MGC Pharma set to commence Phase III clinical trial on CimetrA to treat COVID-19 patients
Health & Biotech
Health & Biotech
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European-based biopharma company MGC Pharma (ASX:MXC) has officially commenced the Phase III clinical trial to evaluate the efficacy and safety of its COVID-19 drug, CimetrA.
The clinical trial is aimed at providing additional data to support claims on the drug as an IMP (Investigational Medicinal Product), and as a treatment for hospitalised patients diagnosed with COVID-19.
The Phase III trial follows the completion of CimetrA IMP production and validation, as well as an ethics committee approval which was received in March this year.
As the trial commences, MGC Pharma will seek to complete all the required clinical data for meeting the European Medicines Agency’s (EMA) requirements.
This will include submitting additional pre-clinical and dose-finding studies along with the Phase III results.
The Phase III clinical trial is designed to test CimetrA on moderate hospitalised patients infected with COVID-19 for safety and efficacy, with the purpose of treating the pathophysiological repercussions of infection with the novel coronavirus 2019 (SARS-CoV19).
Specifically, the trial will assess the natural anti-inflammatory formulation CimetrA, based on Curcumin and Boswellia Serrata as anti-inflammatory agents – which are all well-known natural active ingredients with immunomodulatory properties.
As part of the trial, CimetrA will also incorporate a new polymeric drug carrier, GraftBio (SNEDD – Self Nano Drug Delivery), to deliver natural ingredients more effectively in higher concentrations to the cells, which will improve bioavailability and synergy of the natural active ingredients.
At the conclusion of the trial, MGC Pharma will own all intellectual property generated, with the results determining what valid claims can be made in relation to the product.
The results will also provide data points for future trials, and are important to the commercial discussions the company is currently undertaking.
Recruitment of of 252 patients is about to start, each of whom will be enrolled for 28 days to be conducted at the Rambam Health Care Campus and Nazareth Hospital EMMS in Israel.
“The commencement of the Phase III clinical trial is a milestone achievement for both MGC Pharma and the medicinal cannabis industry,” commented Roby Zomer, co-founder CEO of MGC Pharma.
“Testing CimetrA as an IMP will have great implications for those suffering with COVID-19 and ensure the risk of healthcare systems becoming overwhelmed is minimised.”
Apart from CimetrA, MGC Pharma is also embarking on an aggressive strategy of conducting multiple clinical trials in other drugs, all set to commence in 2021.
The phase IIb clinical trial of CannEpil is set 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 refractory epilepsy.
Meanwhile, the Phase II clinical trial of CogniCann will be conducted at the University of Notre Dame in Perth, and will evaluate the potential behavioural benefits of CogniCann on patients with dementia and Alzheimer’s disease.