MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) said results from a recently completed phase II trial of its dementia treatment CogniCann showed the drug can inhibit the deterioration of behaviour in dementia patients.
CogniCann is an oral spray containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
In the phase II clinical study, undertaken in conjunction with the University of Notre Dame in Western Australia, eligible patients commenced a six-week treatment course with CogniCann before switching to a six-week course of placebo, with a two-week 'washout' period between the two courses, MGC said in a statement.
The study showed that CogniCann was safe to use by patients with dementia.
It also demonstrated that while patients in the placebo group experienced a deterioration in their condition after 44 days, patients treated with CogniCann were stable, indicating the early-stage use of CogniCann may be beneficial in the treatment of dementia patients.
Aggressive behaviour, measured using the Cohen-Mansfield Agitation Inventory (CMAI) scale, improved by 13% in the treatment group during the 44-day study, compared with 4% improvement in the placebo group.
“This important finding indicates not only improvement in the health status of the patients, but also the improved quality of life of the families and caregivers that are taking care of dementia patients,” MGC said.
Agitated behaviours also improved in the treatment group, compared with the placebo group, it added.
It is estimated that nearly 787,000 people in the UK and 450,000 people in Australia suffer from Alzheimer's disease, with approximately 78% of these having mild or moderate symptoms. In the top four European countries, this number is closer to 1 million and is expected to grow by 15% by 2024.
The CogniCann clinical trial, which began in March 2020, had initially planned to enrol 50 patients from a number of aged care facilities across Perth, Western Australia. The emergence of Covid-19 and the resulting restrictions on care facilities meant it took longer than expected to complete the trial and the number of patients enrolled in the study was reduced from 50 to 22.
MGC said results from the phase II study will be used in the design of the next phase of clinical trials for CogniCann, including defining the appropriate end points and patient sample size.
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