MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has achieved a major breakthrough with its proprietary product CannEpil® now available to patients in the UK by Named Patient Request.
This enables CannEpil® to be prescribed by UK clinicians who are listed on the General Medical Council (GMC) Specialist Register, a significant sub-section of the UK’s central doctors register (GMC Register).
CannEpil® products will now be supplied in order to meet the needs of individual patients where an unmet medical need exists.
Follows I am Billy trial
This breakthrough by the European-based pharmaceutical company specialising in the production and development of plant-inspired medicines follows the announcement that MGC Pharma is providing CannEpil® to an observational trial supported by the I am Billy Foundation.
“The availability of CannEpil® by Named Patient Request marks a momentous breakthrough for MGC Pharma,” MGC Pharma managing director and CEO Roby Zomer said.
“The product will now be available to a wide cohort of specialist medical practitioners in the UK, which is testament to the progress we are making,” he said.
“Material milestone”
“CannEpil’s® availability in the UK for unmet medical need by doctors on the GMC specialist register, is another material milestone for the company within the healthcare and Life-Science sector as an innovative plant-inspired pharmaceutical company.”
About CannEpil®
The CannEpil® IMP formulation is a high-CBD, low-THC formulation, delivered by oral mucosal solution, and is part of a clinical development program for patients suffering from Refractory Epilepsy (also known as Drug Resistant Epilepsy).
A safety study completed in Australia showed CannEpil® was safe for post-treatment driving activities.
In 2019, CannEpil® was made available for distribution and prescription in Ireland under full governmental health insurance coverage, making it the first product available with coverage in the Republic of Ireland under the Long Term Illness and General Medical Services schemes.
Hundreds of patients have been prescribed CannEpil® across Australia and the Republic of Ireland over the past three years.
Data collected from the patients will be used to further evaluation of the safety and efficacy of the drug and will support future submissions for marketing authorisation.
Epilepsy widespread
Epilepsy accounts for a significant proportion of the world’s disease burden, affecting around 50 million people worldwide.
The estimated proportion of the general population with active epilepsy (ie continuing seizures or with the need for treatment) at a given time is between 4 and 10 per 1,000 people.
Epilepsy is one of the most common, serious neurological conditions, with about 33% of adults, and 20-25% of children with epilepsy, suffering from Refractory Epilepsy (or Drug Resistant Epilepsy) which cannot be controlled at least two antiseizure medications (called ASMs).
CBD has been proven to be effective in the sustained reduction of seizure frequency and severity for epilepsy, which has been supported by open-label studies, observational studies, Randomised Clinical Trials (RCTs) and large-scale systematic reviews.
“Step closer to goal”
“Stepping up to the Early Patient Scheme is a significant demonstration of our Pharma footprint and is a step closer to our goal to be available to more patients in need for standardised affordable treatment,” Zomer said.
“We are extremely proud of the progress we have achieved thus far, and we are pleased that CannEpil® has been selected as a treatment within an observational patient trial in association with the I am Billy Foundation.
“We look forward to updating the market on the results of this trial in due course.”
GMC Specialist Register
The GMC Specialist Register is a list of doctors who are eligible to take up appointment in any fixed term, honorary or substantive consultant post in the NHS, although specialist registration is not a legal requirement for these posts in foundation trusts.
This register works to protect patient safety and support medical education and practice across the UK.
The GMC does this by working with doctors, employers, educators, patients and other key stakeholders in the UK's healthcare systems. There are more than 359,000 doctors on the UK full Medical Register of which 108,000 are on the Specialist Register.
About I am Billy
I am Billy is a foundation set up to aid parents and families in navigating the challenges of obtaining NHS-funded Medical Cannabis for children.
The foundation provides financial assistance in meeting the cost of cannabis-based medical products (CBMPs) prescribed by a medical consultant, in addition to advancing the public understanding of the medical benefits of CBMPs.