Life sciences company Ananda Developments plc (AQSE: ANA) announced on Monday that its cannabinoid medicines, MRX2 and MRX2T, will be utilised in two National Institute for Health and Care Research (NIHR) and NHS-funded Phase IIIa clinical trials focused on refractory epilepsy. These landmark studies will involve up to 500 patients and are being led by University College London and Great Ormond Street Hospital.
These trials aim to assess the safety and efficacy of MRX2 (CBD) and MRX2T (CBD + THC) against placebo in patients with drug-resistant early-onset and genetic generalised epilepsies. Should results be positive, Ananda intends to submit marketing authorisation applications for both formulations.
The trials represent the largest investigational efforts to date for cannabinoids in treating epilepsy. Current evidence suggests potential benefits of cannabis-based products for managing difficult-to-treat epilepsies, with one CBD-only medicine already licensed for specific conditions.
Ananda will supply MRX2, MRX2T and matching placebos for the trials. Recruitment will occur across multiple NHS sites, with participants randomly assigned to receive either the cannabinoids or placebo over a 24-week period. Results will contribute to a deeper understanding of both the benefits and risks associated with these cannabinoid formulations.
NICE estimates that the costs of epilepsy to the NHS exceed GBP2bn annually, primarily driven by patients with refractory conditions. Ananda's involvement in these trials underscores its commitment to developing CBD-based therapies for complex health challenges.
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