A phase 2, placebo-controlled study to evaluate the efficacy and safety of BNC210, an alpha-7 nicotinic receptor negative allosteric modulator, for acute, as-needed treatment of social anxiety disorder (SAD) – The PREVAIL study

Social anxiety disorder (SAD) is a chronic, debilitating, and prevalent neuropsychiatric condition for which an acute, as-needed therapy is an unmet medical need. This Phase 2 study evaluated a potential novel, fast-acting, anxiolytic, BNC210, in SAD patients (NCT05193409). PREVAIL was a placebo-controlled, acute dose study of 225 mg and 675 mg BNC210 in 151 adult participants with SAD. Anxiety was evaluated by self-report efficacy scales during the anticipation and performance phases of a simulated public speaking challenge. Safety data were collected. Least squares mean ± standard error (SE) differences compared to placebo for the Subjective Units of Distress Scale (SUDS) scores for the change from baseline to the average of the performance phase were -6.6 ± 4.75 for 225 mg BNC210 and -4.8 ± 4.73 for 675 mg BNC210 (not significant). A post hoc analysis of SUDS scores evaluating combined BNC210 doses and speaking challenge phases (anticipation and performance) revealed a nominally statistically significant reduction compared to placebo (p = 0.044; effect size 0.36). Both dose levels of BNC210 demonstrated a favorable safety profile. PREVAIL supported further testing of 225 mg BNC210 as a potential safe and effective anxiolytic for acute, as-needed treatment of SAD. A Phase 3 trial is ongoing.