The trial will enrol nearly 330 adults with social anxiety disorder at various trial sites in the US. Credit: Ground Picture / Shutterstock.

Bionomics has commenced the screening of subjects for the Phase III AFFIRM-1 clinical trial of BNC210 for acute, as-needed social anxiety disorder (SAD) treatment.

The multicentre, two-arm, double-blind, parallel group, placebo-controlled trial will evaluate the safety and efficacy of BNC210 oral tablets against a placebo.

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It will enrol nearly 330 adults with SAD at various trial sites in the US.

Trial subjects will be randomised into a 1:1 ratio to receive a single acute dose of BNC210 225mg or a placebo nearly an hour before public speaking.

The change from baseline in subjective units of distress scale (SUDS) scores to the average of the public speaking challenge’s performance phase is the trial’s primary endpoint.

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Secondary endpoints include self-evaluation using the State-Trait Anxiety Inventory (STAI, State subscale) and the Patient-Global Impression-Improvement (PGI-I) scale, variation in the Clinical Global Impression-Severity (CGI-S) scale, and changes in the SUDS score from baseline to the anticipation phase average.

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The findings of the complete data analysis of the Phase II PREVAIL trial and the agreement achieved during the End-of-Phase II discussion with the US Food and Drug Administration (FDA) in the third quarter of 2023 led to the launch of the AFFIRM-1 trial.

Apart from SAD, BNC210 is said to have demonstrated potential in lowering anxiety levels in general anxiety disorder, reducing the intensity of all symptoms in post-traumatic stress disorder, and panic symptoms in panic episodes that are pharmacologically caused.

Bionomics president and CEO Spyros Papapetropoulos said: “AFFIRM-1 trial initiation marks a major achievement for Bionomics as we enter the Phase Iii clinical stage, made possible by our recent capital raise and our expert clinical development team that has a proven track record of executing high quality trials on time and within budget.

“The Phase III study expands on the findings of the Phase III PREVAIL trial and brings us closer to potentially transforming the treatment paradigm for the millions of individuals who lack safe and effective acute, as-needed treatment options to assist them in facing anxiety-inducing situations.”