MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, FRA:H5O, ASX:MXC) said ArtemiC, a proprietary nutraceutical food supplement designed to boost the immune system, was approved for sale in the European Union.
It was granted a certificate of free sale in Germany which the company said opens the door to sales in the EU and other international markets.
The product has been shown to be effective in improving and expediting the clinical recovery of patients with mild Coronavirus (COVID-19). Today, new data from a clinical trial of a related product in India has for the first time shown efficacy in patients with severe COVID-19.
"The issue of a Free Trade Certificate for ArtemiC Rescue and the ArtemiC product line in Germany, is a significant step forward for MGC Pharma as it opens the EU to the marketing and sale of one of the company's leading products,” said managing director Roby Zomer. “This is a major commercial milestone for both MGC Pharma and phytomedicines in general, as this approval serves to validate our clinical agenda, and research and development program."
Zomer added: "The latest observational trial results have expanded the possibilities for the use of ArtemiC and CimetrA and their treatment of patients with severe COVID-19.
“MGC Pharma has always placed the treatment of patients at the heart of everything we do, and these results are very promising signs for those who have been most severely impacted by the disease."
CimetrA, released to the Indian study as ArtemiC, was formulated as a nasal spray and was given to 20 hospitalised patients with severe COVID-19 – including ten who were in need of an oxygen supply – in an observational open label controlled clinical trial, as part of the emergency use registration process in India.
MGC said the trial demonstrated a significant reduction in one of the main inflammatory markers related to COVID-19, C-reactive protein (CRP), which is an acute inflammatory protein that increases up to 1,000-fold at sites of infection or inflammation.
The company noted that CRP is used as one of the main prognostic factors for the clinical deterioration in hospitalised COVID-19 patients.
MGC said the finding was significant and expands the potential use of CimetrA and ArtemiC to treat patients with severe COVID-19, and further supports previous preclinical and clinical findings for patients with moderate COVID-19.
The registration process for the emergency use authorisation in India began earlier this month and is expected to be concluded later this year.
ArtemiC is a proprietary nutraceutical supplement that includes four natural based ingredients - Curcumin, Boswellia serrata, Artemisinin and Vitamin C - and incorporates Swiss PharmaCan (TSX-V:MJN)'s MyCell Enhanced delivery system technology.