The Food and Drug Administration (FDA) has granted Fast Track designation to BNC210 for the acute treatment of social anxiety disorder (SAD) and other anxiety-related disorders.

BNC210 is an oral selective negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor. The designation is supported by data from a phase 2a study which evaluated a single oral dose administration of BNC210 in patients with generalized anxiety disorder. Findings showed that treatment with BNC210 significantly reduced threat-avoidance behavior and reduced connectivity between the amygdala and the anterior cingulate cortex.

The Company will evaluate BNC210 in patients with SAD in the multicenter, randomized, double-blind, placebo-controlled phase 2 PREVAIL trial, which is expected to begin by the end of 2021. Patients will receive a single oral dose of BNC210 approximately 1 hour prior to the behavioral task. The primary endpoint will be self-reported anxiety levels using the Subjective Units of Distress Scale during the behavioral task.

“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 1 hour, is being evaluated for the acute treatment of SAD patients to better cope with anticipated anxiety-provoking social interactions and other public settings.”

The FDA previously granted Fast Track designation to BNC210 for the treatment of post-traumatic stress disorder (PTSD) and other trauma-related and stressor-related disorders.

Reference

US FDA grants Bionomics Fast Track designation to BNC210 for the acute treatment of social anxiety disorder and other anxiety related disorders. News release. Bionomics Limited. Accessed December 1, 2021. https://www.prnewswire.com/news-releases/us-fda-grants-bionomics-fast-track-designation-to-bnc210-for-the-acute-treatment-of-social-anxiety-disorder-and-other-anxiety-related-disorders-301434695.html