Where kids of yesteryear might have been labelled shy due to hesitations in social situations, coming generations of children will be classified as having Social Anxiety Disorder as a result of hypervigilant parenting in the digital age. While some will be self-treated via social experimentation, others will struggle without medical intervention which is just one reason the FDA has granted Fast Track designation to biopharmaceutical company Bionomics (ASX: BNO).

The FDA designation has been granted to Bionomics’ lead drug candidate BNC210 which aims to treat acute Social Anxiety Disorder (SAD) and other anxiety-related disorders.

The designation follows a similar assignment by the FDA in November 2019 for the drug’s use to treat Post-Traumatic Stress Disorder (PTSD) and other trauma-related and stressor-related disorders.

Under the latest designation to treat SAD, Bionomics will be granted additional meetings and communications with the FDA with the aim of accelerating its New Drug Application (NDA) for BNC210 as a SAD treatment.

“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, fastacting, 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.”

BNC210 functions by modulating a patient’s α7 nicotinic acetylcholine receptor where it has previously completed a Phase 2a study in Generalised Anxiety Disorder patients who showed significantly reduced threat-avoidance behaviour from a single oral dose.

Building on that data, Bionomics is aiming to commence Phase 2 clinical trials, named the PREVAIL study, to treat SAD patients which the Company is expecting to initiate before the end of 2021. This would then have Bionomics on track to report topline data towards the end of 2022.

As of 30 September 2021, Bionomics had $22.1 million in cash to fund its clinical trial programs.