Emyria Limited (ASX: EMD) and Cann Group Limited (ASX: CAN) are pleased to announce a collaboration agreement to seek 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, as the basis for seeking a Schedule 3 registration for treating unmet needs in mental health.
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.”
Cann Group CEO, Peter Crock, said:
“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.”