Once upon a time, stress ensured our survival. When faced with a dangerous situation our body responds instantly- heart rate increases, blood pressure climbs and muscles tighten as the body prepares to deal with the bear/ exam you’ve been presented with.
In the modern world we are faced with a disproportionately higher amount of exams and meetings than bears, yet our response hasn’t changed an awful lot.
Whilst stress can motivate us to get sh*t done, prolonged stress can seriously impact our physical and mental wellbeing.
Sometimes traumatic events can trigger a set of stress reactions that persist past the event itself. Sadly, 12% of Australians will experience Post Traumatic Stress Disorder (PTSD) in their lifetime.
With limited pharmacologic treatment options, global clinical stage biopharmaceutical company Bionomics Limited (ASX: BNO) has been granted Fast Track designation by the FDA to trial their drug for the treatment of PTSD and other trauma related disorders.
The lead drug candidate, BNC210, is designed to treat anxiety and stressor related disorders such as PTSD and address the serious unmet need.
The Company today announced the initiation of their phase 2b clinical trial with results expected in 1H 2023. The ATTUNE study will assess the efficacy of the tablet formulation BNC210 in patients with PTSD which has shown better absorption than the liquid suspension form. Dosage for the trial has been informed by previous studies of the drug.
The randomised, double-blind, placebo-controlled study will involve 12 weeks of treatment to compare the drug against placebo in lowering and improving PTSD symptom severity as measured by the Clinician Administered PTSD Scale.
Secondary objectives include: measurement of patient-reported symptoms of PTSD, changes in anxiety and depression symptoms and, global and social functioning in the study participants
Leading contract research organisation, Premier Research will manage the ATTUNE study which is to be conducted at 25 clinical sites in the US.
Executive Chairman Dr. Errol De Souza said: “PTSD affects up to 8% of adults in their lifetime and is a significant burden for patients suffering from the disorder with no newly approved pharmacotherapy in almost two decades beyond the two antidepressants sertraline and paroxetine. Data from our recent 7-day pharmacokinetic study in healthy volunteers demonstrated the new spray dry oral solid dose tablet formulation of BNC210 at the dosing regimen being used in the ATTUNE PTSD trial is well-tolerated and not only meets but exceeds the blood exposure predicted from the pharmacometric analysis as necessary for future trials. 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 for the study design and timelines in the near future.”