Emyria and Cann Group have announced a collaboration to seek accelerated registration of a unique, low-dose, CBD-only capsule with the Therapeutic Goods Administration (TGA) for sale over the counter in pharmacies.
Under the agreement, Emyria’s EMD-003 drug-development program will use Cann’s proprietary Gelpell microsphere technology as the basis for seeking a Schedule 3 registration for treating unmet needs in mental health.
A recent internal analysis by Emyria revealed that more than 50% of its Emerald Clinics’ patients present with moderate to severe depression, anxiety and/or stress as measured by validated clinical assessments.
If successful, the collaboration will deliver a new, registered medicine to treat those patients.
A joint project committee will be formed to oversee the allocation of registration costs and the development of commercialisation agreements.
Cann Group recently acquired the rights to the Gelpell technology through its acquisition of the Satipharm Group, 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.
The collaboration capitalises on a number of important milestones that have already been met:
● Phase 1 trials 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 177 patients taking the Satipharm CBD capsule
● Emyria has prepared protocols for pivotal clinical trials for the target indications
Emyria’s drug development and clinical team will lead the registration program. Clinical trials are in the 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 Emerald Clinics.
Emyria managing director Dr. Michael Winlo said: “This partnership greatly accelerates Emyria’s EMD-003 drug-development program by combining [our] 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.
“We already have deep insights into how the Satipharm product performs clinically, having written over 400 Satipharm prescriptions to more than 170 patients.”
Cann Group CEO 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 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 [their] 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.”