Interim results show MGC Pharma’s CimetrA dose finding study on right track
Health & Biotech
Health & Biotech
While early days, MGC Pharmaceuticals is encouraged by interim results in the CimetrA dose finding study, key to moving the drug towards marketing authorisation as a registered medicine.
European based Biopharma MGC Pharmaceuticals (ASX:MXC) (LON:MXC) has released positive interim results from the data collected from the initial 16 patients participating in the CimetrA dose finding study.
The study is underway to determine the most effective concentrations of active ingredients for dosage, as well as further validate the anti-inflammatory and immune-modulatory effects of the treatment.
The interim results 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..
Improvement was also observed in trial participants with COVID-19 taking CimetrA in several parameters measuring the clinical condition of the participants.
The improvements were mainly in respiratory rate and oxygen saturation, the most important symptoms of COVID-19.
The study will be used to find the most effective concentrations of the active ingredients for dosage, as well as further validating the anti-inflammatory and immune-modulatory effects of CimetrA.
The ongoing study, which is scheduled to enrol 240 patients is underway at the Rambam Medical Centre in Israel, with the MXC planning to open additional sites globally. There are currently a further 24 patients actively participating in the study.
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.
Whilst MXC said the sample size on which the interim analysis has been performed is small and cannot be used for Inferential statistical analysis, the results so far are encouraging and in line with expectations.
The full study incorporates key parameters including determining the most effective dosage of the treatment.
A full safety and pharmacovigilance profile will be undertaken in addition to an extensive pharmacokinetic profile to outline the registration and administrative process of approval for sale and use.
The study aims to further examine the anti-inflammatory and immune-modulatory effects of CimetrA through cytokine level monitoring.
In previous studies, CimetrA has demonstrated anti-inflammatory and immuno-modulating effects, based on curcumin and boswellia as anti-inflammatory agents, which are well-known natural active ingredients with immunomodulatory properties.
Preclinical and clinical results to date have demonstrated CimetrA as effective in the prevention of severe inflammation by controlling increased cytokine production, found in different variants and mutations of covid-19.
Increased cytokine production is the forerunner of cytokine storm, which is believed to be a main reason for deaths in patients with severe COVID-19.
MXC has taken a strategic 40% stake in Zam Software Ltd, the UK-incorporated owner of proprietary Artificial Intelligence data gathering platform, ZAM.
The Company believes that the ZAM app is a potential game changer in the industry as it enables the possibility of personalising medication.
This article was developed in collaboration with MGC Pharmaceuticals, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.