Bionomics Ltd. (BNOX), a clinical-stage biopharmaceutical company focused on serious central nervous system or CNS disorders, announced that its PREVAIL Phase 2 Study of BNC210 in social anxiety disorder or SAD failed to meet primary endpoint.<\/p>\n
However, the findings do indicate a consistent trend toward improvements across primary and secondary endpoints and a favourable safety and tolerability profile consistent with previously reported results, it said.<\/p>\n
The company is continuing analysis of the data and evaluating next steps for the development of BNC210 in SAD, with cash runway into mid-2024.<\/p>\n
SAD is a significant and persistent fear of social and performance-related situations.<\/p>\n
Bionomics noted that BNC210 has a novel mechanism of action that involves negative allosteric modulation of the a7 nicotinic acetylcholine receptor.<\/p>\n
The Phase 2 randomised, double-blind, placebo-controlled, multi-centre, dose-ranging PREVAIL study evaluated the safety, tolerability, and efficacy of BNC210 for the acute treatment of SAD.<\/p>\n
In the trial, the primary endpoint as measured by the change from baseline to the average of the Subjective Units of Distress Scale or SUDS scores during a 5-minute Public Speaking Challenge was not met in the BNC210-treated patients when compared to placebo.<\/p>\n
Errol De Souza, Executive Chairman of Bionomics, said, “Although the PREVAIL study did not statistically meet its primary endpoint, we have noted the consistent trends in improvement of endpoints in the BNC210-treated patients and continued strong safety and tolerability profile of BNC210 across the 13 clinical trials conducted to date.<\/p>\n
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