ArtemiC was tested for safety and efficacy in a double-blind, placebo-controlled clinical trial involving 50 patients diagnosed with COVID-19.
In a Phase II clinical trials, ArtemiC statistically improved the recovery of patients infected with COVID-19. All patients had a confirmed COVID-19 infection, were hospitalized in a stable, moderate condition and were between the ages of 40 and 75. By the end of the two-week trial, 100% of the patients in the treatment group had shown improvement.
Within 15 days of follow-up, all had fully recovered. No patients in the treatment group required additional medical intervention and no adverse reactions to the treatment were recorded.
Those who were treated with ArtemiC showed:
MGC Pharma’s phase III clinical trial has been designed to evaluate the efficacy and safety of CimetrA™ as a treatment for hospitalised patients diagnosed with COVID-19, and to provide additional data for claims on the product as an Investigational Medicinal Product (IMP). The trial will enrol a total of 252 patients and will be conducted over a 28-day period.
The Israeli Ministry of Health approval has now been received and the trial will shortly be initiated at the two clinical sites, Rambam Health Care Campus and Nazareth Hospital EMMS in Israel. This follows receipt of ethics committee approval in March 2021 (see ASX announcement 23 March 2021).
Interim results of the trial were expected to be released in August 2021. However, the Company is currently enrolling patients into a Phase IIb Dosing Study for CimetrA, which aims to determine the optimum dosage of CimetrA to treat
patients suffering from COVID-19, with these results to inform the dosage used in the Phase III trial.
Once enrolments into the Phase III trial recommence, the company intends to expand this trial to strategic global jurisdictions.
CogniCann® – Phase II clinical trial
The Phase II clinical trial at the University of Notre Dame in Perth, Western Australia has been designed to evaluate the potential behavioral benefits of CogniCann® on patients with dementia and Alzheimer’s disease. The trial will enrol 50 patients and is expected to last until Q2 2022.
Initial recruitment commenced in January 2020 but was temporarily suspended due to the COVID-19 restrictions in WA. Recruit has recommenced and 21 patients have been enrolled in the trial over the last three months. Interim results are expected to be released in Q2 2022.
All three trials are well funded, following the successful £6.5 million IPO fundraising and listing on the London Stock Exchange in February 2021, and the Company will make further updates on them in due course.
CannEpil® (MGCND00EP1) – Phase IIb randomised, double blind, placebo controlled clinical study.
The phase IIb clinical trial will take place at the Schindler Hospital in Israel and will focus on the safety and efficacy of CannEpil® as an add-on treatment in children and adolescents with treatment resistant epilepsy, also known as refractory epilepsy. A total of more than 100 patients will be recruited into the trial.
The study drug import process has commenced following Israeli Ministry of Health approval. The trial will be initiated in July and the first patient is expected to be enrolled in June 2022. Interim results of the trial are expected in Q4 2022.
MGC has already initiated a Driving Safety study of CannEpil® in Australia following the reopening of universities after the COVID-19 lockdowns. This trial involves healthy volunteers and aims to demonstrate the safety of CannEpil® in order to provide supportive data to the regulatory authorities.