Emyria Ltd (ASX:EMD) and Cann Group Limited (ASX:CAN) (OTCMKTS:CNGGF) (FRA:CVJ) have entered into a collaboration agreement to seek the accelerated registration of a unique, low-dose, CBD-only capsule with Australia’s Therapeutic Goods Administration (TGA).
Under the agreement, Emyria’s EMD-003 drug development program will use Cann Group’s proprietary Gelpell microsphere technology to seek a Schedule 3 registration for treating unmet needs in mental health.
A joint project committee will be formed to oversee the allocation of registration costs and the development of commercialisation agreements.
Saves "significant time and money"
Emyria managing director Dr Michael Winlo said: “This partnership greatly accelerates Emyria’s EMD-003 drug development program by combining Emyria’s unique clinical data and drug development expertise with Cann Group’s best-in-class CBD delivery technology.
“Satipharm CBD has already completed robust stability testing as well as Phase 1 clinical trials as required by the TGA.
“This allows us to move straight to pivotal clinical outcomes trials saving significant time and money.
“An experienced regulatory consultant has already been engaged to manage the TGA submission.
“Further, at Emyria, we already have deep insights into how the Satipharm product performs clinically, having written over 400 Satipharm prescriptions to more than 170 patients.
“This de-risks the pivotal clinical outcomes trials required as an important first step towards registration with the TGA.”
Successful registration with the TGA opens the path to registration opportunities overseas.
Australia’s largest production facility
Cann Group chief executive officer Peter Crock added: “Cann Group is pleased to partner with Emyria to accelerate the registration of a Schedule 3 medicine.
“We anticipate there will be a large patient demand for a TGA-registered CBD medicine that is convenient to patients and demonstrates the highest standards of quality, safety and efficacy.
“We believe our microsphere technology - with improved bioavailability – fits well with Emyria’s drug development programs, which have the potential to accelerate registration with the TGA due to Emyria’s extensive real-world data, national clinical site network and previous drug development experience.
“We are also working to bring the Gelpell pharmaceutical GMP manufacturing line to Cann’s Mildura production facility which, when commissioned at the end of this calendar year, will become the largest cannabinoid medicine production facility in Australia.”
The collaboration deal
Successful registration as a Schedule 3 medicine would result in an over-the-counter, pharmacist-only CBD medicine for the treatment of psychological distress and symptoms of depression, anxiety and stress.
The collaboration capitalises on a number of important milestones that have already been met:
- Phase 1 trials already completed for 10mg and 100mg doses of the Satipharm capsule;
- Satipharm CBD has been shown to have 3.5 times greater bioavailability compared to oil preparations (at 100mg);
- Long-term stability testing undertaken (and continuing);
- Emyria already has real-world data on more than 170 patients taking the Satipharm CBD capsule; and
- Emyria has prepared protocols for pivotal clinical trials for target indication Emyria’s experienced drug development and clinical team will lead the registration program.
Pivotal clinical trials are in advanced stages of planning and are being guided by insights from Emyria Data, which includes robust safety, efficacy and patient preference data for more than 3,500 patients treated at Emyria’s Emerald Clinics.
Gelpell technology
Cann Group’s microsphere formulation embeds CBD in seamless gelatine microspheres (tiny beads), which have a dimension of 2 mm or less and are packed in hard gastro-resistant capsules.
The active ingredients – cannabinoids - are bound and protected by a three-dimensional natural gelatine matrix in each bead.
These gelatine beads protect the CBD contained in them from heat, light and oxygen, exhibiting improved stability and bioavailability of cannabinoids compared to other formulations.
In a final dose form, these beads are placed in gastro-resistant capsules which protect the beads from acid in the stomach.
When swallowed, the beads disperse throughout the intestine, where they are absorbed by the body into both the bloodstream and the lymphatic system, minimising the impact of the first-pass metabolism in the liver and contributing to improved bioavailability.
Cann Group recently acquired the rights to the technology via the purchase of the Satipharm Group of companies, which has commercialised a CBD product utilising the technology.
Cann Group plans to incorporate manufacturing of the microsphere formulation in its new production facility currently under construction near Mildura.