MGC Pharma deal to initiate cannabis medicine clinical trials in US

MGC Pharmaceuticals has signed an agreement to supply and distribute its products to the US market with AMC Holdings, a move that will see clinical trials for its medicines initiated in the US.

EU-based biopharmaceutical company specialising in the production and development of phytocannabinoid-derived medicines, MGC Pharma, has entered into the binding three-year agreements with US-based distribution and marketing company, AMC, that will see three of its products reach the US over the initial period, including CannEpil, CogniCann and CimetrA.

The agreement will help accelerate the clinical trials process for both CannEpil and CogniCann and help provide access to the medicines to US patients.

Clinical trials

Along with leading research institutes in the US, AMC, which is seeking to expand the research and growth of phytomedicines in the country, will initiate clinical trials for the MGC Pharma products.

These include CannEpil, a phytocannabinoid derived IMP designed to treat drug resistant epilepsy with a high CBD, low THC formula, CogniCann, a formulation of phytocannabinoids that has been developed to treat the symptoms of dementia and Alzheimer’s, and CimetrA, a nano-micellar pharmaceutical synergetic composition that is being investigated in clinical trials as a treatment for addressing anti-inflammation and cytokine storms in tested COVID-19 patients.

Initiation of the US trials, which will be in addition to the ongoing trials in Israel and Australia, is subject to Global Ethics Committee approval. AMC will seek US regulatory approvals for the products, including import licenses and US Food and Drug Administration (FDA) approval, beginning with approval for CannEpil via Florida’s Early Access Scheme.

AMC’s General Counsel and President of AMC Florida, Brent Yessin, commented: “We believe that disease management of intractable conditions, like refractory epilepsy and dementia, as well as the recent spike in COVID-19 around the US, is driving healthcare providers and researchers to seek alternatives to existing drugs or protocols.

“MGC’s track record developing botanical or bio-pharmaceutical solutions as alternatives to existing medications, many of which have negative side effects affecting patients’ quality of life, made this an exciting collaboration for AMC. We look forward to introducing MGC’s products to our national medical community.”

The agreement includes a minimum US$3m of sales in the first year, subject to AMC receiving a National Clinical Trial Number (NCTN) for an MGC Pharma product by the end of September 2021, which will enable US hospitals to participate in the clinical trials for CannEpil or CogniCann.

The clinical sites in the US will be added to the global clinical trial program for CimetrA to initiate the registration process for the medicine in the US.

Read more about the agreement on Cannabis Wealth.