Data-backed drug development and care delivery company Emyria Limited (ASX: EMD) has engaged AltaSciences to deliver a range of proprietary, synthetic cannabinoid-based capsules utilising a unique drug delivery approach.
These capsules will become the foundation for Emyria’s cannabinoid drug development programs targeting registration with the TGA and FDA, leading with the EMD-003 over-the-counter (OTC) programme.
The new capsules are being developed to meet both TGA and FDA quality standards and are likely to be much more cost effective than the previous supply options considered and will allow Emyria to retain 100% ownership of all commercialisation rights and revenues.
By selecting synthetic CBD, Emyria has ensured that its drug development programs, and Australian-based clinical trials, can also support the pursuit of FDA registration following TGA registration. There is no pharmacological difference in vitro in the antiproliferative, anti-inflammatory, or permeability effects of purified botanical CBD versus pure synthetic CBD [1]. Further, the development benefits and cost savings that synthetic drug material provides are substantial. The synthetic platform under development is expected to support multiple drug registration programs with the TGA and FDA.
Emyria’s EMD-003is a Schedule 3, low-dose cannabidiol drug registration programme and will be the first to make use of the new pure synthetic dose form. EMD-003 is targeting the symptoms of psychological distress.
The programme is on track to deliver one of the first successfully registered, over-the-counter CBD medicines in Australia. Emyria has already completed much of the preliminary registration work:
We are excited to be contracting AltaSciences to deliver a range of novel synthetic CBD medicines for our drug registration programmes led by EMD-003,” Managing Director, Dr Michael Winlo, said.
“Emyria has been seeking a platform which can deliver a proprietary, cost effective and FDA-compliant cannabinoid medicine for some time. We have always been committed to pursuing registration opportunities with the FDA in the USA in parallel to our Australian programmes as the US is the world’s largest pharmaceutical market. The FDA is tightening rules on cannabinoid medicines and registration is required if reimbursement and product claims are targeted.
“The novel platform we are advancing with AltaSciences has several key benefits for Emyria. First, all of our GMP cannabinoid products will also meet FDA specifications for purity and quality. This means the clinical trials and investment required to obtain TGA registrations can also support our FDA registration plans. This brings our US registration plans forward significantly.
“Emyria will also have complete ownership over our Australian and US drug development programs, reducing our reliance on third-parties and allowing us to move rapidly towards TGA registration and sales in pharmacies where there is already a great deal of patient and commercial interest.
“Further, our pure API can be supplied to patients far more cost effectively. As patients will have to pay out-of-pocket for an over-the-counter CBD, it is essential to register a product that is effective, affordable and reliable to achieve large-scale uptake and sales. Currently, patients are required to spend more than $400 a month, out-of-pocket, which is not sustainable.
“For EMD-003, we believe our clinical data, drug development expertise and patent portfolio, when combined with a unique and low-cost dose form, will allow us to become one of the first successfully registered and affordable Schedule 3 cannabinoid medicines in Australia. We look forward to providing more updates to the market about our global registration plans in the coming weeks.”
