Target Enrollment Completed for Phase 3 AFFIRM-1 Trial of BNC-210 in Social Anxiety Disorder

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Neuphoria Therapeutics today announced the achievement of target enrollment of 332 participants in the AFFIRM-1 phase 3 trial that will evaluate the lead candidate BNC-210 as a first-in-class, acute, as-needed, fast-acting treatment for social anxiety disorder (SAD).¹

“We are thrilled to reach our target enrollment in the AFFIRM-1 trial evaluating BNC-210 as a transformative therapeutic for the treatment of SAD,” said Spyros Papapetropoulos, MD, PhD, president and CEO of Neuphoria. “Achieving this milestone puts us on a clear path toward our first phase 3 data for BNC-210, now expected early in the fourth quarter.”

BNC-210 is an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the treatment of SAD and posttraumatic stress disorder (PTSD). The US Food and Drug Administration granted BNC-210 Fast Track designation for acute treatment of SAD and other anxiety related disorders in December 2021, and for treatment of PTSD and other trauma and stressor related disorders in November 2019.² In clinical trials, BNC-210 has demonstrated rapid-onset, broad, and meaningful anti-anxiety effects in SAD, generalized anxiety disorder, and panic attacks without evidence of sedation, impairments in cognition, or potential for addiction.

The AFFIRM-1 phase 3 clinical trial is a multi-center, double-blind, 2-arm, parallel group, placebo-controlled trial evaluating the safety and efficacy of a single, acute dose of 225 mg of BNC-210 vs placebo. Trial participants are randomized 1:1 to receive a single dose of 225 mg BNC-210 or matched placebo. Approximately 1 hour after dosing, participants are given a public speaking challenge and have 2 minutes to prepare for the speech (anticipation phase) before delivering a 5-minute speech in front of a small audience (performance phase). The primary endpoint of the trial is the change from baseline to the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale (SUDS) scores. Secondary endpoints include change in SUDS score from baseline to the average of the anticipation phase, changes in the Clinical Global Impression – Severity scale, and self-assessment with the State Trait Anxiety Inventory and the Patient Global Impression – Improvement scale. A follow-up visit occurs 1 week after the public speaking challenge.

This trial builds upon the work of the PREVAIL study, a phase 2 study evaluating the potential of 225 mg and 675 mg BNC-210 in patients with SAD. Investigators evaluated anxiety via self-report efficacy scales during the anticipation and performance phases of a simulated public speaking challenge. Least squares mean ± standard error differences compared with placebo for the SUDS scores for the change from baseline to the average of the performance phase were -6.6 ± 4.75 for 225 mg BNC-210 and -4.8 ± 4.73 for 675 mg BNC-210 (not significant). A post hoc analysis of SUDS scores evaluating combined BNC-210 doses and speaking challenge phases (anticipation and performance) revealed a nominally statistically significant reduction compared with placebo (P = 0.044; effect size 0.36). Results supported further testing of 225 mg BNC-210 as a potential safe and effective anxiolytic for acute, as-needed treatment of SAD.³

References

1. Neuphoria Therapeutics Completes Target Enrollment in Phase 3 AFFIRM-1 Trial of BNC-210 in Social Anxiety Disorder (SAD). News release. September 4, 2025. Accessed September 4, 2025. https://www.biospace.com/press-releases/neuphoria-therapeutics-completes-target-enrollment-in-phase-3-affirm-1-trial-of-bnc-210-in-social-anxiety-disorder-sad

2. U.S. FDA grants Bionomics Fast Track designation to BNC210 for the acute treatment of social anxiety disorder and other anxiety related disorders. News release. December 1, 2021. Accessed September 4, 2025. https://www.prnewswire.com/news-releases/us-fda-grants-bionomics-fast-track-designation-to-bnc210-for-the-acute-treatment-of-social-anxiety-disorder-and-other-anxiety-related-disorders-301434695.html 

3. Papapetropoulos S, Doolin E, Odontiadis M, et al. 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. Psychiatry Res. 2025:346:116387.