“These animal study results suggest that Emyria has developed a new, high-performance, cost-effective CBD capsule that can meet strict product quality and purity registration requirements with both the TGA in Australia and the FDA in the United States. USA, “says MD.
Emyria Ltd (ASX: EMD) has taken a step closer to commercializing the patented treatment, EMD-003, an ultrapure cannabidiol capsule (CBD) formulation, with positive data from a preclinical animal study comparing it favorably with the only therapeutic. CBD treatment approved by the Merchandise Administration, Epidyolex oil.
Emyria has been developing EMD-003 as a low-dose, over-the-counter CBD drug with Altasciences, targeted at Registry 3 (Pharmacists Only) with the Administration of Therapeutic Products (TGA) in 2022.
The preclinical trial examined peak blood concentrations and bioavailability, with EMD-003 surpassing Epidyolex on both fronts for 24 hours. The study was conducted by Calvert Labs, an Altasciences company, using 8 canine subjects in an animal test.
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Epidyolex is the only plant-derived drug in the world, CBD-only, registered with both the US Federal Drug Administration (FDA) and the Australian TGA for the treatment of a rare type of epilepsy. Epidyolex is also the only CBD drug funded by the PBS (Pharmaceutical Benefits Scheme) in Australia.
High performance and cost effective CBD capsule
Emyria CEO Dr Michael Winlo said: “We are delighted to receive positive bioassay results for Emyria’s patented formulation of an ultra-pure CBD capsule.
“We were eager to evaluate the bioavailability of our formulation compared to the only CBD oil registered and successfully reimbursed on the market to date, Epidyolex.
“These animal study results suggest that Emyria has developed a new, high-performance, cost-effective CBD capsule that can meet strict product quality and purity registration requirements with both the TGA in Australia and the FDA in the United States. USA.
“We are now advancing our EMD-003 registration program, which is supported by real-world Emmyria-owned evidence, collected from 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 short-term registration programs.”
Towards registration and marketing
EMD-003 consists of ultra-pure CBD and FDA-approved ingredients that will simplify future Emyria registration efforts with major regulators such as the TGA in Australia and the FDA in the US.
Fundamental clinical trials for EMD-003 will begin in the first quarter of 2022, beginning with a Phase I trial in healthy volunteers to study EMD-003 compared to Epidyolex.
About Emyria
Emyria Ltd (ASX: EMD) is a data-driven clinical drug development and care delivery company focused on accelerating treatment development and improving patient care.
The company’s treatments are geared to unmet needs and focus on gaining approval from the world’s leading regulators.
Emyria’s drug development programs are based on the knowledge generated from a thorough analysis of Emyria’s data: in-depth and ethical clinical evidence that is collected with patients from Emmyria’s independent clinical services.
Emyria Data provides an in-depth look at treatment and is therefore a unique source of intellectual property, strategically designed drug development, and personalized care programs.
