ADÃLAIDEDE, Australia, December 1, 2021 / PRNewswire / – Limited bionomics (ASX: BNO, OTCQB: BNOEF) (Bionomy Where Society), a clinical-stage biopharmaceutical company, is pleased to announce that the US Food and Drug Administration (FDA) granted Fast Track designation to the BNC210 development program for the acute treatment of social anxiety disorder (SAD) and other anxiety-related disorders. In november 2019, the FDA has granted Fast Track designation to the BNC210 development program for the treatment of post-traumatic stress disorder (PTSD) and other trauma and stressor-related disorders.
The Fast Track designation is an FDA program intended to facilitate and expedite the development and review of new drugs that demonstrate the potential to meet unmet medical needs in the treatment of serious illness or disease or potentially fatal. A drug that receives the Fast Track designation is eligible for some or all of the following:
- more frequent meetings with the FDA to discuss the drug development plan and ensure the collection of the appropriate data needed to support drug approval;
- more frequent written communications from the FDA on topics such as the design of proposed clinical trials and the use of biomarkers;
- eligibility for priority review and expedited approval, if the relevant criteria are met; and
- possible review of the New Drug Application (NDR) on an ongoing basis. The NDA review typically does not begin until a company has submitted the entire drug application to the FDA. When an NDA is eligible for ongoing review, the FDA begins reviewing completed sections of an NDA before the entire NDA is submitted.
BNC210 is a proprietary oral selective negative allosteric modulator of the Î±7 nicotinic acetylcholine receptor in development for the acute treatment of SAD and chronic treatment of PTSD. Following encouraging results from a previous phase 2a study in patients with generalized anxiety disorder (GAD) where a single oral dose of BNC210 showed significantly reduced threat avoidance behavior and significantly reduced connectivity between l amygdala and anterior cingulate cortex, a network involved in the regulation of anxiety responses to aversive stimuli, BNC210 will be evaluated as an acute, or single-dose, treatment for patients with SAD in a planned phase 2 clinical trial named the PREVAIL study that we plan to launch by the end of 2021.
The PREVAIL study is a multicenter, randomized, double-blind, Phase 2 clinical trial that will compare BNC210 to placebo on anxiety levels in patients with SAD during an anxiety-inducing behavior task, such as than being invited to speak on a topic. Participants will be given a single oral dose of study treatment approximately one hour before the behavior task. The proprietary formulation of BNC210 tablets used in this study are rapidly absorbed and drug levels in the circulation are expected to be around their peak concentrations at the time of the behavioral task. The primary objective of the study is to compare BNC210 to placebo on self-reported anxiety levels using the Subjective Units of Distress Scale (SUDS) during the behavioral task. Secondary objectives include further scales measuring participants’ anxiety levels in anticipation and during the behavioral task, as well as an assessment of the safety and tolerability of BNC210 in this population.
âAnxiety disorders represent a significant burden on our communities and an estimated 18 million adults suffer from social anxiety disorders in United States alone. There is no FDA-approved, quick-acting, as-needed treatment for SAD and the current standard of care, FDA-approved antidepressants and off-label use of benzodiazepines, have significant potential side effects and symptoms. security concerns. The new oral tablet formulation of BNC210, which is rapidly absorbed and reaches concentrations near peak blood levels in about an hour, is being evaluated for the acute treatment of patients with SAD to better cope with the anticipated anxiety-inducing social interactions and other public places. . We look forward to leveraging the Fast Track designations for the SAD and PTSD treatment indications and launching the PREVAIL Phase 2 SAD trial before the end of 2021, with the goal of reporting baseline data in late 2022, while continuing to recruit into our Phase 2 PTSD ATTUNE Study, âsaid Bionomics Executive Chairman Dr. Errol De Souza.
Released on authorization from the Executive Chairman.
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About Bionomics Limited
Bionomics (ASX: BNO, OTCQB: BNOEF) is a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators designed to transform the lives of patients with severe central nervous system (âCNSâ) disorders with medical need high not satisfied. Bionomics Advances Its Lead Product Candidate BNC210, a Selective and Proprietary Oral Negative Allosteric Acetylcholine Receptor Î±7 Modulator, for the Acute Treatment of Social Anxiety Disorder (“SAD”) and Chronic Treatment of Stress Disorder post-traumatic stress disorder (“PTSD”). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside 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.
Factors Affecting Future Performance
This announcement contains “forward-looking” statements within the meaning of United States’ Private Securities Litigation Reform Act of 1995. All statements contained in this announcement that relate to potential events or developments, including, without limitation, statements made regarding Bionomics’ drug candidates (including BNC210), programs drug discovery, ongoing and future clinical trials, and the timing of receipt of clinical data for our drug candidates 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 such forward-looking statements, including unexpected safety or efficacy data, unexpected side effects observed in trials clinical, risks associated with our available funds or funding arrangements, our inability to introduce new drug candidates or obtain regulatory approvals in a timely manner or not at all, regulatory changes, failure to protect our intellectual property, risks associated with our international operations, as well as other factors. Results from studies of our drug candidates and competing drugs and drug candidates may differ from those reported when tested in different settings.
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SOURCE Bionomics Limited
Company codes: Australia: BNO, OTC-BB: BNOEF, OTC-BB: BNOEF.OB, OTC-ROSE: BNOEF