Emyria Ltd (ASX:EMD) has dosed its first patients in the pivotal Phase 3 clinical trial of lead drug candidate EMD-RX5.
This marks an important milestone in the development of EMD-RX5 as the first potential over-the-counter (OTC) treatment for the symptoms of psychological distress.
The drug candidate is a proprietary, solid-capsule formulation of Ultra-Pure CBD targeting registration as one of the first OTC CBD medications registered with Australia’s Therapeutic Goods Administration (TGA).
Safety and efficacy
The Phase 3 trial, which is being conducted nationwide across nine trial sites, is designed to evaluate the safety and efficacy of EMD-RX5 in patients with symptoms of psychological distress such as mild anxiety and stress.
The trial is expected to enrol and dose 300 patients during the course of the first half of 2023 and, pending clinically significant results, will support a submission to the TGA.
More than 200 patients have now been pre-screened, with the rate of patient dosing expected to increase due to significant early engagement and ongoing support from partner Emerald Clinics.
OTC advantages
There are multiple comparative advantages to Emyria’s over-the-counter registration program:
- EMD-RX5 is a proprietary, solid capsule of Ultra-Pure CBD without THC or impurities;
- EMD-RX5 has demonstrated high bioavailability in Phase 1 trials;
- Emyria is testing up to 150mg CBD per day - the maximum allowable dose for OTC; and
- Emyria is the only company targeting the symptoms of psychological distress – a condition affecting 15% of the Australian adult population with no OTC treatment currently available.
Emyria managing director Dr Michael Winlo said: “An accessible, convenient and effective over-the-counter treatment for psychological distress could have a significant impact on the quality of life and health outcomes for patients, especially those with chronic disease.
“We believe EMD-RX5 represents a significant commercial opportunity as it has been uniquely formulated to meet the registration requirements of multiple global markets.
“The need for mental health treatments is large and growing, and an over-the-counter option could support a large segment of the population alongside prescription medication and non-drug therapy.”