Neuphoria Therapeutics achieves target enrollment in AFFIRM-1 Phase 3 trial for BNC-210.

Neuphoria Therapeutics has reached target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial for its lead candidate BNC-210, a treatment for social anxiety disorder. The trial aims to evaluate BNC-210 as a fast-acting, "as needed" treatment. The company expects to announce Phase 3 data early in Q4. BNC-210 is a proprietary, oral, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor.

Neuphoria Therapeutics Inc. (Nasdaq: NEUP) has successfully reached its target enrollment of 332 participants in the Phase 3 AFFIRM-1 trial for its lead candidate BNC-210. The trial aims to evaluate BNC-210 as a fast-acting, "as needed" treatment for social anxiety disorder (SAD). The company expects to announce Phase 3 data early in the fourth quarter of 2025 [1].

BNC-210 is an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor under development for the treatment of SAD and post-traumatic stress disorder (PTSD). It has been granted FDA Fast Track designation for the acute treatment of SAD and other anxiety-related disorders, as well as for PTSD and other trauma and stressor-related disorders [1].

The AFFIRM-1 Phase 3 clinical trial is a multi-center, double-blind, two-arm, parallel group, placebo-controlled study. Participants are randomized 1:1 to receive a single, acute dose of 225 mg of BNC-210 or matched placebo. Approximately one hour after dosing, participants are introduced to a public speaking challenge and have two minutes to prepare for the speech (anticipation phase) before delivering a five-minute speech in front of a small audience (performance phase) [1].

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 (CGI-S) scale, and self-assessment with the State Trait Anxiety Inventory (STAI-State) and the Patient Global Impression – Improvement (PGI-I) scale. A follow-up visit occurs one week after the public speaking challenge [1].

Social anxiety disorder (SAD) is a significant and persistent fear of social and performance-related situations, affecting an estimated 31 million Americans at some point in their lives [1]. SAD can interfere with a person’s ability to work, maintain relationships, and participate in everyday activities.

Neuphoria Therapeutics is a clinical-stage biotechnology company dedicated to developing therapies for neuropsychiatric disorders. The company is advancing BNC-210 for the acute, "as needed" treatment of SAD and chronic treatment of PTSD. BNC-210 is designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without sedation, cognitive impairment, or addiction potential [1].

The company has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Neuphoria’s pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs [1].

Neuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. The forward-looking statements are based on current beliefs, plans, burn rate, and expectations. Certain forward-looking statements, including (without limitation) about Neuphoria’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement and/or completion of various clinical trials and receipt of data, and current and future collaborations for the development and commercialization of its product candidates, are qualified in their entirety by this cautionary statement [1].

References:
[1] https://www.globenewswire.com/news-release/2025/09/04/3144309/0/en/Neuphoria-Therapeutics-Completes-Target-Enrollment-in-Phase-3-AFFIRM-1-Trial-of-BNC-210-in-Social-Anxiety-Disorder-SAD.html