MGC Pharmaceuticals has secured approval from Australia’s Therapeutic Goods Administration to start the Phase IIB clinical trial of its CogniCann medical cannabis treatment for dementia and Alzheimer’s patients. The company’s manufacturing facility in Ljubljana, Slovenia, has also secured a permit to extract and develop its own Phytocannabinoid active pharmaceutical ingredients.
ASX listed biotech MGC Pharmaceuticals has secured a key approval from Australia’s Therapeutic Goods Administration to commence the Phase IIB clinical trial of its “CogniCann” medical cannabis product for the treatment of dementia and Alzheimer’s patients.
With this approval, the company can now start the recruitment of patients for the 16 week trial at the University of Notre Dame in WA, which remains on track to start in the first half of this year.
The trial will be carried out on a total of 50 patients aged 65 and over to assess the effects of the treatment on the symptoms of mild dementia and Alzheimer’s and the improvement of patient’s quality of life.
CogniCann is MGC’s second “good manufacturing practice” or GMP certified, investigative medicinal cannabis product with a specific ratio of tetrahydrocannabinol and cannabidiol designed for the treatment of key dementia symptoms.
Separately, the company has reached another key milestone after its manufacturing facility in Ljubljana, Slovenia, became one of the first in the European Union to receive permission to extract and develop its own Phytocannabinoid active pharmaceutical ingredients, or “API”.
The green light from the Slovenian Ministry of Health gives MGC a leg up towards the full integration for production of its own bio-pharma products.
This includes developing new formulations with Phytocannabinoids coming from different genetics to gain different and new natural APIs.
It also allows the company to produce its own APIs in-house at a very low cost base for its own Phytomedicine production.
MGC is also the first Australian medical cannabis company to receive qualification from the European Medicines Agency for all its Phytomedicines.
This provides the company with a guide to the procedures to support research and development initiatives and the requirements to successfully obtain marketing authorisation.
It also allows MGC to apply for scientific advice, drug evaluation and registration of CannEpil, CogniCann and all other Phytomedicines currently under development.
CannEpil is a cannabis-derived drug that was developed to assist epilepsy sufferers control their neurological disorder, particularly where traditional drugs and medicines had no discernible impact on the condition.
In addition, the company can obtain fee reductions of up to 100% during the evaluation and registration process of priority medicines that target an unmet medical need.
MGC Managing Director Roby Zomer said: “We are extremely excited to see our European operations progressing so considerably, especially the expansion of our R&D capabilities. Research and innovation are the lifeblood of the pharmaceutical industry and we are working hard to not only build a growing company but bring effective treatments to patients.”