MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has delivered encouraging interim results from the initial 16 patients participating in the CimetrA™ dose-finding study, effective in the prevention of infections from different variants of COVID-19.
The company’s preclinical and clinical results to date have further demonstrated CimetrA's mechanism of action and validated the anti-inflammatory and immune-modulatory effects of the treatment.
Data collected from the 16 patients with COVID-19 who have completed the clinical trial treatment program show that 62.5% of patients in the placebo group reported adverse events related to the symptoms of COVID-19, with no patients from both drug study groups demonstrating any COVID-19-related adverse events.
Results have also shown improvements in multiple parameters measuring the clinical condition of the patient including respiratory rate and oxygen saturation, both of which showed a vector of improvement against the placebo.
Study summary
The ongoing study incorporates key parameters including determining the most effective dosage of the treatment, a full safety and Pharmacovigilance profile, in addition to an extensive Pharmacokinetic profile to outline the registration and administrative process of approval for sale and use.
The study is scheduled to enrol 240 patients currently underway at the Rambam Medical Centre in Israel, with the company planning to open additional sites globally.
Improvement was also observed in trial participants with COVID-19 taking CimetrA in several parameters measuring the clinical condition of the participants, mainly in respiratory rate and oxygen saturation, the most important symptoms of COVID-19.
Forward plan
The study aims to further examine the anti-inflammatory and immune-modulatory effects of CimetrA through Cytokine level monitoring.
Completion of the dosage study is the next phase in moving CimetrA™ towards marketing authorisation as a registered medicine.
CimetrA will undergo a full safety and pharmacokinetic profile to support the administration route as a part of the registration process.
About CimetrA
CimetrA™ is a nanoparticle micellar formulation based on the pharmaceutical synergetic composition consisting of Curcumin and Boswellia.
In clinical trials, CimetrA has demonstrated anti-inflammatory and immunomodulating effects and can be designed for multiple therapeutic applications utilising Graft Polymer IP Ltd's proprietary GraftBio™ Self-nano-emulsifying Drug Delivery System.
Preclinical and clinical results to date have demonstrated CimetrA™'s mechanism of action as an anti-inflammatory and immunomodulatory agent which is effective in the prevention of severe inflammation by its control of increased Cytokine production resulting from an infection of the different variants of SARS-CoV-2 (the virus responsible for COVID19); and which is the forerunner of a Cytokine Storm, which is believed to be the main reason for mortality in severe COVID-19 patients.