Bionomics Candidate Offers Hope for 13 Million Americans Living with Post-Traumatic Stress
Clinical-stage biotechnology company, Bionomics Limited (Nasdaq: BNOX), is offering hope to the more than 13 million Americans living with post-traumatic stress disorder (PTSD), a debilitating psychiatric condition. The company has released the full dataset analysis from its Phase 2b ATTUNE trial of BNC210 in patients with PTSD, which showed that BNC210 demonstrated a statistically significant improvement in PTSD symptom severity, suggesting a potential advantage over approved medications.
Bionomics will use the study’s efficacy and safety observations to discuss the Phase 2b ATTUNE results with the FDA in the second quarter this year. The company expects to initiate a late-stage trial in the fourth quarter of 2024.
Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, commented, “The full results of the ATTUNE Phase 2b trial further strengthen the already compelling, topline results and position BNC210 as a potential highly differentiated treatment with rapid onset and durable efficacy that could improve outcomes for patients with PTSD.
“BNC210 is the only non-psychedelic experimental therapeutic with a novel mechanism of action that has generated evidence of a clinically meaningful improvement in PTSD total symptom severity, with a favorable effect size compared to approved treatments, and a favorable safety and tolerability profile.”
Highlights
Bionomics’ ATTUNE study is a Phase 2b double-blind, placebo-controlled, randomized trial of 900 mg BNC210 dosed twice daily as monotherapy treatment for PTSD.
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.
BNC210 is under development for the treatment of PTSD and Social Anxiety Disorder (SAD). It has been granted 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.
About Bionomics Limited
Bionomics (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
