MGC Pharmaceuticals Ltd poised to supply global phytocannabinoid market with

() () () (FRA:H5O) is poised to supply the global phytocannabinoid-derived medicines market with its portfolio of established and upcoming products through its worldwide distribution footprint and expanding patient base. 

The European-based, vertically integrated biopharma company has a growing patient base in Australia, the UK, Brazil and Ireland and a global distribution footprint through its extensive network of commercial partners.

MGC Pharma, which has three investigational medical products (IMP) in three clinical trials, also reported a record March 2021 quarter of sales and revenue, as it delivers affordable cannabinoid medicines to patients.

Three products in clinical trials

MGC Pharma has commenced clinical trials for three of its key Phytomedicine products CannEpil®, CogniCann® and CimetrA™.

CannEpil® is designed as a treatment for refractory epilepsy.

Phase IIb clinical trial is being conducted at the Schindler Hospital in Israel on the safety and efficacy of CannEpil® as an add-on treatment in children and adolescents with refractory epilepsy.

The expected time to marketing authorisation is four years.

CogniCann® is aimed at improving dementia and Alzheimer’s disease patients’ quality of life.

Phase II clinical trial is being carried out with the University of Notre Dame in Perth to evaluate the potential behavioural benefits CogniCann® may have on patients with dementia and Alzheimer’s disease.

The expected time to marketing authorisation is five years.

CimetrA™, as a treatment to offset the Cytokine Storm and other auto-immune indications, does not contain cannabinoids and is designed from four natural ingredients as a phytomedicine to target viral infections with inflammatory complications.

In December 2020, the company completed its Phase II clinical trial at Nazareth Hospital EMMS, Hillel Yaffe Hospital in Israel and Mahatma Gandhi Mission’s Medical College & Hospital in India.

During the trial, CimetrA™ met all its primary and secondary endpoints and statistically significantly improved the clinical recovery of COVID-19 infected patients.

In March 2021, CimetrA™ received the Ethics Committee approvals from the Rambam Health Care Campus and the Nazareth Hospital EMMS in Israel for Phase III clinical trials on patients diagnosed with coronavirus.

These trials 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 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.

This Phase III trial is going through regulatory approvals for additional clinical sites in Israel and Brazil and the expected time to fast-tracked marketing authorisation is less than one year.

Preclinical R&D

The company is also developing medicines that leverage its proprietary medical cannabis formula through clinical trials in Israel, Europe and Australia.

This will enable future medical product sales across the EU, Australia and other geographies, after clearing the legal and regulatory approvals.

Its MXOT01GB01 for the treatment of Glioblastoma is in the pre-clinical stage, with Phase 1 planned in the second half of 2021.

Its InCann BiActive capsule to treat Chron’s and IBS is also in the pre-clinical stage, with Phase 1 planned for the second half of 2021.

Proprietary MGC drug delivery technology

MGC Pharma is currently conducting research development on smart nanostructured materials to deliver drugs to the target sites with reduced dosage frequency and in a controlled manner, to mitigate the side effects experienced with traditional therapies.

In particular, it is looking to resolve the main critical…