LONDON: MGC Pharmaceuticals Ltd (ASX: MXC), a European based bio-pharma company specialising in the production and development of phytocannabinoid-derived medicines, announced further results from the Phase II clinical and preclinical studies on ArtemiC, 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.
Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: “The findings from the phase II clinical trials which are supported by the completed preclinical trial results, continue to demonstrate the effectiveness of ArtemiC in treating patients with different variants of COVID-19.
“We are now looking to get ArtemiC into more territories as a supplement and herbal health product following these findings.”
The mechanism of action of ArtemiC is focused on the anti-inflammatory effect and prevention of cytokine storm – believed to be the main reason for mortality in COVID-19 patients.
Preclinical and clinical results to date support ArtemiC being effective for addressing cytokine over production in all tested COVID patients. On 15 December 2020, the Company released to the ASX results from its Phase II clinical trial results from patients in India and Israel.
The preclinical trial “Evaluation the Efficacy of Artemic Treatment in ARDS Model in Mice” was performed in the SIA preclinical Lab (GLP certified) in Israel.
The ARDC model is the recommended preclinical animal model for the cytokine storm for the prediction of the human model of COVID-19 patients. The level of the pro-inflammatory markers was measured in blood and BALF (bronchoalveolar lavage fluid) of the mice going through the cytokine storm.
The results demonstrated decreased blood and BALF cytokine levels in the study arm treated by ArtemicTM.
These findings support the understanding of the mechanism of action of ArtemiC and additional potential application of the study product. This data will be used in the design of future clinical trials of the Company in different indications.
Following the successful Phase II clinical trial results (refer ASX release 15 December 2020), ArtemiC demonstrated efficacy in COVID-19 infected patients. Patients in the treatment group fully clinically recovered within 15 days of follow up. The ArtemiC results delivered a full safety and efficacy profile, demonstrating its ability to improve and expedite the clinical recovery in mild and moderate COVID-19 patients.
MGC Pharma (ASX: MXC) continues the preclinical development on ArtemiC while progressing with the clinical development program for CimetrA as an Investigational Medicinal Product (IMP) to demonstrate the full efficacy and pharmacokinetic profile of the treatment in a Phase III clinical trial (submitted on the clinical drug development program of IMP version of ArtemiC).
Importantly once the inflammation process associated with COVID-19 is under control, the effects of ‘long COVID’, the post COVID syndrome should be minimised. MGC Pharma will initiate a sub-trial in combination with the upcoming Phase III clinical trial to prove this hypothesis.
As per the FDA recommendations and based on the last findings, MGC Pharma will initiate a sub-trial for patients who complete the Phase III trial, observing them for an additional three (3) months to document the post COVID syndrome symptoms both in the treatment and placebo groups.
MGC Pharmaceuticals Ltd
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5 May, 4:10 pm GMT+10 · Disclaimer