Bionomics Reveals Detailed Data From Its Flunked Anxiety Trial, Shows Reductions In Anxiety Across Multiple Phases

  • Bionomics Limited BNOX released a comprehensive analysis of the data from its Phase 2 PREVAIL study to evaluate the efficacy and safety of BNC210 for the acute treatment of Social Anxiety Disorder (SAD). 
  • The company said the data support the late-stage development of BNC210 in SAD.
  • While PREVAIL did not meet its primary endpoint, the December 2022 topline data readout revealed encouraging trends in the prespecified endpoints that focused on individual phases of the public speaking task. 
  • These results supported a post-hoc in-depth analysis of the full dataset to understand better the drug's true potential and guide late-stage trial design.
  • BNC210's therapeutic potential was not limited to a single task phase but was present throughout the speaking task, including the performance phase of the public speaking challenge and the anticipatory period immediately prior. 
  • Administration of 225 mg and 675 mg BNC210 doses resulted in therapeutic responses of similar magnitude.
  • Participants receiving BNC210 experienced significantly less anxiety during the public speaking task (combined resting, anticipation, and performance phases) than participants receiving a placebo.
  • Furthermore, subgroup analyses indicated that the younger participants (below 30 years) showed more robust responses to BNC210 with significant separation from placebo (anticipation and performance) on the SUDS.
  • In addition to the favorable efficacy, the overall safety profile of BNC210 was consistent with a non-sedating anxiolytic. 
  • Price Action: BNOX shares are up 9.89% at $5.11 premarket on the last check Thursday.
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