Cannabis giant MGC Pharmaceuticals has received approval for a phase three clinical trial in patients with Covid-19.
The European based bio-pharma company has been given the go-head to evaluate the efficacy and safety of CimetrATM as a treatment for moderate hospitalised patients diagnosed with COVID-19.
The company received Ethics Committee approval from Rambam Health Care Campus and Nazareth Hospital EMMS in Israel, to conduct a Phase III Clinical Trial.
This is now scheduled to commence in early April, and will provide essential data to plan for the potential future registration of CimetrATM as a drug.
CimetrATM is designed to target viral infections with inflammatory complications and was successfully evaluated on COVID-19 patients in a double-blind placebo controlled, Phase II clinical trial.
Under the move to a Phase III clinical trial, the classification of the product has changed from a food supplement to an IMP. As a result, the product name under the Trial has changed from ArtemiCTM to CimetrATM.
In February, MGC which specialises in the production and development of phyto-derived medicines, became the first cannabis company to list on the London Stock Exchange and is fully funded to complete the trial after raising £6.5million.
The trial is designed to test CimetrATM on moderate hospitalised patients infected with COVID-19 for safety and efficacy, with the purpose of treating the pathophysiological repercussions of infection with the coronavirus.
Researchers will assess the efficacy and safety of the natural anti-inflammatory formulation CimetrA™, based on Curcumin and Boswellia Serrata as Anti-inflammatory agents with the supporting ingredient Artemisinin as an Antiseptic peroxide bridge, which are all well-known natural active ingredients with immunomodulatory properties.
A total of 252 patients infected with COVID-19, across clinical sites in Israel and Brazil, will be evaluated, over a period of 28 days per patient.
Interim results are expected to be published in June 2021, before the trial concludes in September and full results become available during October.
Roby Zomer, co-founder and managing director of MGC Pharma, commented: “This is a very significant milestone for the company being the first Phase III clinical trial of CimetrATM.
ArtemiCTM has already proven to be a very successful product for the Company, and we look forward to replicating this with CimetrATM as an IMP and improve outcomes for COVID-19 patients.”
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