Bionomics Limited, a clinical-stage biopharmaceutical company, is pleased to announce the successful completion of its randomized, double-blind, placebo-controlled, multi-center Phase 2b ATTUNE clinical trial of BNC210 for the treatment of Post-Traumatic Stress Disorder (PTSD).
Over 200 participants have been enrolled in the trial, and the Company expects to announce the topline results in the third quarter of 2023. This innovative treatment has the potential to provide hope to those suffering from PTSD and underscores Bionomics’ commitment to developing novel treatments for serious central nervous system disorders.
2023 is a momentous year for Bionomics, as the completion of enrollment in the Phase 2b ATTUNE trial paves the way for a timely topline readout. We are immensely grateful to trial participants, their families, and to our investigators and their staff for their unwavering commitment to our trial and to addressing the needs of patients with CNS diseases.
Moreover, we are bolstered by the promising results of the Phase 2 PREVAIL study in Social Anxiety Disorder (SAD) with BNC210. Our SAD and PTSD programs have the potential to revolutionize the treatment landscape for these highly prevalent neuropsychiatric disorders.
Attune, a Phase 2b double-blind, placebo-controlled study, is now recruiting participants to evaluate the effectiveness of BNC210 in treating PTSD. If you are between 18 and 75 years old and have been diagnosed with PTSD (as evidenced by a CAPS-5 total symptom severity score of ≥30 at screening and baseline, and a ≤25% decrease in CAPS-5 score from screening to baseline), you may be eligible to take part in the study.
Participants will receive either placebo or BNC210 twice daily as monotherapy treatment. The primary endpoint of the study is to measure the change in CAPS-5 total symptom severity scores from baseline to week 12 compared to placebo.
Secondary endpoints include assessments of PTSD-checklist, anxiety, depression, clinician global impression, patient global impression, sleep, and disability. Already, 200 participants have enrolled in the study across 27 sites in the United States and 7 sites in the United Kingdom. If you are interested in participating, please contact a local study site to learn more.
About Post Traumatic Stress Disorder
Do you ever feel like you just can’t get past a certain traumatic event that you experienced or witnessed? If so, you may be suffering from Post-Traumatic Stress Disorder (PTSD). People with PTSD experience intense and persistent thoughts and feelings associated with the traumatic event, often reliving it through flashbacks and nightmares.
They may feel isolated or detached from others, and negative reactions to everyday stimuli such as loud noises or an accidental touch may become increasingly common. To cope with their pain, those with PTSD may avoid situations or people that remind them of the event. If you’re struggling to move on from a traumatic experience, it’s important to seek help and support.
BNC210 is a revolutionary new drug under development that promises to help those suffering from SAD and PTSD. It works by modulating the α7 nicotinic acetylcholine receptor, and has been granted FDA Fast Track designation for its potential to treat PTSD, other trauma and stressor related disorders, and acute treatment of SAD and other anxiety related disorders. With BNC210, those struggling with these conditions may soon have a new hope for relief.