US FDA clears Bionomics' new clinical trial of BNC210

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Bionomics (ASX:BNO) has received US FDA clearance to proceed with evaluating its lead clinical compound, BNC210, for the acute treatment of Social Anxiety Disorder (SAD) in a Phase 2 clinical trial.

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 Post-Traumatic Stress Disorder (PTSD).

The company said the new trial, the PREVAIL Study, will evaluate BNC210 as an acute, or single-dose, treatment for patients with SAD.

The 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.

Participants will be orally administered a single dose of study treatment approximately one hour prior to the behavioural task.

The primary objective 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 the anxiety levels of participants, in anticipation of, and during the behavioural task, as well as an evaluation of the safety and tolerability of BNC210.

"Anxiety disorders are a significant burden for our communities and approximately 18 million adults suffer from Social Anxiety Disorder in the United States alone," said Bionomics executive chairman Dr Errol De Souza.

"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 is expected to reach maximal concentrations in the blood in approximately 45 to 105 minutes 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 launching the SAD trial while continuing recruitment in our ongoing Phase 2b ATTUNE study for BNC210 for the treatment of Post-Traumatic Stress Disorder with the goal of reporting topline data from these trials in late 2022 and the first half of 2023, respectively.”