MGC Pharma has concluded the Phase II Trial of its novel anti-inflammatory formula 'ArtemiC,' which is designed to treat patients suffering from COVID-19.
MGC Pharmaceuticals Ltd (ASX: MXC) today announced that the company had completed its Phase II double-blind, placebo-controlled clinical trial involving 50 participants for ArtemiC, MGC's anti-inflammatory formulation designed to treat patients with COVID-19.
The clinical trial was designed to determine the safety and efficacy of ArtemiC, as well as meeting the FDA primary endpoint of establishing a sustained critical recovery & a reduced need for patients to require sustained clinical recovery.
The results of MGC's ArtemiC Clinical Trial are scheduled to be published within a month after they're independently reviewed by an external Clinical Research Organisation in accordance with FDA and GCP guidelines.
According to MGC Pharma: "Should the full Trial results validate data received from the Interim Results, the Company is well- positioned to fast-track production of ArtemiCTM immediately as a food supplement to meet the expected demand for potential material contract supply opportunities."
MGC plans to progress to a Phase III Clinical Trial upon the receipt of the Phase II trial results, to move full-steam-ahead in the company's fight to help mitigate the COVID-19 pandemic.
MGC also mentions in its recent Press Release that "According to the World Health Organisation's weekly situation report there have been over 3 million new cases in the past 7 days, the highest number of weekly new COVID-19 cases reported globally since the outbreak."
Dr Jonathan Grunfeld, Chief Medical Officer of MGC Pharma, commented: "ArtemiC is a formulation comprising several active ingredients, each of which is associated with multiple therapeutically relevant biological effects. The logic embodied in the ArtemiC clinical approach may be metaphorically represented in the concept of a "Silver Blanket" in contradistinction to the "Silver Bullet" solution approach."
"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. 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," Mr. Grunfeld continued.
"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."
Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: "We are very pleased to announce the completion of the Phase II clinical trial for ArtemiC.
The second wave of the pandemic is again putting increased pressure on a number of healthcare systems around the world. Roby Zomer, Co-founder and Managing Director of MGC Pharma
"We look forward to announcing the full results of this trial in the coming weeks and will continue to progress this important clinical trial work," Mr. Zomer concluded.
To learn more about MGC Pharma, visit their company HQ here.
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