MGC Pharmaceuticals completes ArtemiC Phase II clinical trial on COVID-19 infected patients, final results next month

MGC Pharmaceuticals Ltd (ASX:MXC) (OTCMKTS:MGCLF) (FRA:MGC) has completed its 50-patient Phase II double-blind, placebo-controlled clinical trial for anti-inflammatory treatment, ArtemiC, on patients diagnosed with COVID-19 to evaluate its safety and efficacy.  Final results of the clinical trial are expected to be published next month following independent technical review and statistical validation of the trial data.  The European-based biopharma company specialising in the production and development of phytocannabinoid-derived medicines, believes positive results from the trial have the potential to deliver material commercial supply opportunities for ArtemiC immediately as a food supplement. It is now designing protocols and parameters for the next phase of the international multi-centre clinical trial with endpoints and study population to be defined by the US Food and Drugs Administration (FDA) guidelines. Progress clinical trial work MGC Pharma co-founder and managing director Roby Zomer said: “The second wave of the pandemic is again putting increased pressure on a number of healthcare systems around the world. “We look forward to announcing full results of this trial in the coming weeks and will continue to progress this important clinical trial work.” ‘Silver blanket’ solution approach MGC Pharma chief medical officer Dr Jonathan Grunfeld said: “The logic embodied in the ArtemiC clinical approach may be metaphorically represented in a concept of a 'Silver Blanket' in contra-distinction to the 'Silver Bullet' solution approach. “The idea is to simultaneously obstruct multiple processes driving the disease in attempt to smother its progression rather than precisely disrupt specific processes considered to be crucial to its further development. “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. “The shortcoming of this approach has already gained recognition in attempts to combine more than one 'Silver Bullet' in recently designed protocols. “ArtemiC takes the ‘Silver Blanket’ approach one step further in that it combines ingredients with pleiotropic effects.” Fast-track production MGC Pharma is well-positioned to fast-track the production of ArtemiC to meet future demand post-publication of full clinical trial results, with potential for material commercial contract supply opportunities on the back of positive results from the full trial validating the interim results. There is immediate opportunity to pursue commercial supply agreements with the second wave of the COVID-19 pandemic currently across the UK, Americas, Europe, Russia/CIS countries, Israel and the Middle East. A total of 3,355,265 new cases of COVID-19 have been reported globally in the last seven days, according to the World Health Organisation’s weekly situation report. Interim results from the first 10 patients in Israel met all primary endpoints for the safety and efficacy of the treatment. They met key FDA primary endpoint of sustained clinical recovery, preventing the need of intensive care in high-risk patients or invasive mechanical ventilation.