Bionomics Reports Positive Topline Data in PTSD Study, Shares Soar 249%

Bionomics Limited’s (Nasdaq: BNOX) Phase 2b study evaluating BNC210 in post-traumatic stress disorder (PTSD) has garnered positive topline results, sending the company’s share price soaring by 249% in intraday trading on Thursday.

PTSD affects around 5% of all Americans and is characterized by  intense, disturbing thoughts, sadness, fear, or anger following a traumatic event.

Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, said, “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.”

Bionomics recently held a 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.

Highlights

Bionomics’ ATTUNE study is a double-blind, placebo-controlled Phase 2b trial conducted across 34 sites in the US and the UK, with 212 enrolled patients.

The trial met its primary endpoint and showed significant improvements in depressive symptoms and insomnia severity.

Treatment with 900 mg of BNC210 twice daily had a favorable safety and tolerability profile.

BNC210 has been granted FDA Fast Track designation for the treatment of PTSD and other trauma and stress related disorders and for acute treatment of SAD and other anxiety related disorders.

There is great unmet medical need for safe and effective treatments for the large population of patients suffering with PTSD worldwide. There have been no newly approved therapies in the past 20 years.

About Bionomics

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