Bionomics gets FDA greenlight for mid-stage BNC210 Social Anxiety Disorder study

Headquarters of US Food and Drug Administration (FDA)

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  • Bionomics Limited (OTCQB:BNOEF) has received U.S. FDA clearance to proceed with evaluating its lead clinical compound, BNC210, for the acute treatment of Social Anxiety Disorder (SAD) in a Phase 2 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 study is a randomised, double-blind, multi-centre trial which 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 is to compare BNC210 to placebo on self-reported anxiety levels using the Subjective Units of Distress Scale (SUDS) during the behavioural task.
  • The company is targeting commencement of the trial by the end of this year and expects to report topline data by the end of 2022.

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