MGC Pharmaceuticals | 22 October 2018
We assume that this 10% of patients with severe refractory epilepsy represent the main target
market for CannEpil. Applying this 10% factor to the prevalence of 6.4 patients with active epilepsy
per 1,000 head of population, we estimate the addressable patient population with severe,
treatment-resistant epilepsy to be ~69,000 young people aged less than 20 years and 260,000
adults aged over 20 in Europe, 3,900 young people and 11,600 adults in Australia, and 56,000
young people in the US.
CogniCann for dementia: A second pharmaceutical
MGC has announced plans to conduct a Phase II clinical trial of CogniCann in patients with mild
dementia and Alzheimer’s disease (AD). CogniCann is MGC’s GMP-certified medical cannabis
pharmaceutical product, which has been specifically formulated for the treatment of key dementia
symptoms and improving specific cognitive functions. Each 10m bottle of CogniCann contains
250mg THC and 170mg CBD. The trial leverages IP secured through the company’s Medical
Advisory Board, led by Professor Uri Kramer, which is based on experience gained through the use
of medicinal cannabis products in Israel.
Ethics approval has been received to conduct the study in partnership with the Institute for Health
Research at the University of Notre Dame in Western Australia. The trial, which will recruit a total of
50 subjects aged 65 years and older, is expected to commence in early 2019, subject to TGA
approval. The 16-week trial will use a randomised, double blind, crossover, placebo-control design
to evaluate behavioural changes, quality of life, level of discomfort and pain in dementia patients
living in residential aged care facilities (Exhibit 3).
CogniCann’s impact on dementia symptoms will be assessed by validated questionnaires such as
the Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Cohen-Mansfield
Agitation Inventory, Quality of Life – Alzheimer’s Disease (QoL-AD) and the Abbey Pain Scale.
Exhibit 3: Trial design for the CogniCann Phase II in dementia patients
Source: MGC Pharmaceuticals announcement. Note: *Adverse events (AE) will be recorded with each dose in
the titration phase and on the last dose of the intervention phase.
Medicinal cannabis and dementia
Cannabis targets a system in the brain known as the endocannabinoid system, which comprises
receptors called CB1 and CB2. The endocannabinoid system is involved in memory, appetite
regulation and response to stress. Memory loss is a key feature of AD, and agitation and
aggression are commonly observed symptoms in AD and other forms of dementia. This has
prompted a number of investigators to explore the potential for cannabis and cannabinoids to
ameliorate dementia symptoms.