US FDA grants new fast designation for Bionomics’ BNC210

Bionomics (ASX:BNO) has announced that the US 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 an FDA program intended to facilitate and expedite the development and review of new drugs that demonstrate the potential to address an unmet medical need in the treatment of a serious or life-threatening disease or condition.

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.

The company said that following encouraging results in a previous Phase 2a study in Generalised Anxiety Disorder (GAD) patients, 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.

The PREVAIL study is a randomised, double-blind, multi-centre Phase 2 clinical trial that 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.

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,” said Bionomics’ executive chairman Dr Errol De Souza.

“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.”

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