MGC Pharmaceuticals Limited (LON:MXC) (ASX:MXC) moved higher on Monday after it said it received Ethics Committee approvals from the Rambam Health Care Campus and the Nazareth Hospital EMMS in Israel for Phase III clinical trials of its CimetrA treatment on patients diagnosed with Coronavirus (COVID-19).
The company said the trial will evaluate the efficacy and safety of CimetrA in the treatment of moderate hospitalised patients diagnosed with COVID-19 on a large patient group. This will provide additional data for claims on the product as an Investigational Medicinal Product (IMP) as well as essential data to plan for a future regulatory pathway for the registration of CimetrA as a drug.
The trial is expected to begin in early April and conclude in September, with interim and full results expected in June and October respectively. MGC added that the Phase III trial is currently going through regulatory approvals for additional clinical sites in Israel and Brazil and that it is fully funded to complete the trial following the raising of £6.5mln from its initial public offering on the LSE in February.
In addition to funding, MGC also said it has the facilities, permits and approvals to start production of CimetrA as an IMP, and that it is also planning a development program that will support pre-clinical and clinical trials in additional inflammatory and autoimmune indications.
CimetrA is designed to target viral infections with inflammatory complications and was successfully evaluated on COVID-19 infected patients in a double-blind placebo-controlled Phase II clinical trial.
“This is a very significant milestone for the company being the first Phase III clinical trial of CimetrA. ArtemiC has already proven to be a very successful product for the company, and we look forward to replicating this with CimetrA as an IMP and improve outcomes for COVID-19 patients”, MGC’s managing director and co-founder Roby Zomer said in a statement.
Shares in MGC jumped 7.4% to 4.3p in early trading.