MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has received study approvals and an import permit from the South African Health Products Regulatory Authority for a Phase 2b CimetrA™ dose-finding study in patients diagnosed with COVID-19.
The company designed CimetrA to target the effects of viral infections and the associated inflammatory complications.
MGX previously demonstrated the immunomodulatory and anti-inflammatory effects on patients with moderate COVID-19 in a double-blind placebo-controlled Phase 2 clinical trial.
This Phase 2b study will be used to determine the most effective dosage concentrations and collect further validating data to support CimetrA’s anti-viral effects.
MGX will use this data to reinforce claims on the treatment as an investigational medical product (IMP) and map a regulatory pathway for the registration of CimetrA as a drug.
Completion of dosage trials “crucial”
“With COVID-19 cases once again on the rise, the extension of the CimetrA dosage trial into South Africa could not be more important,” MGC Pharmaceuticals managing director and co-founder Roby Zomer said.
“Clinical trials to date have demonstrated the efficacy of CimetrA against COVID-19, so it is crucial that we are able to complete the dosage trials in Israel and now South Africa as quickly as possible so we can move to the next stage of the clinical pipeline and treat those suffering from the effects of the cytokine storm and 'Long COVID' more effectively.”
Interim results from the initial study site at the Rambam Medical Center in Haifa, Israel, are expected in the coming weeks.
MGC Pharma is also collecting data related to Long COVID, one of the main complications of the disease, with findings to be released shortly.
Based on recently released results from a preclinical study determining the mechanism of action of CimetrA, MGX intends to develop a clinical program for other indications to determine the efficacy of CimetrA on these conditions.
Results have so far indicated CimetrA could be used to treat a wide spectrum of inflammatory and autoimmune diseases, such as inflammatory bowel disease (IBD), rheumatoid arthritis (RA), influenza, and dermatological diseases, among others.