Emyria Ltd (ASX:EMD) is set to commence a pivotal Phase 3 clinical trial of its Ultra-Pure Cannabidiol (CBD) candidate, EMD-RX5, for the treatment of psychological distress after receiving approval from the Human Research Ethics Committee (HREC).
The successful completion of the trial will support EMD-RX5’s registration with the Therapeutic Goods Administration (TGA) as a schedule 3, over-the-counter treatment (OTC) for the symptoms of psychological distress, for which there is currently no approved treatment.
Psychological distress describes a collection of symptoms that may comprise mild anxiety, stress, sleep disturbance and gastrointestinal upset. It affects up to 11% of all Australian adults with a higher prevalence in patients living with chronic disease, according to data from the Australian Institute of Health and Welfare in 2018.
Multi location trial
The Phase 3 trial will be a multi-centre, double-blind, randomised, placebo-controlled trial conducted under Australia’s Clinical Trials Notification (CTN) Scheme.
The first site to receive ethics approval is the Hatherley Medical Centre under the direction of principal investigator Dr Zachary Nathan. Other sites will be opened and managed across Australia by site management organisation, Clinitrials, with patient recruitment by Emyria’s clinical service subsidiary, Emerald Clinics, to commence soon.
The study’s primary endpoints are changes in validated psychological distress symptom scores, with secondary endpoints including validated measures of sleep, pain and other quality of life scores.
“Large opportunity”
Emyria managing director Dr. Michael Winlo said: “The commencement of our pivotal Phase 3 trial is a significant milestone for Emyria and for the many patients managing symptoms of psychological distress but without a registered over-the-counter treatment option.
“We believe a successfully registered OTC medicine in this category represents a large opportunity for Emyria to address a major unmet health need. We look forward to further evaluating EMD-RX5 for other indications and registration opportunities while we continue to expand our Ultra-Pure cannabinoid product portfolio, advance our MDMA-inspired drug discovery program and pursue commercialisation opportunities.”
Recent study
A recently completed Phase 1 pharmacokinetic crossover study of EMD-RX5 with Epidyolex®, the only TGA and FDA registered CBD medicine, revealed that EMD-RX5 delivers:
- excellent safety and tolerability with no gastrointestinal upset or adverse events of concern at test dose of 150mg;
- equivalent bioavailability and lower drug exposure variability; and
- higher CBD exposures three to eight hours after dosing, indicating EMD-RX5 provides more predictable drug exposure over time; suiting non-acute indications and supporting a preferred once-to-twice daily dosing regime.