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Bionomics Reports Promising Full Results Analysis from PREVAIL Phase 2 Study of BNC210 Social Anxiety Disorder (SAD)
Both doses of BNC210 as an acute treatment resulted in reductions in anxiety across multiple phases of the public speaking challengeResults achieved
About this update from Neuphoria Therapeutics Inc.
[{"type":"text","content":"Both doses of BNC210 as an acute treatment resulted in reductions in anxiety across multiple phases of the public speaking challengeResults achieved statistical significance in post-hoc analysis of the full data set and in relevant subpopulations Favourable safety, tolerability and PK findings are consistent with a fast-acting non-sedating anxiolytic profileThe company is planning an End of Phase 2 (EoPh2) meeting to discuss BNC210’s late-stage SAD program 2H 2023 Webcast and conference call scheduled for Thursday, March 9, 2023 at 8:00 AM EST (Friday, March 10, 2023 at 12:00 AM AEDT) ADELAIDE, Australia, March 08, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators for serious central nervous system (CNS) disorders with high unmet medical need, today 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 α7 nicotinic acetylcholine receptor negative allosteric modulator, for the acute treatment of Social Anxiety Disorder (SAD). 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 (BNC210 n = 101, ...