The asset, EMD-RX5, is Emyria’s first solid, oral dosage form of ultra-pure CBD. It targets psychological distress for which there is currently no over-the-counter cure.
Emyria Ltd (ASX:EMD) has begun dosing participants in a clinical trial comparing EMD-RX5, its proprietary ultra-pure CBD capsule, to the currently available Epidyolex.
Competitor Epidyolex is sold by Jazz Pharmaceuticals and is the only CBD drug registered with both the TGA and FDA.
“Our Phase 1 clinical trial, which has now begun, will directly compare the safety and bioavailability of EMD-RX5 to Epidyolex,” said Emyria’s Managing Director Dr. Michael Winlo.
“Our first ultra-pure cannabidiol formulation versus the only successfully registered and reimbursed CBD oil on the global market to date.”
Improved bioavailability of EMD-RX5
The biotech’s Phase 1 clinical trial will evaluate the safety and bioavailability of EMD-RX5 versus Epidyolex, the only pure CBD drug officially registered with the TGA and FDA.
In a recent animal pharmacokinetic study, EMD-RX5 demonstrated higher peak concentrations and improved bioavailability over a 24-hour period compared to the equivalent dose of Epidyolex.
EMD-RX5 is Emyria’s first ultra-pure CBD biopharmaceutical with the potential to treat multiple clinical indications.
For now, the Company is seeking registration of EMD-RX5 as a low-dose, over-the-counter CBD treatment for the symptoms of mental distress, which affects 15% of the adult population and for which there is currently no over-the-counter medication. counter treatment.
Next comes the phase 3 study
The Company has completed the design and planning for a pivotal Phase 3 study, expected to begin immediately after the Phase 1 study, and to be conducted at multiple independent clinical sites across Australia.
EMD-RX5 is the first of two unique 100% proprietary solid oral CBD dosage 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) — which includes outcome data from more than 6,000 patients treated by the company’s clinical services subsidiary — has guided the development of its growing portfolio of ultra-pure cannabinoid biopharmaceuticals.
The clinical services subsidiary, already operating across Australia, will help expedite recruitment by identifying eligible patients who will be referred to the independent sites for formal screening.
Second CBD asset in the works
Phase 1 clinical trials are also planned for EMD-RX7, Emyria’s second ultra-pure CBD dosage form, targeting prescription indications where higher levels of CBD exposure are required.
“The head-to-head comparison with the world’s leading provider of registered cannabinoid medicines – Epidyolex – is important to us as Emyria is fully committed to developing differentiated registered biopharmaceuticals in large global markets for important clinical indications,” said Winlo.
“Planning for the upcoming pivotal phase 3 clinical trials for EMD-RX5 has been completed and (the trial) is expected to begin immediately upon completion of this phase 1 trial.
“Additional Phase 1 trials are also planned for our other high-purity cannabinoid medicines, including EMD-RX7, which is targeting indications that require higher levels of CBD exposure.
“I look forward to providing further updates on our registry progress as well as our growing cannabinoid and MDMA analogue pipeline in the near future.”