Bionomics reports updated analysis from PREVAIL Phase 2 Study of BNC210

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Bionomics (ASX:BNO) has announced the release of an analysis of the data from its Phase 2 PREVAIL study evaluating the efficacy and safety of BNC210 for the treatment of acute Social Anxiety Disorder (SAD).

BNC210 is a novel α7 nicotinic acetylcholine receptor-negative allosteric modulator.

The company said 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.

Is said that 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.

"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," it said.

"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, placebo n = 50)."

"Participants that received BNC210 experienced significantly less anxiety during the public speaking task (combined resting, anticipation, and performance phases) compared to participants that received placebo as measured by the Subjective Units of Distress Scale (SUDS), the study’s primary outcome measure (p=0.037)," said the company.

"Similar results were observed when combining the two high-anxiety phases (anticipation and performance, p=0.044). These therapeutic effects are comparable to those reported with benzodiazepines supporting the clinical meaningfulness of BNC210’s anxiolytic effects."

The company said will share details on PREVAIL during a webcast and plans to discuss results and the overall design of the registrational program with the FDA in the coming months.