Bionomics Announces Positive Topline Results from the Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD)
ATTUNE trial met its primary endpoint showing BNC210 treatment led to a statistically significant reduction in total PTSD symptom severity at 12 weeks.
Statistically significant secondary endpoints showed improvements in depressive symptoms and sleep.
BNC210 was well-tolerated with a safety profile supporting chronic administration.
Company plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the registrational path for BNC210 in PTSD.
Webcast and conference call will be held today at 8:00 AM EST (10:00 PM AEST).
Please click on the link to register: https://lifescievents.com/event/bnox/
ADELAIDE, Australia, and CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced positive topline results from its Phase 2b ATTUNE trial of BNC210 for the treatment of PTSD, as described more fully below.
ATTUNE is a double-blind, placebo-controlled Phase 2b trial conducted in a total of 34 sites in the United States and the United Kingdom, with 212 enrolled patients, randomized 1:1 to receive either twice daily 900 mg BNC210 as a monotherapy (n=106) or placebo (n=106) for 12 weeks. The trial met its primary endpoint of change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score from baseline to Week 12 (p=0.048). A statistically significant change in CAPS-5 score was also observed at Week 4 (p=0.015) and at Week 8 (p=0.014).
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Treatment with BNC210 also showed statistically significant improvement both in clinician-administered and patient self-reporting in two of the secondary endpoints of the trial. Specifically, BNC210 led to significant improvements at Week 12 in depressive symptoms (p=0.040) and sleep (p=0.041) as measured by Montgomery-Åsberg Depression Rating Scale (MADRS) and Insomnia Severity Index (ISI), respectively. BNC210 also showed signals and trends across visits in the other secondary endpoints including the clinician and patient global impression - symptom severity (CGI-S, PGI-S) and the Sheehan Disability Scale (SDS).
“We are excited about the results of the ATTUNE trial that delivered a positive dataset with treatment effects considerably higher than currently approved therapies. We believe these results will enable FDA discussions for the registrational path of BNC210 in PTSD, which in an indication with high unmet need”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “I am thankful to the patients, their families, and the clinical teams who participated and contributed to this study. These results, together with the results from earlier this year in social anxiety disorder, and the recently completed Phase 3-enabling End-of-Phase 2 meeting with the FDA on social anxiety disorder, positions BNC210 as a compelling late-stage experimental therapeutic for multiple prevalent neuropsychiatric diseases with high unmet need.”
Treatment with 900 mg twice daily BNC210 had a favorable safety and tolerability profile. The most common (>5% of subjects in each group) reported adverse events, including headache, nausea, and fatigue, which were consistent with previous studies with BNC210. A hepatic enzyme increase was observed in 14 (13.3%) patients treated with BNC210 vs 2 (0.19%) in the placebo group; the abnormal results were not associated with hepatic injury and in most cases were resolved without drug discontinuation.
“There is great unmet medical need for safe and effective treatments for the large population of patients suffering with PTSD worldwide. Despite the clinical heterogeneity of PTSD, the results of ATTUNE demonstrated broad benefits with BNC210 across a number of symptoms. This a promising step forward for patients with PTSD, where the majority do not achieve clinical remission with current therapies and there have been no newly approved therapies in the past 20 years.” commented Murray B. Stein M.D., M.P.H., Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and Staff Psychiatrist at the Veteran Affairs San Diego Healthcare System, and a consultant to Bionomics.
Additionally, the Company recently held what it believes was a successful, Phase 3-enabling End-of-Phase 2 meeting with the FDA for the advancement of BNC210 for the acute treatment of social anxiety disorder into registrational studies and is awaiting receipt of the formal meeting minutes.
The company will discuss the topline ATTUNE study results on the webcast today at 8:00am EST and is planning to advance BNC210 for the treatment of PTSD into registrational studies.
About ATTUNE
ATTUNE is a Phase 2b double-blind, placebo-controlled, randomized study of 900 mg BNC210 given twice daily as monotherapy treatment for PTSD. Study participants were randomized 1:1 to receive either placebo or BNC210. Key inclusion criteria include being 18-75 years of age, 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 ≤ 25% decrease in CAPS-5 score from screening to baseline. 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). 212 participants have been enrolled at 27 sites in the United States and 7 sites in the United Kingdom. For more information, see ClinicalTrials.gov Identifier: NCT04951076.
About Post Traumatic Stress Disorder
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.
About BNC210
BNC210 is a negative allosteric modulator of the a7 nicotinic acetylcholine receptor under development for the treatment of Social Anxiety Disorder (SAD) and PTSD. BNC210 has been given the 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. It should be noted that positive results in or from prior, current, or later clinical trials, studies and pre-clinical development may not provide positive data and/or similar results moving forward, as they are not a predictor or indicative of future results, success or regulatory approval.
FOR FURTHER INFORMATION PLEASE CONTACT:
General
Rajeev Chandra
Company Secretary
CoSec@bionomics.com.au Investor Relations
Kevin Gardner
kgardner@lifesciadvisors.com
Investor Relations
Chris Calabrese
ccalabrese@lifesciadvisors.com
Business Development
Matthew Brennan, MBA
Sr. Director, Business Development
mbrennan@bionomics.com.au
Business Development
Francisco M. Bejar
Strategic Advisor
fbejar@bionomics.com.au
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