Bionomics (ASX:BNO) has announced the results from its Phase 2 randomised, double-blind, placebo-controlled, multi-centre, dose-ranging PREVAIL study to evaluate the safety, tolerability, and efficacy of BNC210 for the acute treatment of Social Anxiety Disorder (SAD).
BNC210 has a novel mechanism of action that involves negative allosteric modulation of the α7 nicotinic acetylcholine receptor.
The company said the study’s primary endpoint as measured by the change from baseline to the average of the Subjective Units of Distress Scale (SUDS) scores during a five-minute Public Speaking Challenge was not met in the BNC210-treated patients when compared to placebo.
However, it said 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.
The company said it is continuing its analysis of the PREVAIL dataset and is assessing the next steps for the development of BNC210 in SAD.
“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,” said executive chairman Errol De Souza.
“We look forward to welcoming our new President and CEO, Spyridon ‘Spyros’ Papapetropoulos, who has extensive experience in CNS clinical development to work with the Bionomics team to conduct further analysis on the PREVAIL Study data and consult with key opinion leaders and regulators in order to define next steps for the program.
“The findings indicate that BNC210’s novel mechanism of action through allosteric modulation of the α7 nicotinic acetylcholine receptor is promising and we remain committed to the ongoing Phase 2b ATTUNE Study in PTSD with topline data expected mid-2023. The strong cash position of the Company will enable delivery of these milestones along with continuing operations to at least mid-2024.”
