Bionomics, a clinical-stage biotechnology company, has received support from the U.S. Food and Drug Administration (FDA) for the Phase 3 trial of its groundbreaking treatment for Social Anxiety Disorder (SAD). The company announced the successful outcomes of its End-of-Phase 2 meeting with the FDA, which validated the strength of its Phase 2 dataset.
Bionomics has developed BNC210, a first-in-class allosteric ion channel modulator, to treat patients suffering from serious central nervous system disorders. The drug has shown promise in treating various anxiety disorders, including SAD, Generalized Anxiety Disorder, and Post-Traumatic Stress Disorder (PTSD). It has also received Fast-Track designation from the FDA for the acute treatment of SAD.
During the meeting, Bionomics reached an agreement with the FDA on key elements of the Phase 3 trial design. The company plans to conduct two randomized, placebo-controlled studies using BNC210 in a public speaking task. The primary efficacy endpoint will be measured using the Subjective Units of Distress Scale (SUDS). The doses of BNC210 to be studied in Phase 3, as well as the sample size assumptions based on the Phase 2 PREVAIL findings, were also agreed upon.
In addition, the FDA supported the design elements of an open label safety study required for the new drug application (NDA), as well as the size of the safety database and the nonclinical toxicology studies needed to support the NDA. With these agreements in place, Bionomics is set to begin its Phase 3 program in the first quarter of 2024.
The positive outcomes of the FDA meeting provide external validation of BNC210’s clinical profile and its potential to address the unmet need for fast-acting and safe treatments for the millions of Americans suffering from SAD. Bionomics aims to offer a novel therapeutic option to improve the lives of patients with this debilitating disorder.
Bionomics is a leading clinical-stage biotechnology company focused on developing innovative treatments for CNS disorders with high unmet medical needs. Aside from BNC210, the company has a strategic partnership with MSD to develop drugs for cognitive deficits in Alzheimer’s disease and other CNS conditions. Bionomics also has preclinical assets targeting ion channels for CNS disorders.
With the FDA’s support for the Phase 3 trial of its groundbreaking SAD treatment, Bionomics is one step closer to providing an effective and much-needed solution for individuals suffering from this debilitating disorder. The company’s commitment to advancing therapeutic options for CNS disorders underscores its dedication to improving patient outcomes and quality of life.
