MGC Pharma closer to anti-inflammatory medicine for COVID after phase two clinical trial
Health & Biotech
Health & Biotech
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MGC Pharmaceuticals (ASX:MXC) has successfully completed a phase two clinical trial for its anti-inflammatory medicine on 50 patients diagnosed with COVID-19 that is designed to evaluate their recovery rates.
Full results of the clinical trial will be published in December following an independent technical review and statistical validation of the trial data.
MGC Pharma has potential commercial contract opportunities lined up for its anti-inflammatory medicine pending the publication of the clinical trial results.
The clinical test was designed to evaluate the safety and efficacy of MGC Pharma’s anti-inflammatory medicine which reduces the immune system’s inflammatory response to the virus, known as a cytokine storm.
MGC Pharma chief executive, Roby Zomer, said he was pleased to announce the completion of the trial.
“We look forward to announcing the full results of this trial in coming weeks and will continue to progress this important clinical trial work,” he said.
The biopharma company plans to embark on a phase three clinical trial for its anti-inflammatory medicine that will involve an international multi-centre study according to Food and Drug Administration (FDA) guidelines.
The effective treatment of symptoms of COVID-19 has been deemed important by the FDA which oversees clinical trials for new medical treatments.
The biopharma company said it is now in a strong position to fast-track production of its anti-inflammatory medicine and to meet rapidly evolving demand for COVID-19 treatments.
“The second wave of the pandemic is again putting increased pressure on a number of healthcare systems around the world,” Zomer said.
Around 3 million new cases of COVID-19 have been reported to health authorities globally in the past seven days, according to the World Health Organisation’s weekly update.
There is also an immediate opportunity to pursue commercial agreements for its anti-inflammatory medicine with Europe, Russia, Israel and the UK and US amid a second wave of outbreaks of the COVID-19 virus.
MGC Pharma’s anti-inflammatory medicine is represented as a ‘silver blanket’ in the fight against COVID-19.
The company’s chief medical officer, Dr Jonathan Grunfeld, explained the workings of the treatment:
“The idea is to simultaneously obstruct multiple processes driving the disease in an attempt to smother its progression rather than precisely disrupt specific processes considered to be crucial to its further development,” he said.
Alternative ‘silver bullet’ medical approaches to treating COVID-19 had proved ineffective, he said.
“The experience accumulated so far with ‘silver bullet’ therapeutics such as specific disruption of isolated cytokine activities or distinct molecular events required for viral penetration into cells of the lungs or replication, and so on, have all failed to provide a satisfactory remedy for COVID-19.”
Fifty patients infected with COVID-19 were involved in the double-blind placebo-controlled phase-two clinical trial which follows an earlier initial study.
A key objective of the clinical trial was to prevent the need for high-risk patients entering intensive care or requiring invasive mechanical ventilation.
The study was managed by an external Clinical Research Organisation under strict regulatory conditions under FDA and Good Clinical Practice protocols.
The first study involved 10 COVID-19 patients at two hospitals in Israel and showed MGC Pharma’s medicine met all of the primary end points for treatment safety and efficacy.
Data from the initial study showed MGC Pharma’s anti-inflammatory medicine had a beneficial effect on patient pain associated with COVID-19.
FDA guidelines for COVID-19 clinical trials require patients to show a sustained recovery, a resolution of symptoms, and the prevention of intensive care or invasive ventilation for high-risk patients.
MGC Pharma is in the process of designing protocols and parameters for a next phase, international multi-centre clinical trial with endpoints and a study population in line with FDA guidelines.
The company has started shipping its products to countries including Brazil, Russia and the UK under distribution agreements.
MGC Pharma has enhanced its intellectual property with the launch of its CannEpil App for patients of its cannabinoid medicine products.