Lead Programs
Social Anxiety Disorder (SAD)
Social Anxiety Disorder is a serious anxiety disorder characterized by the persistent, intense fear of social or performance-related situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. SAD can also be evident in limited settings such as a fear of speaking in formal or informal situations or induced by social interactions across any variety of situations.
For more information on Social Anxiety Disorder, please click on the links below:
- NIMH Mental Health Information SAD Site
- Anxiety and Depression Association of America
- Mayo Clinic
- Cleveland Clinic
In December 2022, we announced the results of the Phase 2 PREVAIL trial, which was a double-blind, placebo-controlled trial in SAD. While PREVAIL narrowly missed its primary endpoint, topline data readout revealed encouraging results in the prespecified endpoints and nominally significant results in post-hoc analyses.
In July 2024, we announced the initiation of patient screening for the Phase 3 AFFIRM-1 trial evaluating the safety and efficacy of BNC210 for the acute, as-needed treatment of social anxiety disorder (SAD). AFFIRM-1 targets enrollment of 330 adult patients with SAD at clinical sites in the United States (U.S.).
BNC210 has exhibited anti-panic properties by reducing the number and intensity of panic symptoms in a human model Phase 1b study of Panic Disorder. In a Phase 2 study in patients with Generalized Anxiety Disorder (GAD), BNC210 has demonstrated anti-anxiety activity in a behavioural model of threat avoidance and on anxiety scale scores (STAI). Using functional magnetic resonance imaging (fMRI), BNC210 was shown to reduce hyperactivity in the amygdala of the brain, a region where increased activity is associated with anxiety.
For more information on our anxiety disorders clinical trials, please visit clinicaltrials.gov.
If you are interested in participating in AFFIRM-1 please visit the trial website.
Post-Traumatic Stress Disorder (PTSD)
Post-Traumatic Stress Disorder is a serious, chronic condition triggered by a broad range of severe trauma types such as traumatic experiences in combat experienced by military personnel and other experiences such as childhood trauma and rape. Trauma exposure can trigger a distinctive pattern of persistent, disabling behavioral and physiological symptoms, which include intrusive memories and nightmares of the trauma, severe anxiety, irritability, hypervigilance, depression, difficulty sleeping, poor concentration, and emotional withdrawal.
For more information on post-traumatic stress disorder, please click on the links below:
- NIMH Mental Health Information PTSD Site
- APA
- Anxiety and Depression Association of America
- Mayo Clinic
- Cleveland Clinic
In September 2023, we announced the positive results of the Phase 2b ATTUNE trial, which was a double-blind, placebo-controlled trial conducted in a total of 34 sites in the United States and the United Kingdom. The ATTUNE trial was successful in demonstrating a statistically significant reduction in change from baseline CAPS-5 total symptom severity scores, compared to placebo, with full onset of effect observed as early as Week 4 , the earliest timepoint measured. This robust effect was sustained through Week 8 and Week 12 (effect size = 0.40). The early onset of effect with BNC210 has the potential to provide rapid and timely relief for PTSD patients.
For more information on our PTSD clinical trials, please visit clinicaltrials.gov.