European-based biopharma company MGC Pharmaceuticals (ASX:MXC) has continued to make progress on its major clinical trials planned for 2021.

The company has provided an update on the soon-to-commence clinical trials in CimetrA, CannEpil, and CogniCann – with all three actively progressing well across Australia, Israel and Brazil.

All required regulatory approvals have now been received for both the CimetrA and CannEpil, with the first patients to be enrolled in June and September respectively.

An additional trial focused on the safety of CannEpil has also been approved and initiated in Australia.

For CogniCann, the Phase II clinical trial conducted in Perth has already recruited 21 of the targeted 50 patients.

All three trials are well funded, following the recently successful GBP 6.5 million IPO fundraising, and MGC’s subsequent listing on the London Stock Exchange in February.

“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,” says CEO and co-founder of MGC Pharma, Roby Zomer.
 

CimetrA Phase III clinical study

The Phase III clinical trial of CimetrA was designed to evaluate the efficacy and safety of the drug for hospitalised patients diagnosed with COVID-19.

It will also provide additional data for claims on the product as an Investigational Medicinal Product (IMP) – a designation it received from the Rambam Health Care Campus, and Nazareth Hospital in Israel.

The Israeli Ministry of Health has now approved the clinical trial, which will shortly commence at the two hospitals.

The trial will enrol a total of 252 patients, and will be conducted over a 28-day period, with the first patient to be enrolled in June.

MGC Pharma intends to expand this trial to other strategic global jurisdictions, with an application for eight additional clinical sites in Brazil already being submitted to the Brazilian regulatory agency, ANVISA.

The first patient in Brazil is expected to be enrolled in July 2021, after approval is obtained.

The soon-to-commence trial in Israel has experienced delays in enrolling the first patient due to logistical issues in obtaining the key ingredients for CimetrA. This was due to import and logistical restrictions after the COVID-19 outbreak.

However, MGC has emphasised this will not affect the development of the drug, with interim results from the trials expected to be released in August, and final results in Q4 of 2021.
 

CannEpil Phase IIb clinical study

The phase IIb clinical trial of CannEpil will take place at the Schindler Hospital in Israel.

The study will focus on the safety and efficacy of CannEpil as an add-on treatment in children and adolescents with refractory epilepsy.

The trial will commence in July, with more than 100 patients to be recruited starting in June after obtaining an approval from the Israeli Ministry of Health.

MGC has also initiated a study of CannEpil in Australia, to demonstrate the safety of the drugs when used by drivers.

The Driving Safety study of CannEpil in Australia was conducted following the reopening of universities after the COVID-19 lockdowns.

This trial will involve 31 healthy volunteers to be recruited by October, and aims to provide supportive safety data to the Austalian regulatory authorities.
 

CogniCann Phase II clinical trial

Finally, the Phase II clinical trial of CogniCann will be conducted at the University of Notre Dame in Perth.

This study will evaluate the potential behavioural benefits of CogniCann on patients with dementia and Alzheimer’s disease.

Initial recruitment had actually been started in January 2020, but was temporarily suspended due to the COVID-19 restrictions in WA.

Recruitment has now re-commenced, with 21 patients enrolled in the trial over the last three months, out of a target of 50 patients.

Interim results from this study are expected to be released in Q4 of 2021.

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