Emyria Ltd (ASX:EMD) is expected to complete dosing today for a phase one trial of its ultra-pure cannabidiol (CBD) capsule, EMD-RX5.
The phase one clinical trial is assessing the safety, tolerability and bioavailability of EMD-RX5 compared to Epidyolex — the only CBD-only medicine registered with the Therapeutic Goods Administration (TGA) and the Food and Drug Administration (FDA) — and will support Emyria’s registration submission to the TGA.
EMD-RX5 is initially targeting registration as an over-the-counter (Schedule 3) treatment for symptoms of psychological distress, which affect 15% of the adult population and for which there is currently no over-the-counter treatment.
Emyria’s EMD-RX5 capsules were uniquely developed to:
- Meet FDA requirements for ingredient purity by using ultrapure CBD;
- Improve the bioavailability of CBD; and
- Create a palatable dose form for patients.
As a result, Emyria believes EMD-RX5 has the potential to address multiple clinical indications as a registered medicine where low doses of CBD appear to be effective.
Advancing towards registration
Twelve patients are set to receive their EMD-RX5 dose at CMAX in Adelaide today.
Speaking to the dosing milestone, Emyria managing director Dr Michael Winlo said: “Now dosing of EMD-RX5 has completed, we can commence the data analysis to compare the safety, tolerability and bioavailability of EMD-RX5 to the only sole registered and reimbursed CBD oil in the global market to date, Epidyolex, and move directly to our pivotal phase three clinical trial with partner Clinitrials.
“Our proprietary Real World Data, gathered with thousands of patients, is helping guide each of our drug development and registration activities which also includes EMD-RX7 targeting indications requiring higher CBD exposures.
“I look forward to providing further updates on our registration progress as well as our growing cannabinoid and MDMA analogue pipeline in the near-term.”
What’s next?
A pivotal phase three trial to support EMD-RX5’s registration has been planned. It’s expected to commence once Emyria closes the books on the phase one study.
Yesterday, the healthcare stock announced that leading contract research organisation and site management organisation Clinitrials has been appointed to manage the phase three trial across five to six sites in Australia.
Emyria’s wholly-owned clinical service subsidiary, already operating across Australia, is expected to further accelerate recruitment by helping identify suitable patients, who will then be referred for formal screening at independent sites managed by Clinitrials.
In addition, Emyria has developed a second, ultra-pure CBD medicine with potentially higher bioavailability, EMD-RX7, which is now also progressing towards a clinical trial. Further cannabinoid-based medical treatments are also in development.
More broadly, Emyria’s deepening drug development pipeline also includes new chemical entity development with MDMA-analogues.