U.S. FDA Grants Bionomics Fast Track Designation to BNC210 for the Acute Treatment of Social Anxiety Disorder and Other Anxiety Related Disorders
Bionomics Limited, a clinical-stage biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has 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 granted Fast Track designation to the BNC210 development program for the treatment of Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders.
Fast Track designation is a FDA program intended to facilitate and expedite development and review of new drugs that demonstrate the potential to address unmet medical need in the treatment of a serious or life-threatening disease or condition. A drug that receives Fast Track designation is eligible for some, or all, of the following:
-more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
-more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers;
-eligibility for priority review and accelerated approval, if relevant criteria are met; and
-possible review of the New Drug Application (NDA) on a rolling basis. NDA review usually does not begin until a company has submitted the entire drug application to the FDA. When an NDA is eligible for rolling review, FDA begins reviewing completed sections of an NDA before the entire NDA is submitted.
BNC210 is an oral proprietary selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor in development for the acute treatment of SAD and chronic treatment of PTSD. Following encouraging results in a previous Phase 2a study in Generalised Anxiety Disorder (GAD) patients where a single oral dose administration of BNC210 showed significantly reduced threat-avoidance behaviour and significantly reduced connectivity between the amygdala and the anterior cingulate cortex, a network involved in regulating anxious 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 expect to initiate by the end of 2021.
The PREVAIL Study is a randomised, double-blind, multi-centre Phase 2 clinical trial which will compare BNC210 to placebo on anxiety levels in patients with SAD during an anxiety-provoking behavioural task such as being asked to speak on a topic. Participants will be orally administered a single dose of study treatment approximately one hour prior to the behavioural task. The proprietary tablet formulation of BNC210 being used in this study is rapidly absorbed and drug levels in the circulation are expected to be around their peak concentrations at the time of the behavioural 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 behavioural task. Secondary objectives include other scales measuring participants' anxiety levels, in anticipation of, and during the behavioural task, as well as an evaluation of the safety and tolerability of BNC210 in this population.
"Anxiety disorders are a significant burden for our communities and approximately 18 million adults suffer from Social Anxiety Disorder in the United States alone. There is no FDA-approved, fast-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 safety concerns. The new oral tablet formulation of BNC210, which is rapidly absorbed and reaches close to maximal concentrations in the blood in approximately one hour, is being evaluated for the acute treatment of SAD patients to better cope with anticipated anxiety-provoking social interactions and other public settings. We look forward to taking advantage of the Fast Track designations for both the SAD and PTSD treatment indications and launching the SAD Phase 2 PREVAIL trial before the end of 2021, with the goal of reporting topline data in late 2022, while continuing recruitment in our ongoing Phase 2 PTSD ATTUNE Study." said Bionomics' Executive Chairman, Dr. Errol De Souza.
Dec 01, 2021
https://www.prnewswire.com/
Fast Track designation is a FDA program intended to facilitate and expedite development and review of new drugs that demonstrate the potential to address unmet medical need in the treatment of a serious or life-threatening disease or condition. A drug that receives Fast Track designation is eligible for some, or all, of the following:
-more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
-more frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers;
-eligibility for priority review and accelerated approval, if relevant criteria are met; and
-possible review of the New Drug Application (NDA) on a rolling basis. NDA review usually does not begin until a company has submitted the entire drug application to the FDA. When an NDA is eligible for rolling review, FDA begins reviewing completed sections of an NDA before the entire NDA is submitted.
BNC210 is an oral proprietary selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor in development for the acute treatment of SAD and chronic treatment of PTSD. Following encouraging results in a previous Phase 2a study in Generalised Anxiety Disorder (GAD) patients where a single oral dose administration of BNC210 showed significantly reduced threat-avoidance behaviour and significantly reduced connectivity between the amygdala and the anterior cingulate cortex, a network involved in regulating anxious 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 expect to initiate by the end of 2021.
The PREVAIL Study is a randomised, double-blind, multi-centre Phase 2 clinical trial which will compare BNC210 to placebo on anxiety levels in patients with SAD during an anxiety-provoking behavioural task such as being asked to speak on a topic. Participants will be orally administered a single dose of study treatment approximately one hour prior to the behavioural task. The proprietary tablet formulation of BNC210 being used in this study is rapidly absorbed and drug levels in the circulation are expected to be around their peak concentrations at the time of the behavioural 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 behavioural task. Secondary objectives include other scales measuring participants' anxiety levels, in anticipation of, and during the behavioural task, as well as an evaluation of the safety and tolerability of BNC210 in this population.
"Anxiety disorders are a significant burden for our communities and approximately 18 million adults suffer from Social Anxiety Disorder in the United States alone. There is no FDA-approved, fast-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 safety concerns. The new oral tablet formulation of BNC210, which is rapidly absorbed and reaches close to maximal concentrations in the blood in approximately one hour, is being evaluated for the acute treatment of SAD patients to better cope with anticipated anxiety-provoking social interactions and other public settings. We look forward to taking advantage of the Fast Track designations for both the SAD and PTSD treatment indications and launching the SAD Phase 2 PREVAIL trial before the end of 2021, with the goal of reporting topline data in late 2022, while continuing recruitment in our ongoing Phase 2 PTSD ATTUNE Study." said Bionomics' Executive Chairman, Dr. Errol De Souza.
Dec 01, 2021
https://www.prnewswire.com/
