MGC expands its ArtemiC clinical trial on patients in Israel and India

MGC Pharmaceuticals, a renowned EU based bio-pharmaceutical firm, has reportedly announced that it has expanded the double-blind, placebo-controlled phase II clinical trial that assesses the efficacy and safety of its anti-inflammatory natural formulation, ArtemiC™, in patients that are diagnosed with COVID-19.

The interim results of its phase II ArtemiC™ clinical trial have fulfilled all the primary efficacy and safety endpoints of treatment within the first 10 trial participants in Israel, also meeting the primary endpoint set by the U.S. FDA.

The trial has now been expanded by MGC to the MGM Hospital in India and the Rambam Hospital in Israel. As per reports, patient recruitment process has begun at Rambam Academic Hospital, which has already enrolled three patients after getting approval from the Ethics Committee.

Meanwhile, the patient recruitment process has been started in India as well. The Mumbai-based Mahatma Gandhi Mission’s Medical College & Hospital, more commonly known as the MGM Hospital, would be the test site for the drug in the country. As per reliable reports, the first patients for the trial in India are expected to begin their treatment courses within days.

The additional trial site locations that are outside of Israel would provide the company with the more extensive statistical data that is needed for it to apply for the marketing authorization of ArtemiC™ to the U.S. FDA (Food and Drug Administration) as well as for the EMA (European Medical Association) registration.

The clinical trial would be assessing the efficacy as well as safety of ArtemiC™, an anti-inflammatory natural formulation that is based upon Artemisinin as well as Curcumin, two natural active ingredients that boast of anti-inflammatory, anti-infective, antioxidant, and immune-modulatory properties. The trial would also assess a unique drug delivery system that further empowers the overall bioactivity of these ingredients.

MGC Pharmaceuticals, MD and co-founder, Roby Zamer, stated that the company is thrilled to begin its phase II clinical trial at MGM Hospital in Mumbai, India as well as expand the trail to the Rambam Hospital in Israel.

Source credit: https://www.proactiveinvestors.com.au/companies/news/930059/mgc-pharmaceuticals-expands-artemic-phase-ii-clinical-trial-on-covid-19-patients-in-israel-and-india-930059.html