MGC Pharmaceuticals Ltd progresses clinical trial planning for CimetrA, CannEpil

’s () () () major clinical trial programs planned for CimetrA™, CannEpil® and CogniCann® in 2021 are actively progressing across Australia, Israel and Brazil.

Commencement of the CimetrA Phase III to treat COVID-19 and CannEpil Phase IIb trials for treatment-resistant epilepsy are imminent and all the required regulatory approvals have been received for both.

An application has also been submitted to the Brazilian regulatory agency, ANVISA, to add an additional eight clinical sites to the CimetrA Phase III trial.

“Realise medical and commercial potential”

All three trials are well funded following the successful £6.5mln IPO fundraising and listing on the London Stock Exchange in February 2021.

MGC Pharma co-founder and managing director Roby Zomer said: “All of our clinical trials are progressing well despite the various hurdles we are facing due to the current global situation.

“These trials ensure MGC Pharma and our product offering realise their full medical and commercial potential as we focus on creating new and effective treatments for conditions and diseases that currently have no treatment options.”

The first patients are expected to be enrolled in June 2021 for the Phase III CimetrA and September 2021 for the Phase II CannEpil Epilepsy trial.

CimetrA Phase III controlled clinical study

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).

This trial will enrol a total of 252 patients and will be conducted over a 28-day period.

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, following the receipt of ethics committee approval in 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).

Expanding trial globally

The company intends to expand this trial to strategic global jurisdictions and 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 with the first patient expected to be enrolled in July 2021.

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.

CannEpil Phase IIb trial

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.

The study drug import process has commenced following Israeli Ministry of Health approval.

A total of more than 100 patients will be recruited into the trial, with the trial to be initiated in July and the first patient expected to be enrolled in September 2021.

Interim results of the trial are expected in Q4 2021.

Safety study underway

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 June 2021 and 31 patients are expected to be recruited in October 2021.

CogniCann Phase II clinical trial

The Phase II clinical trial at the University of Notre Dame in Perth, Western Australia has…