Bionomics reports ‘promising’ full results analysis from PREVAIL

Bionomics announced the release of a comprehensive analysis of the data from its Phase 2 PREVAIL study to evaluate the efficacy and safety of BNC210, a novel alpha7 nicotinic acetylcholine receptor negative allosteric modulator, for the acute treatment of Social Anxiety Disorder. These data support late-stage development of BNC210 in SAD. The PREVAIL study was designed with the aim of uncovering the best methodological approaches to measure the therapeutic potential of BNC210 in the acute treatment of SAD, a setting with no approved treatments, and evolving understanding of clinical trial methodologies. 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 better understand the true potential of the drug and guide late-stage trial design. This full analysis revealed that 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. Moreover, administration of both 225 mg and 675 mg BNC210 doses resulted in therapeutic responses of similar magnitude, which allowed for the data from the two arms to be combined, enhancing the dataset’s statistical power.