ASX-listed MGC Pharma has announced positive results from its latest clinical trial of natural supplement ArtemiC as a treatment for COVID-19.
The phase II double blind trial showed ArtemiC significantly improved the clinical recovery of 50 COVID-19 patients in comparison with a placebo.
All the patients in the treatment group met the trial’s primary end point and fully
recovered within 15 days of follow up.
None of the patients in the treatment group required additional oxygen, mechanical ventilation or admission to intensive care, in comparison with 23.4% of the placebo group requiring further assistance.
The full results improved the health status of COVID-19 patients, delivering a National Early Warning Score (NEWS score) of less than or equal to two. The average NEWS score of patients in the placebo group was 2.25 statistically significantly higher (p<0.04) than in the treatment group – 0.5.
ArtemiC delivered a full safety and efficacy profile, improving and expediting the clinical recovery in moderate COVID-19 patients. The trial met all US FDA requirements for a COVID-19 study including population diversity.
MGC Pharma said the results open potential market opportunities for ArtemiC to a wide range of diseases related to cytokine storm such as autoimmune diseases, inflammatory GI diseases, influenza and chemotherapy patients. Cytokine storm damages the lungs and kills many patients with COVID-19.
Next steps include immediate evaluation of a phase III trial in COVID-19 and influenza patients and classification of ArtemiC under new name IMP (Investigational Medicinal Product), which will be produced in MGC’s European Union GMP facilities.
Following successful phase III trial results, ArtemiC could be produced and sold by MGC as a supplement through its existing production facilities and distribution networks.
MGC Pharma co-founder and managing director Roby Zomer said: “The safety and efficacy demonstrated on COVID-19 patients has now opened the opportunity for a whole range of other indications related to cytokine storm.
“The company will now look to progress the immediate opportunities for ArtemiC while continuing to pursue further clinical developments.”