- Bionomics (BNO) initiates a trial to evaluate a tablet for patients suffering post-traumatic stress disorder (PTSD)
- The Phase 2b study using BNC210 in tablet form is a randomised, placebo-controlled clinical trial
- Approximately 200 patients will be dosed twice daily to measure improvements in PTSD symptoms and changes in anxiety
- Top line results from the trial are expect in the first half of 2023
- Bionomics is trading in the grey at 20 cents per share at 3:00 pm AEST
The Phase 2b trial, known as the ATTUNE Study, will evaluate a tablet formulation of BNC210, a treatment used for relieving anxiety and stressor-related disorders.
The tablet received Fast Track designation by the US Food and Drug Administration (FDA) after the high unmet medical need for PTSD treatment was recognised.
The ATTUNE study is a randomised, double-blind, placebo-controlled clinical trial with a 12-week treatment period using an oral tablet formulation. The trial aims to compare BNC210 to a placebo, measuring improvements in PTSD symptoms.
In addition to this, the study will also look at changes in anxiety and depression symptoms, and social functioning in the study participants.
Around 200 patients will be dosed twice daily following data from previous trials, with testing conducted at around 25 clinical sites across the US.
Bionomics’ Executive Chairman Errol De Souza said PTSD affected up to 8 per cent of adults in their lifetime, with no newly approved pharmacotherapy seen on the market in almost two decades.
“Beyond PTSD, we will be leveraging the rapid absorption profile of the tablet formulation for an acute treatment in social anxiety disorder patients and look forward to providing details of the study design and timelines in the near future,” Dr De Souza said.
Top line results from the trial are expected in the first half of 2023.
Bionomics was trading in the grey at 20 cents per share at 3:00 pm AEST