anxiety Disorder
• Phase 2 clinical trial on target to start by end of 2021 and expected to read out topline data by end of 2022

ADELAIDE, Australia, Sept. 20, 2021 /PRNewswire/ -- Bionomics Limited (ASX: BNO, OTCQB:BNOEF) (Bionomics or Company), a clinical-stage biopharmaceutical company, is pleased to announce that as part of its broader pipeline expansion strategy and based on anti-anxiety signals in Generalised Anxiety Disorder (GAD) patients, it has decided to proceed with evaluating its lead clinical compound, BNC210, for acute treatment of Social Anxiety Disorder (SAD) with a planned commencement of a clinical trial by the end of this year.

BNC210 is an oral proprietary selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor in development for the treatment of anxiety and trauma- and stressor-related disorders. A previous in-clinic Phase 2a study in GAD patients demonstrated that single dose administration of the liquid suspension formulation of BNC210 showed significant anti-anxiety signals as measured in brain imaging and behavioural studies, but without evidence of sedation or addictive potential. However, the slow absorption of the liquid suspension formulation of BNC210 and the requirement for it to be taken with food for optimal absorption, would limit its use in "real world" situations for the acute treatment of anxiety. A new solid dose tablet formulation of BNC210 has been developed showing much improved and rapid absorption and we plan to use the tablet formulation for the Phase 2 acute treatment clinical trial in SAD patients.

The Phase 2 SAD trial protocol has been developed with input from Bionomics' Clinical Advisory Board members and will compare BNC210 to placebo on anxiety levels using the Subjective Units of Distress Scale (SUDS) during an anxiety-provoking behavioural task following a single dose treatment with the study drug. Drug product has already been manufactured and study start-up activities are underway. It is anticipated that approximately 15 sites in the U.S. will be involved in the trial, recruiting approximately 150 patients suffering with SAD. We intend to submit an Investigational New Drug (IND) application to the U.S. FDA in time for the commencement of the study by the end of this year, if the IND goes into effect with the FDA.

"Anxiety disorders are a significant burden for our communities and approximately 18 million American adults suffer from Social Anxiety Disorder in the U.S. alone. There is no FDA-approved, fast-acting, as-needed treatment for SAD and current standard of care FDA-approved antidepressants and off-label use of benzodiazepines have significant potential side effects and safety concerns. The new oral tablet formulation of BNC210 which is rapidly absorbed and reaches maximal concentrations in the blood in approximately 45 to 105 minutes may be well-suited for the acute treatment of SAD patients to better cope with anticipated anxiety-provoking social interactions and other public settings. We look forward to launching the SAD trial while continuing recruitment in our ongoing BNC210 Phase 2b Post-Traumatic Stress Disorder ATTUNE study with the goal of reporting topline data from the trials in late 2022 and the first half of 2023, respectively," said Bionomics' Executive Chairman, Dr. Errol De Souza.

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About Bionomics Limited

Bionomics (ASX: BNO, OTCQB: BNOEF) is a clinical-stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best-in-class, novel drug candidates for patients affected by central nervous system (CNS) disorders. Bionomics' lead drug candidate BNC210 is a negative allosteric modulator of the α7 nicotinic acetylcholine receptor. BNC210 oral tablet formulation is currently being evaluated in a second Phase 2b trial for the treatment of Post-Traumatic Stress Disorder (PTSD) for which it was granted Fast Track designation by the FDA. BNC210 is also being evaluated as an acute treatment in Social Anxiety Disorder (SAD) patients and is expected to enter a Phase 2 trial. In addition, Bionomics has entered into a Memorandum of Understanding with EmpathBio Inc, a wholly owned subsidiary of Germany-based CNS clinical development company, atai Life Sciences, to collectively explore a combination drug treatment regimen with Bionomics' BNC210 and EmpathBio's 3,4- Methylenedioxymethamphetamine (MDMA) derivative EMP-01 for the treatment of 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.www.bionomics.com.au^[1] 

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References

1. ^{^} www.bionomics.com.au (www.bionomics.com.au)
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