MGC Pharmaceuticals Ltd (ASX:MXC) has received positive results from a pre-clinical in vivo safety and toxicity study, including histology testing, of ArtemiCTM on rats with no pathological changes or differences between the study groups reported.
These positive results demonstrating no pathological impact on major organs of the animals in the study are significant as this completes the FDA requirements for toxicology tests for new drug development.
MGC Pharma co-founder and managing director Roby Zomer said: “The histology results provide the company with important insights into the potential effects of ArtemiCTM on major organs.
“Pleasingly, no adverse impacts were recorded on major organs which provides critical information in relation to planning for future clinical studies.”
Following the safety and toxicity testing completed on mice in July and in line with FDA requirements for product registration requiring two types of rodents in pre-clinical trials, MGC Pharma completed an in vivo safety and toxicity pre-clinical study, including histology testing, on 24 rats.
This included four groups with three 3 study drug dosages being 48ug, 96ug and 196ug per kg rat and a control group.
The rats were observed and tested for clinical changes over seven days which included pathological examination of the organs - liver, heart, brain, spleen, spinal cord, sciatic nerve, kidney (L+R), lungs and tongue.
The results concluded there were no pathological changes in all tested animal samples, which is a promising outcome for the company and its ongoing clinical trial and studies on ArtemiCTM.
ArtemiCTM is designed with the scientific aim to target inflammatory complications due to dysregulation of the immune response (cytokine storm) which may cause organ damage and lung complications from COVID19.
The drug is currently being evaluated in a Phase IIa clinical trial on COVID-19 infected patients in Israel.
This pre-clinical data on rats will support future efficacy clinical studies in Phase IIb and Phase III in COVID-19 patients.
The Phase IIb study will include efficacy endpoints and dose-finding elements, based on these current animal study results.