MGC Pharma will now carry out its Phase 2b CimetrA dose-finding study on patients diagnosed with Covid-19.
MGC Pharmaceuticals has received study approvals and an import permit from the South African Health Products Regulatory Authority.
The company, which focuses on the development of phytomedicines including cannabinoid medicines, will be investigating its formula – CimetrA – which is designed with the aim of targeting the effects of viral infections with associated inflammatory complications.
MGC Pharma has stated it has successfully demonstrated its immunomodulatory and anti-inflammatory effects on patients with moderate Covid-19, in a double-blind placebo-controlled, Phase 2 clinical trial.
Co-founder and managing director of MGC Pharmaceuticals, Roby Zomer, commented: “With Covid-19 cases once again on the rise, the extension of the CimetrA dosage trial into South Africa could not be more important.
“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.”
The study aims to determine the most effective dosage concentrations of the active ingredients, as well as to collect data to further validate CimetrA’s anti-inflammatory and immune-modulatory effects.
The trial will provide additional data for claims on the product as an Investigational Medical Product (IMP) and provide essential data to plan the future regulatory pathway for the registration of CimetrA as a drug.
The South African study site adds to the existing site at Rambam Medical Center, Haifa, Israel, which has been recruiting patients since 2021, with interim analysis results expected in the coming weeks.
MGC Pharma has stated it is also collecting data related to Long-Covid, one of the main complications of the disease, with findings to be released shortly, and that it is planning to develop a clinical programme for other inflammatory indications to determine the efficacy of CimetrA on these conditions.
The establishment of the South African trial site will help to accelerate the completion of the ongoing study, and the collection of data necessary for the submission of CimetrA with regulators internationally.