Clinical Trials

MGC Pharmaceuticals Ltd currently has three vital clinical trials in progress and a robust preclinical pipeline to support future development.

Supporting multiple products enroute to central market authorisation

While enhancing the available research and evidence to support wider scale implementation of both plant-based and cannabinoid focused treatments.
MGC’s robust preclinical pipeline ensures future growth for the company as well as deepening the areas of engagement where we believe plant based medicines will have the most significant impact.

Leading the global shift towards plant-based, naturally harmonious medicines, improving lives and public health.

Artemic

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:

  • 100% met all FDA primary and secondary end points
  • Improved clinical recovery
  • Improvement of symptoms and pain
  • Faster overall recovery time
  • No requirement for additional medical assistance (ICU, ventilation

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). The first patient is expected to be enrolled during June 2021, following the completion of CimetrA™ IMP Production and validation (from supplement production).

The Company intends to expand this trial to strategic global jurisdictions, and as such has submitted an application for eight additional clinical sites in Brazil. MGC Pharma is working with the Brazilian regulatory agency, ANVISA, in order to obtain the final approvals required to progress with the study. The first patient in Brazil is expected to be enrolled in July 2021.

The recent delay in the enrolment of the first patient due in for the Phase III trial is a result of logistical issues surrounding obtaining bulk supply of a key ingredient for CimetrA™ owing to the COVID-19 outbreak. It has not affected the continued development of the drug which has continued parallel to the Phase III trial planning.

Interim results of the trial are expected to be released in August 2021 and the trial is expected to complete with final results due in Q4 2021.

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 Q4 2021.

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 Q4 2021.

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 November2021. Interim results of the trial are expected in Q2 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.

The first patient is expected to be recruited in November 2021.