AFTER launching a patient registry earlier this year further signs the UK’s National Health Service is warming to cannabis medicine have emerged with news of the potential launch of a clinical trial.
Ten patients will soon make history when they begin taking CannEpil+ – a high-CBD, low-THC treatment for drug resistant epilepsy – following import approval by the UK’s Medicine and Healthcare products Regulatory Agency (MHRA).
MGC Pharmaceuticals say this will later be combined with a Phase 2b clinical trial involving at least 50, mainly young, patients that is currently under negotiation with an unnamed NHS hospital.
In a market announcement the London Stock Exchange-listed cannabis company said it hoped this will commence before the end of this year.
Despite cannabis-based medicines being available for almost three years on the NHS, the vast majority of the UK’s 3,000 to 5,000 patients secure their prescriptions through the private sector with NHS clinicians saying there is not enough evidence on their efficacy.
In order to address this issues the NHS launched the UK’s first ‘Patient Registry for Cannabis-Based Products’ which started gathering ‘real-world’ evidence in April, this year.
MGC Pharma has partnered with London-based medical cannabis distribution and clinical trial market access company Elite Pharmaco to bring CannEpil+ to the UK.
The firm – a subsidiary of Elite Growth Ltd – is a specialist in helping producers in the field of cannabis-based medications and bio-pharma products gain access and launch products into the UK market.
It is run by cannabis advocate Robin Emerson – who successfully gained the first prescription for medical cannabis in the UK three years ago for his daughter Jorja who suffers from severe epilepsy – and Liam McGreevy, who has worked in the cannabis industry for over a decade.
Huge Plus For UK
Mr Emerson said: “This is the first time that a trial has been done outside of GW’s products. It is the first for THC in children. They tried CBD before on children with the Epiliolex product, but they never tried THC on children.”
He went on to say the MRHA’s import approval for a product that is already on a clinical pathway and contains THC, as a ‘huge plus for the UK and a huge plus for patients’.
He said: “The big issue we have at the moment in the UK is regarding doctors not wanting to prescribe. Here in the UK we very much rely on Randomised Controlled Trials (RCT) and proper clinical data evidence.
“With this drug it is the first that contains THC that is gaining that evidence base that is going to be able to help give the confidence to physicians to be able to prescribe.
“We are currently negotiating a Phase 2b NHS trial on the CannaEpil+ product within the UK. It will be the first time that you will have a THC trial within the NHS on children and will be a major step forward because no matter whatever anyone’s argument, you need to prove the efficacy of THC.
Physicians Worry About THC
“THC is the issue. THC is the one the physicians are worried about. So, if we can get a drug on the market that is able to provide safety and efficacy data around THC being used on children, then that will open the gates to other drugs and manufacturers as things move forward.”
He said the trial would focus on the under-18s as ‘that is the area of most need, where these children are having a lot of seizures, are in severe danger and whose lives are being threatened, so that is why we are centring on them, and particularly these 10 patients and families that are in the network of advocacy movement’.
One of the initial 10 patients will include a two-year-old boy from Northern Ireland who has undergone brain surgery twice but is continuing to suffer seizures.
Mr McGreevy said most of the patients had not yet tried medical cannabis.
First For The UK
The MRHA’s approval is the first-time it has permitted import an epilepsy drug containing THC and still undergoing clinical trials.
MGC Pharma providing the drug free of charge on compassionate grounds for six months It will initially be made available to 10 patients who suffer from refractory epilepsy
The patients could begin receiving the drug in as little as two weeks in a move that is a big step forward for cannabis-based medications in the UK.
Once they have started taking CannEpil+ an observational trial will get underway with information being entered into a data collection app provided by Alta Flora designed to establish a central platform to monitor the safety of treatment in patients globally.
CannEpil+ is a biosimilar effect-identical product of CannEpil, manufactured at MGC Pharma’s EU-GMP certified production facility in Slovenia, and which can be provided to patients in countries which allow cannabis-based medical products.
MGC Pharma says this allows it to offer CannEpil+ at a more affordable price to patients globally as the company moves through the clinical trial pipeline with CannEpil.
The drug is currently undergoing a Phase 2b clinical trial in Israel, where it is being tested as an add-on treatment for children and adolescents with refractory epilepsy, which occurs when anti-epilepsy medicines are no longer controlling seizures.
Epilepsy affects three million people in Europe and 600,000 in the UK. Around 87 people are diagnosed with it in the UK every day and it is one of the most common serious neurological conditions.
CannEpil is already being prescribed in Australia and was approved for use in Ireland in June this year.
If the Phase 2b trial is a success CannEpil+ will move on to Phase 3 clinical assessment comparing the safety and effectiveness of the new treatment against current standard medication.
BusinessCann approached the National Institute For Health Research for a comment on these developments – it said it is unable to comment as the proposed trial is ‘currently under negotiation’.