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Emyria announce positive animal study data received for Emyria's novel: ultra-pure CBD capsule


  • Emyria has received positive preliminary results from a pre-clinical head-to-head animal study comparison of Emyria’s proprietary, ultra-pure cannabidiol (CBD) formulation (EMD-003 capsule) to the only registered CBD product in Australia and the US (Epidyolex oil)

  • EMD-003 had a greater peak concentration and improved bioavailability compared to an equivalent dose of Epidyolex over a 24 hour period (see Figure 1)

  • EMD-003 is comprised of ultra-pure CBD and FDA-approved ingredients, simplifying future registration with major regulators like the Therapeutic Goods Administration (TGA) in Australia and the Food and Drug Administration (FDA) in the USA

  • Emyria is targeting a Schedule 3 registration with the TGA for EMD-003 in 2022

  • Pivotal clinical trials are due to commence Q1, 2022 starting with a Phase 1, healthy volunteer trial of EMD-003 which will also use Epidyolex as a comparator

Emyria Limited (ASX: EMD) (Emyria or the Company), data-backed drug development and care delivery company, is pleased to announce positive bioanalytical results of its proprietary, ultra-pure CBD formulation.

Emyria has been developing a proprietary CBD capsule with Altasciences. [1]

Emyria’s 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.”

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