Emyria Ltd (ASX:EMD) has signed up eight clinical sites across Australia to support the pivotal Phase 3 clinical trial of EMD-RX5, its first ultra-pure cannabinoid treatment.
The trial is now accessible to participants across Western Australia, Queensland, New South Wales, South Australia and the Australian Capital Territory. Emyria’s nationwide clinical service subsidiary, Emerald Clinics, will begin accepting patient expressions of interest for these sites from September 28.
Global market for psychological distress
Drug candidate EMD-RX5 has the potential to address multiple clinical indications, exhibiting the required purity necessary for Emyria to pursue registration opportunities across multiple major global markets.
The company expects results from the Phase 3 trial to support an initial registration of EMD-RX5 as a Schedule 3, over-the-counter treatment with Australia’s Therapeutic Goods Administration (TGA).
Though EMD-RX5 has the potential to target a range of indications, Emyria will start by seeking registration for symptoms of psychological distress.
The eight new qualified sites have successfully passed extensive feasibility and suitability screens with an independent monitor, joining previously activated sites following ethics approval in August.
Qualified sites are formally approved to participate in core trial activities such as patient recruitment, treatment dosing and clinical assessments.
Exceptional demand
Emyria managing director Dr Michael Winlo said: “We have had exceptional demand to participate in our Phase 3 program from clinical sites across Australia.
“We take this as a strong sign that there is high clinical interest in our unique Ultra-Pure CBD capsule and strong patient need for new treatment options for our target indication – the symptoms of psychological distress.
“Eight additional clinical trial sites are now poised to commence patient recruitment across Australia, with our trial drug EMD-RX5 being readied for distribution over the coming weeks.
“In parallel, we are advancing commercialisation discussions and look forward to providing more updates on the registration of EMD-RX5 in future announcements.”
The company has picked out a further four sites for qualification if the trial expands.
About EMD-RX5
EMD-RX5 was developed to overcome the limitations of commonly available cannabinoid medicines. It has been clinically demonstrated to have excellent safety, tolerability, bioavailability and low patient variability in a head-to-head comparison with the only registered CBD medicine in the world – Epidyolex.
The target indication, psychological distress, describes a set of mental and physical symptoms such as anxiety, stress, depression, sleep disturbance and gastrointestinal upset that, at any one time, can affect up to 15% of the adult population.
Psychological distress has a higher incidence rate in rural patients and patients with chronic disease.
The incidence of psychological distress is believed to be increasing, and yet there is currently no over-the-counter treatment for it.