Bionomics Limited Completes Last Patient Visit in PTSD Treatment Study
Bionomics Limited (Nasdaq: BNOX) has completed the last patient visit in its Phase 2 ATTUNE study of BNC210 as a treatment for post-traumatic stress disorder (PTSD). BNC210 is a non-sedating drug designed to reduce anxiety. The company’s share price rose more than 35% following the news.
Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, said, “We continue our strong momentum with our fast track designated BNC210, with a robust clinical and regulatory milestone-rich year in both SAD and PTSD, two highly prevalent neuropsychiatric disorders with significant unmet needs. I would like to thank study participants, their families, our clinical site investigators and their staff and our clinical team for their contributions towards achieving completion of the ATTUNE study.”
Topline results are anticipated by the end of September 2023.
The Phase 2b ATTUNE study (NCT04951076) is a double-blind, placebo-controlled, randomized study of twice daily BNC210 as monotherapy treatment for PTSD.
The primary endpoint is change in total symptom severity scores from baseline to week 12 compared to placebo. Secondary endpoints include improvements in measures on the PTSD-checklist (PCL-5), including anxiety, depression, sleep and disability.
Approximately 200 participants have been enrolled at 27 sites in the United States and 7 sites in the United Kingdom.
Bionomics (ASX:BNO, NASDAQ:BNOX) is 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. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of Social Anxiety Disorder (SAD) and chronic treatment of Post-Traumatic Stress Disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need. www.bionomics.com.au