MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) said plans with partner AMC Holdings Inc are progressing for the first US-based clinical trial of its phytomedicine CimetrA in the third quarter of this year.
Following the signing of a deal last August with US drug distributor AMC, worth a minimum of US$24mln over the next three years, MGC said it is this week holding discussions with the University of South Florida (USF) to finalise plans for the trial.
The timing, commitment and logistics were all confirmed with USF’s Medical and Pharmacology School and its Botanical Medicine Research and Education Consortium, which will undertake the trials.
Work at USF is designed to add further weight to the clinical research on CimetrA, a natural medicine comprised of boswellia and curcumin, that has been carried out to date in Israel and India.
MGC Pharma chief executive Roby Zomer said: “We are excited to start the trials in collaboration with USF at the earliest opportunity this year, particularly with COVID-19 spikes and new variants emerging every few months.
“We are looking forward to working with our US distribution partners, AMC, to bring CimetrA to the US market, where we believe there is a real need, and expect the treatment to be well received.
“This is an important and exciting agreement for MGC Pharma, providing access to the largest healthcare market in the world, and we are looking forward to working with AMC, utilising their expertise and network to widen patient access to MGC's phyto-medicine products. "
A Phase II double-blind clinical trial of CimetrA in 2020, for example, showed the efficacy of the treatment for patients suffering from moderate COVID-19, with none of the patients in the treatment group requiring additional oxygen, mechanical ventilation, or admission to intensive care, in comparison with 23.4% of the placebo group requiring further assistance.
MGC says the medicine can be self-administered as an oral spray where it is delivered to the oral mucosal cells and is most efficiently absorbed into the body in a highly concentrated form, without first being degraded by amino acids in the stomach or absorbed through the stomach lining, and is "variant agnostic" so it helps the body respond to the virus infection rather than acting as an anti-viral, which often has more efficacy against one variant than another.