European-based biopharma company MGC Pharmaceuticals (ASX:MXC) has just announced exciting further results from the Phase II clinical trials and pre-clinical studies of ArtemiCTM, for the treatment of COVID-19 patients.

These studies are evaluating the efficacy on anti-inflammatory agents for increased cytokine, which is found in different variants and mutations of COVID-19 and post COVID-19 syndrome.

Specifically, the studies are looking to evaluate if ArtemiCTM has the anti-inflammatory effect to prevent cytokine storm.

During a cytokine storm, various inflammatory cytokines are produced at a much higher rate than normal, which leads to organ damage and the main reason for mortality in COVID-19 patients.

Study results

Pre-clinical and clinical results to date, which were carried out in India and Israel, have supported ArtemiCTM as being effective for addressing cytokine in all tested COVID patients.

The pre-clinical trial, called the ARDC model and conducted in mice, is the recommended pre-clinical animal model for the cytokine storm. The ARDC model is used to predict the human model of COVID-19 patients.

In the study, the level of pro-inflammatory markers was measured in blood and BALF (bronchoalveolar lavage fluid) of the mice going through the cytokine storm.

Results from the study have found decreased blood and BALF cytokine levels in the mice, when treated by ArtemiC.

This new finding means that ArtemiC has additional potential applications, with the new data now to be used in the design of future clinical trials by MGC Pharma.

“The findings from the phase II clinical trials are supported by the completed preclinical trial results, and continue to demonstrate the effectiveness of ArtemiC in treating of patients with different variants of COVID-19,”commented Roby Zomer, co-founder and managing director of MGC Pharma.

What’s next

MGC Pharma will continue to develop the preclinical trial on ArtemiC, while also progressing with the clinical development program for its CimetrATM as an Investigational Medicinal Product (IMP).

CimetrA is MGC Pharma’s other trade-marked anti-inflammatory treatment for COVID-19, which was cleared for a Phase III in March.

The Phase III study aims to demonstrate the full efficacy and pharmacokinetic profile of using CimetrA,  and will be used to heighten the drug’s status as an Investigational Medicinal Product (IMP).

Based on the last findings, and as per FDA recommendation, MGC Pharma will initiate a sub-trial for patients who complete the Phase III trial.

The sub-trial will observe patients for an additional three three months to document the post COVID syndrome symptoms, both in the treatment and placebo groups.

The company says that once the inflammation process associated with COVID-19 is under control, the effects of the post COVID syndrome, sometimes called the ‘long COVID, should also be minimised.

MGC Pharma will use this sub-trial and upcoming Phase III clinical trial to prove this very hypothesis, before the commercialisation phase begins.

“We are now looking to get ArtemiCTM into more territories as a supplement and herbal health product following these findings,” Zomer said.