Emyria Ltd (ASX:EMD) has taken a step closer to commercialisation of proprietary treatment, EMD-003, an ultra-pure cannabidiol (CBD) capsule formulation, with positive data from a pre-clinical animal study comparing it favourably to the only Therapeutics Goods Administration-approved CBD treatment, Epidyolex oil.
Emyria has been developing EMD-003 as a low-dose, over-the-counter CBD medicine with Altasciences, targeting schedule 3 (pharmacists only) registration with the Therapeutic Goods Administration (TGA) in 2022.
The pre-clinical trial examined peak blood concentrations and bioavailability, with EMD-003 outperforming Epidyolex on both fronts over 24 hours. The study was performed by Calvert Labs, an Altasciences company, using 8 canine subjects in a cross-animal trial.
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Epidyolex is the world’s only plant-derived, CBD-only medicine registered with both the US Federal Drugs Administration (FDA) and Australian TGA for the treatment of a rare type of epilepsy. Epidyolex is also the only CBD medicine subsidised by Australia's Pharmaceutical Benefits Scheme (PBS).
High performing, cost-effective CBD capsule
Emyria managing director Dr Michael Winlo said: “We’re delighted to receive positive bioanalysis results for Emyria’s proprietary formulation of an ultra-pure CBD capsule.
“We were eager to evaluate the bioavailability of our formulation compared to the only successfully registered and reimbursed CBD oil in the market to date, Epidyolex.
“These animal study results suggest Emyria has developed a novel, high performing and cost-effective CBD capsule that can meet the strict registration requirements for product quality and purity with both the TGA in Australia and the FDA in the USA.
“We are now advancing our EMD-003 registration program, which is supported by Emyria’s proprietary real-world evidence, collected with thousands of patients.
“These results also give us the confidence to launch additional cannabinoid registration programs with the TGA and FDA based on the underlying formulation approach, and we look forward to providing more updates on EMD-003 and additional registration programs in the near-term.”
Toward registration and commercialisation
EMD-003 is comprised of ultra-pure CBD and FDA-approved ingredients which will simplify Emyria’s future registration efforts with major regulators like the TGA in Australia and the FDA in the US.
Pivotal clinical trials for EMD-003 are due to begin in the first quarter of 2022, starting with a Phase I trial in healthy volunteers to study EMD-003 in comparison with Epidyolex.
About Emyria
Emyria Ltd (ASX:EMD) is a data-backed clinical drug development and care delivery company focused on accelerating treatment development and improving patient care.
The company’s treatments target unmet needs and are focused on obtaining approval from major global regulators.
Emyria’s drug development programs are informed by insights generated from extensive analysis of Emyria Data - deep, ethically sourced clinical evidence that is gathered with patients across Emyria’s independent clinical services.
Emyria Data provides deep treatment insights and is, therefore, a source of unique IP, strategically designed drug development and personalised care programs.
