Neuphoria Therapeutics Inc. (Nasdaq: NEUP) has achieved target enrollment of 332 participants in its pivotal AFFIRM-1 Phase 3 trial evaluating BNC-210 as a first-in-class, acute treatment for social anxiety disorder (SAD). The clinical-stage biotechnology company announced the milestone on September 4, 2025, with topline data anticipated in early Q4 2025.
"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, M.D., Ph.D., 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."
Novel Mechanism of Action
BNC-210 represents a novel approach to anxiety treatment as an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor. The drug candidate is being developed for both acute treatment of SAD and chronic treatment of post-traumatic stress disorder (PTSD). BNC-210 has received FDA Fast Track designation for acute treatment of SAD and other anxiety-related disorders, as well as for treatment of PTSD and other trauma and stressor-related disorders.
The therapeutic has demonstrated rapid-onset, broad and meaningful anti-anxiety effects in completed clinical trials across multiple anxiety conditions, including SAD, generalized anxiety disorder (GAD) and panic attacks. Notably, these effects occurred without evidence of sedation, cognitive impairments, or addiction potential—common limitations of existing anxiety treatments.
AFFIRM-1 Trial Design
The AFFIRM-1 Phase 3 clinical trial employs a multi-center, double-blind, two-arm, parallel group, placebo-controlled design to evaluate the safety and efficacy of a single, acute 225 mg dose of BNC-210 versus placebo. Participants are randomized 1:1 to receive either the active treatment or matched placebo.
The trial incorporates a unique public speaking challenge methodology. Approximately one hour after dosing, participants are introduced to a public speaking task, given two minutes to prepare for their speech (anticipation phase), and then deliver a five-minute speech in front of a small audience (performance phase). This design allows researchers to assess the drug's effectiveness in a controlled, anxiety-provoking situation that mirrors real-world social anxiety triggers.
The primary endpoint measures the change from baseline to the average of the performance phase using Subjective Units of Distress Scale (SUDS) scores. Secondary endpoints include SUDS score changes during the anticipation phase, Clinical Global Impression – Severity (CGI-S) scale changes, and self-assessments using the State Trait Anxiety Inventory (STAI-State) and Patient Global Impression – Improvement (PGI-I) scale. A follow-up visit occurs one week after the public speaking challenge.
Addressing Significant Unmet Need
Social anxiety disorder represents one of the most common mental disorders in the United States, with an estimated 31 million Americans expected to suffer from SAD at some point in their lives. The condition is characterized by significant and persistent fear of social and performance-related situations, substantially impacting patients' quality of life.
SAD can interfere with a person's ability to work, maintain relationships, and participate in everyday activities. The disorder makes it difficult to maintain friendships, family relationships, and romantic partnerships, while causing individuals to avoid lifestyle activities like dining out and traveling. Even routine tasks such as grocery shopping, calling service providers, or ordering coffee can become challenging for those affected by the condition.
Broader Pipeline Development
Beyond BNC-210, Neuphoria maintains a strategic partnership with Merck & Co., Inc. involving two drugs in early-stage clinical trials for treating cognitive deficits in Alzheimer's disease and other central nervous system conditions. The company's pipeline also includes next-generation α7 nicotinic acetylcholine receptor programs and Kv3.1/3.2 preclinical programs, both currently in lead optimization development stages.
BNC-210 is designed as a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic that aims to restore neurotransmitter balance in relevant brain areas. This mechanism provides rapid relief from stress and anxiety symptoms while avoiding common treatment limitations including sedation, cognitive impairment, and addiction potential.
