Emyria Ltd’s ultra-pure CBD capsule outperforms TGA-approved CBD remedy in pre-clinical animal trial

“These results from animal studies suggest that Emyria has developed a novel, high-performance and affordable CBD capsule that can meet stringent registration requirements for product quality and purity with both the TGA in Australia and the FDA in the US,” says MD.

Emyria Ltd (ASX: EMD) has taken a step closer to commercializing its proprietary treatment EMD-003, an ultra-pure cannabidiol (CBD) capsule formulation, with positive data from a preclinical animal study comparing it positively to the only therapeutics from Merchandise Management Approved CBD treatment, Epidyolex oil.

With Altasciences, Emyria developed EMD-003 as a low-dose, over-the-counter CBD drug and is targeting Schedule 3 (pharmacist only) registration with the Therapeutic Goods Administration (TGA) in 2022.

The preclinical study looked at peak blood levels and bioavailability, with EMD-003 outperforming Epidyolex on both fronts over 24 hours. The study was conducted by Calvert Labs, an Altasciences company, on 8 canine subjects in an animal experiment.

Epidyolex is the world’s only plant-derived, pure CBD drug registered with both the U.S. Federal Drug Administration (FDA) and the Australian TGA for the treatment of a rare form of epilepsy. Epidyolex is also the only CBD drug subsidized by the Australian Pharmaceutical Benefits Scheme (PBS).

Powerful, affordable CBD capsule

Dr. Michael Winlo, Managing Director of Emyria, said, “We are very excited about the positive bioassay results for Emyria’s proprietary formulation of a high purity CBD capsule.

“We endeavored to evaluate the bioavailability of our formulation against the only successfully registered and reimbursed CBD oil on the market to date, Epidyolex.

“These results from animal studies suggest that Emyria has developed a novel, high-performance, and affordable CBD capsule that can meet stringent registration requirements for product quality and purity with both the TGA in Australia and the FDA in the US.

“We are now advancing our EMD-003 registration program, which is based on Emyria’s proprietary practice evidence gathered on thousands of patients.

“These results also give us the confidence to initiate additional cannabinoid registration programs with the TGA and FDA based on the underlying formulation approach, and we look forward to providing further updates on EMD-003 and other registration programs soon.”

For registration and commercialization

EMD-003 is made from high-purity CBD and FDA-cleared ingredients that will facilitate future Emyria registration efforts with key regulatory agencies such as the TGA in Australia and the FDA in the US.

Key clinical studies for EMD-003 are scheduled to begin in the first quarter of 2022, beginning with a Phase I trial in healthy volunteers to evaluate EMD-003 versus Epidyolex.

About Emyria

Emyria Ltd (ASX: EMD) is a data-driven clinical drug development and supply company focused on accelerating treatment development and improving patient care.

The company’s treatments target unmet needs and focus on gaining approval from key global regulatory agencies.

Emyria’s drug development programs are based on insights gained from extensive analysis of Emyria data – solid clinical evidence from ethical sources, compiled with patients in Emyria’s independent clinical services.

Emyria Data offers deep treatment insights, making it a source of unique intellectual property, strategically designed drug development and personalized care programs.