MGC Pharma says the breakthrough in the UK will allow CannEpil to be made available to a wide cohort of specialist medical practitioners in the UK.

 European-based  biotech MGC Pharma (ASX:MXC) has made a breakthrough in the UK after its proprietary product, CannEpil, was made available in the country via the Named Patient Request.

This means that CannEpil can be prescribed by UK doctors who are listed on the General Medical Council (GMC) specialist register, which makes up a significant sub-section of the central doctors register.

There are more than 359,000 doctors on the UK full Medical Register, of which 108,000 are on the Specialist Register.

The Named Patient Request meanwhile is a regulatory pathway that allows a patient in the UK to receive a medication that is not yet licensed or available in the country, in order to treat rare or unusual conditions.

“The availability of CannEpil by Named Patient Request marks a momentous breakthrough for MGC Pharma,” said MGC CEO, Roby Zomer.

“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.”

Why the GMC Specialist Register matters

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 UK’s NHS (National Health System).

If a doctor is on the Specialist Register, it will say so as part of their status on the medical register.

Doctors can practice in a specialty not shown on their Specialist Register entry. In most cases, they must be on the Specialist Register in at least one specialty to practise as a consultant in any of the UK health services.

The GMC Specialist Register works to protect patient safety and support medical education and practice across the UK.

Big opportunity in Refractory Epilepsy

MGC’s CannEpil is currently in the process of a clinical development programme for patients suffering from Refractory (or Drug-Resistant) Epilepsy.

Refractory Epilepsy is a type of epilepsy in which seizures are not controlled with two or more appropriate antiepileptic medications (called ASMs).

Approximately 33% of adults and 20-25% of children with epilepsy have refractory epilepsy.

Epilepsy itself accounts for a significant proportion of the world’s disease burden, affecting around 50 million people worldwide.

Previous studies have shown that cannabinoids or CBD  can be effective in the reduction of seizure frequency and severity for epilepsy.

This has been supported by various open-label studies, observational studies, Randomised Clinical Trials (RCTs) and large-scale systematic reviews.

MGC Pharma’s CannEpil, a drug with an  Investigational Medicinal Product (IMP) status,  has been formulated with a high-CBD and low-THC, and is delivered to the patient via an oral mucosal solution.

The drug has been made available in Ireland since 2019 when it  received an approval from Ireland’s Health Product Regulatory Authority (HPRA).  Since then, hundreds of Irish patients have been prescribed CannEpil.

In Australia, a safety study has also shown that CannEpil was safe for post-treatment driving activities.

Data collected from patients in Ireland and Australia will be used to further evaluate the safety and efficacy of the drug, and will support future submissions for marketing authorisation.

The ‘I am Billy’ Foundation

The availability of CannEpil  via the Named Patient Request follows the announcement that MGC Pharma is providing CannEpil to an observational trial supported by the I am Billy Foundation.

The I am Billy Foundation has been 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 prescribed cannabis-based medical products (CBMPs), in addition to advancing the public understanding of the medical benefits of CBMPs.

“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,” said Zomer.

“We look forward to updating the market on the results of this trial in due course”.

This article was developed in collaboration with MGC Pharma, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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