MGC Pharmaceuticals receives go-ahead for Phase III trial of COVID-19 treatment

Medicinal cannabis biotech company MGC Pharmaceuticals (ASX:MXC) can proceed to a Phase III clinical trial of its anti-inflammatory medicine for the treatment of COVID-19.

Ethics committees at Nazareth Hospital and the Rambam Health Care Campus in Haifa, Israel, have approved the clinical trial on patients diagnosed with COVID-19.

The treatment 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 trial late last year.

“This is a very significant milestone for the company being the first Phase III clinical trial of the anti-inflammatory medicine which has already proven to be a very successful product for the company, and we look forward to replicating this with CimetrA as an investigatory medicinal product,” co-founder and managing director, Roby Zomer, said.

MGC Pharma has a significant cash reserve for the development of its medicinal products after its IPO and share listing on the London Stock Exchange that raised $11.6m.

Efficacy and safety evaluated in trials

The Phase III clinical trial at the two Israeli hospitals will evaluate the efficacy and safety of MGC Pharma’s anti-inflammatory medicine in the treatment of a large group of hospitalised patients with COVID-19 of around 250 in number across sites in Brazil in Israel.

Rambam Health Care Campus is a 1,000-bed world-class government teaching hospital and the major medical centre for 2 million residents in northern Israel and also receives patient referrals from the Mediterranean region and around the world.

Nazareth Hospital is one of the oldest hospitals in the Middle East and a general hospital with an accident and emergency department, orthopaedic, paediatric unit and urology unit.

The protocols for the clinical trial were finalised by MGC Pharma’s Clinical Advisory Team led by doctors Grunfeld and Lisovoder and have been provided to the hospitals’ ethics committees.

SNEDDS unique delivery platform

MGC Pharma last month struck a three-year worldwide supply and distribution agreement with Swiss Pharmacann for its anti-inflammatory medicinal cannabis product that can be used to treat COVID-19.

The anti-inflammatory treatment has been elevated to an investigational medicinal product under the Phase III clinical trial and was previously classified as a food supplement.

The medicine incorporates a unique delivery platform for active ingredients that are more effective in higher concentrations called a Self-Nano Emulsifying Drug Delivery System (SNEDDS).

The treatment includes anti-inflammatory agents Boswellia Serrata and Curcumin and the supporting ingredient Artemisinin that all have immuno-modulatory properties.

The clinical trial will provide additional data to verify claims on the treatment as an investigational medicinal product and facilitate the gathering of essential data required to register the anti-inflammatory treatment as a drug.

Trial results set for publication in October

Phase III of the clinical trial for the treatment for COVID-19 will begin this week and is scheduled for completion in September, with the results expected to be available in October.

Regulatory approvals for the Phase III clinical trial for the anti-inflammatory medicine are currently being sought from medical authorities in Brazil and Israel.

MGC Pharma has the required permits and approvals in place so that the company is ready to start production of its cannabinoid medicine for COVID-19 as an investigational medicinal product.

The biopharma company has a development program for the medicine to support pre-clinical and clinical trials for additional inflammatory and autoimmune indications.