MGC Pharmaceuticals has received a second human research ethics committee approval in Israel to conduct a clinical trial of natural anti-infective based product ArtemiC in patients with Covid-19.
The approval was provided by the Hillel Yaffe Hospital, while the first approval was from Nazareth Hospital EMMS.
Considered a food supplement, ArtemiC is designed to help address viral infections with inflammatory complications.
The new double-blind, placebo controlled, Phase II trial will assess the safety and efficacy of the drug in Covid-19 patients.
It is expected to start in the coming weeks and will be completed in September this year, with results expected in October. The trial will enrol a total of 50 patients across two sites.
MGC Pharmaceuticals said in a statement: “The trial will evaluate the safety and efficacy of the product, and determine the claims which the product will be able to be sold as a food supplement. Importantly, MGC will own the intellectual property generated from the trial.
“The results from the trial will determine the valid claims that can be made in relation to the product, provide data points for future trials and will be material to the commercial discussions the company is currently undertaking with respect to potential supply and sale agreements of the product in the short term.”
The second site is intended to support the previous approval by offering wider statistical data to help in deciding on further testing for potential marketing authorisation approval.
MGC added that available scientific data on Artemisinin and Curcumin properties supports testing of ArtemiC in Covid-19 patients.
The company will also carry out research, manufacture and packaging for commercial orders from its operational facilities in Europe. It also has the approvals to start commercial production.