Bionomics completes enrollment in the phase 2b ATTUNE trial of BNC210 in patients with post-traumatic stress disorder

Bionomics Limited, a clinical-stage biopharmaceutical company, announced that it has reached its target enrollment of approximately 200 participants in its multi-center phase 2b ATTUNE clinical trial evaluating BNC210 in Post-Traumatic Stress Disorder (PTSD). The first financial results are expected in the third quarter of 2023. "2023 is shaping up to be a pivotal and milestone-filled year for Bionomics." Enrollment in the Phase 2b ATTUNE study has been completed, paving the road for a fast topline readout and highlighting our mid- and late-stage clinical development capabilities.

"We would like to express our continued appreciation to trial participants, their families, and our investigators and staff for their shared commitment to our trial and addressing the needs of patients with CNS diseases," said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. "Our momentum is growing as a result of encouraging results with BNC210 in our phase 2 PREVAIL study in Social Anxiety Disorder (SAD)." Our SAD and PTSD courses, when combined, have the potential to change the treatment paradigm for two highly prevalent neuropsychiatric illnesses."

ATTUNE is a phase 2b double-blind, placebo-controlled, randomised trial of 900 mg BNC210 administered twice daily as monotherapy for PTSD. Participants in the study are randomly assigned to either a placebo or BNC210. Being 18-75 years old, having a current PTSD diagnosis with a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score of = 30 at screening and baseline, and having a = 25% drop in CAPS-5 score from screening to baseline are key inclusion criteria. The primary endpoint is change in CAPS-5 total symptom severity scores from baseline to week 12 compared to placebo.

Secondary endpoints include change from baseline to week 12 compared to placebo on the PTSD-checklist (PCL-5), anxiety (Hamilton Anxiety Rating Scale, HAM-A), depression (Montgomery-Asberg Depression Rating Scale, MADRS), Clinician Global Impression (CGI), Patient Global Impression (PGI), sleep (Insomnia Severity Index, ISI) and disability (Sheehan Disability Scale, SDS). Approximately 200 participants have been enrolled at 27 sites in the United States and 7 sites in the United Kingdom. Post-Traumatic Stress Disorder (PTSD) is a psychiatric condition that may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. People with PTSD have intense, disturbing thoughts and feelings related to their experience that persist long after the traumatic event has ended. They may relive the event through flashbacks or nightmares, may feel sadness, fear or anger and may experience a sense of detachment or estrangement from others.

As a result of these feelings, people with PTSD may avoid situations or people that remind them of the traumatic event, and they may have strong negative reactions to commonplace stimuli such as loud noises or an accidental touch. BNC210 is a negative allosteric modulator of the a7 nicotinic acetylcholine receptor under development for the treatment of SAD and PTSD. BNC210 has been given FDA Fast Track designation for treatment of PTSD and other trauma and stressor related disorders and for acute treatment of SAD and other anxiety related disorders. Bionomics is a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious CNS disorders with high unmet medical need.