The asset, EMD-RX5, is Emyria’s first solid, oral dose form of ultra-pure CBD. It will target psychological distress, for which there is currently no over-the-counter remedy.
Emyria Ltd (ASX:EMD) has started dosing participants in a clinical trial comparing EMD-RX5, its proprietary capsule of ultra-pure CBD, with the currently available Epidyolex.
Competitor Epidyolex is sold by Jazz Pharmaceuticals and is the only CBD medicine registered with both the TGA and FDA.
“Our Phase 1 clinical trial, now commenced, will directly compare the safety and bioavailability of EMD-RX5 to Epidyolex,” Emyria’s managing director Dr Michael Winlo said.
“Our first ultra-pure cannabidiol formulation versus the only successfully registered and reimbursed CBD oil in the global market to date.”
Improved bioavailability of EMD-RX5
The biotech’s Phase 1 clinical trial will assess the safety and bioavailability of EMD-RX5 against Epidyolex, which is the sole CBD-only medicine formally registered with the TGA and the FDA.
In a recent pharmacokinetic animal study, EMD-RX5 showed greater peak concentration and improved bioavailability compared to the equivalent dose of Epidyolex over a 24-hour period.
EMD-RX5 is Emyria’s first ultra-pure CBD biopharmaceutical with the potential to address multiple clinical indications.
For now, the company is targeting EMD-RX5’s registration as a low-dose, over-the-counter CBD treatment for the symptoms of psychological distress, which affects 15% of the adult population and for which there is currently no over-the-counter treatment.
Phase 3 study up next
The company has wrapped up the design and planning for a pivotal Phase 3 trial, which is expected to start immediately on the heels of the Phase 1 study and to run across multiple independent clinical sites across Australia.
EMD-RX5 is the first of two unique, 100%-owned, solid oral CBD dose forms developed by Emyria using ultra-pure, nature-identical CBD with the potential to support a range of TGA and FDA indications.
Emyria’s proprietary Real-World Data (RWD) – covering outcome data on more than 6,000 patients receiving care at the company’s clinical service subsidiary – has guided the development of its growing portfolio of ultra-pure cannabinoid biopharmaceuticals.
The clinical service subsidiary, already operating across Australia, will assist in accelerating recruitment by identifying suitable patients to be referred for formal screening at the independent sites.
Second CBD asset in the works
Phase 1 clinical trials are also in planning for EMD-RX7, Emyria’s second, ultra-pure CBD dose form targeting prescription indications where higher CBD exposures are required.
“The head-to-head comparison with the global leader in registered cannabinoid medicines – Epidyolex – is important to us, as Emyria is fully committed to developing differentiated registered biopharmaceuticals in large global markets for major clinical indications,” Winlo said.
“Planning for the upcoming pivotal Phase 3 clinical trials for EMD-RX5 has been completed, and (the trial) is expected to commence immediately after the completion of this Phase 1 study.
“Additional Phase 1 trials are also planned for our other ultra-pure cannabinoid medicines including EMD-RX7, which is 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.”
