Emyria Limited (ASX: EMD) and Cann Group Limited (ASX: CAN) have reached a collaboration agreement to seek accelerated registration of a unique, low-dose, CBD-only capsule with Australia’s Therapeutic Goods Administration (TGA).
Successful registration as a Schedule 3 medicine would result in an over-the-counter, pharmacist-only CBD medicine.
Under the agreement, Emyria’s EMD-003 drug development program will use Cann Group’s proprietary Gelpell microsphere technology, as the basis for seeking 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.
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.
Emyria’s experienced drug development and clinical team will lead the registration programme.
Emyria’s Managing Director, Dr.Michael Winlo, said 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.
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,” Dr Winlo said.
“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.”
EMD-003 is targeting psychological distress and the symptoms of anxiety, depression and stress for certain patient populations.
Mental health is a rising global health challenge, particularly in the last 12 months. In the 2017-2018 National Health survey, mental health topped the list of chronic health conditions in Australia affecting 4.8 million people, or 20.1% of all Australians. In any one year over two million Australians suffer from anxiety alone. Psychological distress, in particular, has been increasing in incidence.
A recent internal analysis had revealed that more than 50% of Emerald Clinics’ patients present with moderate to severe depression, anxiety and / or stress as measured by validated clinical assessments.
The collaboration, if successful, will deliver a new, registered medicine for the treatment of psychological distress and symptoms of depression, anxiety and stress.