For the first time ever, an epilepsy treatment that is currently in the clinical trial process, and which contains THC, has been approved by the authorities in the UK for import.
MGC Pharmaceuticals has been granted a permit for the import of its phytocannabinoid-derived treatment for refractory epilepsy, CannEpil+, into the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
CannEpil+ is a biosimilar effect-identical product of CannEpil, which is a phytocannabinoid treatment for refractory (drug-resistant) epilepsy and will now be available on prescription for patients in the UK.
Epilepsy affects approximately 600,000 people in the UK, and around 50 million people worldwide, with near to 33 per cent of adults, and 20 to 25 per cent of children suffering from refractory epilepsy ,which cannot be controlled with traditional anti-seizure medication. The approval is a welcome move for patients and their families, which have been campaigning to improve access to cannabis-based medicinal products with demonstrated efficacy at treating refractory epilepsy as well as safety.
Landmark prescription approval
The medicine will initially be used to treat ten patients in the UK who suffer from refractory epilepsy and MGC Pharma will be providing it free of charge to these patients on compassionate grounds for six months. Once the patients have started their treatment, CannEpil+ will undergo an observational trial with data being entered into a Data Collection App designed to establish a central platform to monitor the safety of treatment in patients globally.
The company says it expects the results from the observational data collection programme together with CannEpil’s historical clinical safety and efficacy data, and its Phase IIb clinical trial that is currently under negotiation with a UK NHS facility, will provide specialist neurologists and general practitioners with the confidence to prescribe CannEpil and CannEpil+ to patients in urgent need of treatment.
“The approval for the import of CannEpil+ to the UK and the associated compassionate prescriptions is an important step towards our global roll out of the treatment, and our continued commitment to patients,” commented Roby Zomer, co-founder and managing director of MGC Pharma.
“Achieving MHRA approval has been an ongoing process for some time with our UK partner Elite Pharmaco, and we expect the first patients in the UK to begin treatment with CannEpil+ in the coming months.
“The development of our Data Collection App will optimise our understanding of both CannEpil, CannEpil+ and other future treatments, and ultimately provide patients with a better treatment for refractory epilepsy, and therefore improving their quality of life.
“It is also a vitally important foundation for building strong relationships with UK medical regulators and health organisations which will benefit MGC Pharma going forward, as we look to roll out further clinical trials and products in the UK.”
What do doctors and patients need to know?
With the approval, doctors can now issue a prescription for the medicine to both adults and children. The medicine is manufactured under strict EU-GMP conditions, and can currently be provided to patients in countries that allow cannabis based medicinal products – allowing the medicine to be offered to patients at an affordable price.
MGC has worked with Alta Flora to create a bespoke version of healthcare data platform, the Eva App, to enable researchers and the medical establishment to determine how plant-based therapies improve patient quality of life.
The system captures Patient Reported Outcome Measures which can be used by regulators, manufacturers and clinicians to assess the safety and efficacy of new medicines, and enables the adjustment of measurement protocols in order to meet clinical standards and incorporate other conditions and future observational trials for their treatment.
Alta Flora CEO, Gavin Sathianathan, said: “MGC Pharma have stepped up to the challenge to provide access to life-changing medicine for ten trial patients, and Alta Flora is proud to support the effort to gather data in order to demonstrate that CannEpil+ has the potential to transform the quality of life of families struggling to deal with the consequences of childhood epilepsy syndromes.”
The medicine is currently undergoing Phase IIb, double blind, placebo-controlled trials, which are set to begin in Q3 and Q4 2021 at the Schneider Hospital in Israel and within the NHS in the UK, and is pipelined for Central Market Authorisation in the next two years.
Robin Emerson COO of Elite Growth Ltd and high-profile Medical Cannabis Advocate commented: “This is a huge step forward for cannabis-based medications in the UK. As a father of a five-year-old girl I have witnessed first-hand how Jorja’s life has been transformed by the use of a Cannabis based medication that contains THC.
“With this product approval patients that have tried everything else how have a product with some level of safety and efficacy for the treatment of epilepsy that can be prescribed by their physician. With the ongoing clinical trial portfolio that MGC Pharma have developed, including a near term UK NHS based trial, we are answering the call of clinicians in the UK who are asking for safety and efficacy data.
“The CannEpil+ programme we are executing will go a long way to moving cannabis-based medications toward greater adoption and acceptance, opening up much needed access for patients in the UK.”
Study explores safety of CannEpil on driving performance
MGC Pharma has carried out a doubleblind, randomised, placebo controlled clinical study investigating the impact of its epilepsy treatment on driving performance.
MGC Pharma has stated that its epilepsy treatment – CannEpil – was found to be safe for post-driving activities.
The clinical study was designed to assess the impact of a 1mL CannEpil dose of 20:1 CBD to delta THC on driving performance, sedation and mood.
CannEpil’s formulation is designed to treat drug resistant epilepsy with this high CBD, low THC formulation, which incorporates Graft Polymer’s GraftBio self-nanoemulsifying drug delivery system.
The study, carried out by the Swinburne University of Technology under the auspices of the Medical Cannabis Research Collaboration and sponsored by Cannvalate Australia, included the use of a driving simulator, a technique used to collect data required for the drug labelling, when pre- and early clinical studies indicate that a drug may cause somnolence or impair cognition.
It assessed 31 healthy, fully licensed drivers, 15 male and 16 female aged between 21 and 58 years, and the participants consumed either CannEpil or a placebo. At 90 minutes post-treatment, the participants completed a 40 minute “highway” drive using a driving simulator which was used to assess performance outcomes of deviation of lateral position, the standard deviation of speed, and steering variability.
Mood states and sedation levels were assessed by the Bond-Lader Visual Analogue Scale and Profile of Mood States which were administered prior to and/or following the driving task.
Currently, recreational cannabis consumption is implicated in as many as 13 per cent of drivers involved in fatal road traffic accidents in Australia. However, the direct effect of medicinal cannabis use on driving performance remains unclear.
Legislative changes in Australia permit the regulated consumption of cannabinoid-based products for therapeutic purposes, but currently, there is no standard clinical or legal guidance outlining when it is safe to drive after its use, and a positive roadside saliva test for THC may lead to criminal convictions irrespective of prescribed use.
Between 300 to 400 patients have been prescribed CannEpil across Australia and the Republic of Ireland monthly over the past two years.
MGC Pharma hopes that standardised assessment of performance decrements, including the findings of this Trial, will inform policy guidelines concerning the responsible use of medicinal cannabis products.
Khiron announces opening of first Zerenia medical cannabis clinic in Brazil
The new clinic will increase patient access to medical cannabis.
European medical cannabis group, Khiron, has opened its first Zerenia medical cannabis clinic in Ipanema in Rio de Janeiro, Brazil, as it continues its expansion into the country.
As part of its expansion into a number of jurisdictions across the globe, including Germany and Spain following recent developments, Khiron has now opened its Zerenia Rio clinic.
The clinic will provide physical consultations and telehealth services, connecting patients with medical specialists trained in the ethical, safe and responsible prescription of cannabinoid-based medications.
The medications focus on the treatment of conditions such as chronic pain, neurological pathologies, palliative care, rheumatology, psychiatry, geriatrics, endocrinology, gastroenterology, gynecology, otorhinolaryngology and dermatology.
Located in Ipanema, a city with more than 12 million people, the clinic’s initial phase will have a total capacity of approximately 23,000 patient consults per year.
The clinic will be under the leadership of Dr Eduardo Faveret as medical director and will open with more than 13 doctors for both in-person and telehealth models.
Dr Faveret commented: “Brazil continues to experience exponential growth in prescribing doctors and demand for medical cannabis products by patients. Zerenia Rio, is positioned as a comprehensive and humanised pioneer in patient health service and prevention to improve the quality of life of Brazilian families.
“We have assembled a multidisciplinary medical team that covers diverse medical cannabis specialties and treatments, which makes our Zerenia Rio clinic unique in Brazil.”
Dr Faveret and the Zerenia Rio clinic will be supported by Khiron’s strategic alliances with doctors and patient associations, including CANNAB in Salvador de Bahia, and leading medical distributors such as TAIMIN in Rio de Janeiro and Sao Paulo.
Later this year, Khiron is expecting to launch additional THC medical cannabis products in the country, which will complement its current global portfolio.
CEO and director of Khiron Life Sciences, Alvaro Torres, said: “Khiron has developed a unique, successful, and sustainable model with the implementation of Zerenia in Colombia, Perú, and the United Kingdom.
“Brazil is Latin America´s largest addressable market with more than 210 million people and we believe that our Zerenia model will replicate the success we have experienced around the world.
“We have served more than 25,000 individual patients across the globe through our model, with high peer patient acquisition and retention rates. We have a fantastic team on the ground in Brazil composed of doctors, nurses, patient advocates, and administrative staff in our Zerenia™ Rio clinic that will elevate our patient-first model to new levels.
“Khiron’s Zerenia Rio clinic in Brazil will also allow us to continue to generate more patient-based evidence on the pharmacoeconomic benefits of our Khiron-branded medical cannabis products, and through this data, Khiron could eventually be able to provide insurance benefits for patients as we have done in Colombia.”
Akanda and Cansativa to supply German patients with cannabis flower
The collaboration will see patients have access to two novel cultivars.
Akanda Corp and Cansativa are collaborating to supply the German market with dried flowers from Akanda’s EU-GMP certified indoor grow facility in Sintra, Portugal.
Under the collaboration, Akanda is expected to deliver at least 1,000 kg of flower to Cansativa over the first 12 months of the agreement.
All pharmacies in Germany will be able to purchase the products through the Cansativa platform. Since the award of the Federal Institute for Drugs and Medical Devices (BfArM) in August 2020, Cansativa Group is the only company with approval for the distribution of medical cannabis from German cultivation.
Co-founder and CEO of the Cansativa Group, Benedikt Sons, commented: “We are very glad about this agreement that allows us to introduce two novel medical cannabis flowers to the German market.
“This enables patient access to an additional supplier with a new and innovative range of medical products. This exciting cooperation marks another step in improving the product diversity and security of supply on the German market.
“We look forward to a long-term relationship with Akanda, with whom we share an important part of our mission: We want to enable physicians, pharmacies, and patients by giving them access to an extensive medical product portfolio and help improve the quality of life with the help of medical cannabis.”
CEO of Akanda, Tej Virk, added: “Our prized purpose-built indoor grow facility is the only one of its kind in Portugal that can produce EU-GMP medical cannabis equivalent to the adult-use grades available in North America.
“It has both the quality and scalability to meet the growing demand for medical cannabis in fast-growing markets across the EMEA region, such as Germany.
“We are equally excited to be partnering with the Cansativa Group to bring some of our best strains to Germany through their platform. This supply agreement represents one of the largest agreements in the nascent European medical cannabis industry and is certainly Akanda’s most substantial commercial development to date, enabling new patient experience.”