MGC Pharmaceuticals (MGC Pharma) has obtained study and importation approval from the South African Health Products Regulatory Authority to conduct the Phase IIb dose-finding clinical trial of CimetrA in Covid-19 patients.
A nanoparticle micellar formulation, CimetrA is based on the pharmaceutical synergetic composition comprising Curcumin and Boswellia.
The trial in South Africa is an expansion of the dosing trial presently progressing in a site at Rambam Medical Center, Haifa, Israel, with interim assessment data expected soon.
It will incorporate key parameters, including detecting the most effective dose of CimetrA, a complete safety and Pharmacovigilance profile and an extensive Pharmacokinetic profile of the drug to plan the registration and administrative process to obtain approval for sale and usage.
In addition, the anti-inflammatory and immune-modulatory effects of CimetrA via Cytokine level monitoring will be evaluated in the trial.
The company noted that the launch of this South African trial site will aid in expediting the completion of the trial and collection of data needed for the submission of CimetrA with regulatory agencies globally.
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MGC Pharmaceuticals co-founder and managing director Roby Zomer said: “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.”
In a double-blind, placebo-controlled Phase II trial, CimetrA demonstrated immunomodulatory and anti-inflammatory effects in moderate Covid-19 patients.