Ananda cannabinoid medicines to be used in NHS epilepsy trials
Ananda Developments plc (AQSE: ANA) is pleased to announce that two of its patent pending cannabinoid medicines, MRX2 and MRX2T, will be used in two National Institute for Health and Care Research (NIHR) and NHS co-funded Phase IIIa epilepsy clinical trials involving up to 500 patients in total. The trials will be run by investigators at University College London and Great Ormond Street Hospital.
The objective of the trials test the safety and efficacy of Ananda’s specific cannabidiol (CBD) and CBD plus tetrahydrocannabinol (THC) formulations for two treatment-resistant epilepsy groups in children and adults. If the results are favourable, they will pave the way for a submission of these medicines to the MHRA and other regulatory bodies for regulatory approval.
The trials are being funded by a partnership between NHS England and National Institute for Health and Care Research (NIHR) and will be co-led by Professor Finbar O’Callaghan and Professor Helen Cross of University College London (UCL) and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH).
Researchers will study whether these medicines are safe and effective in reducing the number and severity of seizures experienced by individuals, as well as whether they affect learning, sleep, behaviour, quality of life, stress, and anxiety.
These will be the world’s first double blind randomised controlled trials to investigate the use of CBD and THC together for epilepsy, and the first to evaluate the medicines in children and adults who have a broad range of difficult-to-treat epilepsies. Previously, double blind randomised controlled trials investigated the use of CBD-only in three rare conditions associated with drug-resistant epilepsy (Dravet Syndrome, Lennox Gastaut Syndrome, and tuberous sclerosis complex).
500 patients will be recruited across the UK at multiple NHS sites. The patients will be randomly assigned either CBD, a combination of CBD and THC, or a matched placebo manufactured to the specifications of Ananda Developments plc’s formulations, which patients will take for 24 weeks. The formulations being used for the trials are Ananda’s patent pending MRX2 (CBD) Oral Solution, MRX2T (CBD + THC) Oral Solution, and a matched placebo. The scale and design of the Phase IIIa trials will provide a greater understanding of both the benefits and potential risks of MRX2 and MRX2T as new treatments.
NICE has estimated that the combined direct and indirect costs of epilepsy to the NHS are £2 billion per annum and most of this is spent on patients with refractory epilepsy.
Ananda’s CEO, Melissa Sturgess commented:
The UK Government and the NHS have made it clear they need to see randomised controlled trials in a broad range of seizure types and epilepsies to enable wide prescribing of CBD- and THC-based medicines. We are proud that our MRX2 and MRX2T products meet the rigorous requirements for these trials and have received the support of internationally respected clinician investigators with expertise in refractory epilepsies. Our clear objective is to deliver licensed CBD-based medicines which will be available on the NHS.
