Social Anxiety Disorder - National Institute of Mental Health (NIMH)
Social anxiety disorder (formerly social phobia) is characterized by persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. The individual fears that he or she will act in a way (or show anxiety symptoms) that will be embarrassing and humiliating.
Read More
- Study Design: AFFIRM-1 is a multi-center, double-blind, placebo-controlled trial targeting 330 adult patients with SAD in the U.S. Participants will receive a single dose of 225 mg BNC210 or placebo before a public speaking task.
- Primary Endpoint: The trial will use the Subjective Units of Distress Scale (SUDS) to measure self-reported anxiety levels during public speaking, comparing BNC210 to placebo.
- Secondary Endpoints: Additional measures include the Clinical and Patient Global Impression scales and the State-Trait Anxiety Inventory.
Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, stated, “AFFIRM-1 trial initiation marks a major achievement for Bionomics as we enter the Phase 3 clinical stage, made possible by our recent capital raise and our expert clinical development team that has a proven track record of executing high quality trials on time and within budget. The Phase 3 study expands on the findings of the Phase 2 PREVAIL trial and brings us closer to potentially transforming the treatment paradigm for the millions of individuals who lack safe and effective acute, as-needed treatment options to assist them in facing anxiety-inducing situations.”
Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics