Ananda Developments plc announced that 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. These trials, involving up to 500 patients, will be conducted by investigators at University College London and Great Ormond Street Hospital.
The trials aim to assess the safety and efficacy of Ananda's cannabidiol (CBD) and CBD plus tetrahydrocannabinol (THC) formulations in patients with treatment-resistant epilepsy. The studies will include children and adults with complex epilepsies, with one trial focusing on refractory early-onset epilepsies and the other on refractory genetic generalized epilepsies in patients with normal cognitive ability.
Trial Design and Objectives
The randomized controlled trials will compare MRX2 (CBD) and MRX2T (CBD + THC) against a placebo. The primary objective is to determine if these medicines are safe and effective in reducing the frequency and severity of seizures. Secondary endpoints include assessing the impact on learning, sleep, behavior, quality of life, stress, and anxiety.
Professor Finbar O'Callaghan and Professor Helen Cross of University College London (UCL) and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) will co-lead the trials. Patients will be recruited from multiple NHS sites across the UK and will receive the assigned treatment for 24 weeks.
Significance of the Research
These trials are the first double-blind randomized controlled trials to investigate the combined use of CBD and THC for epilepsy and the first to evaluate these medicines in a broad range of difficult-to-treat epilepsies in both children and adults. Previous studies have focused on CBD-only treatments for rare, drug-resistant epilepsy conditions such as Dravet Syndrome, Lennox Gastaut Syndrome, and tuberous sclerosis complex.
Melissa Sturgess, CEO of Ananda, 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."
Economic Context
NICE estimates that the combined direct and indirect costs of epilepsy to the NHS are £2 billion per annum, with the majority of these costs associated with patients who have refractory epilepsy. Successful trials could pave the way for regulatory approval and NHS availability, potentially reducing this economic burden.
