Ananda Developments' Cannabinoid Medicines to Undergo Phase III Trials for Refractory Epilepsy
Key Insights
Ananda Developments (search)' MRX2 (search) (CBD) and MRX2T (search) (CBD + THC) will be evaluated in two Phase III trials for refractory epilepsy (search) in children and adults.
The trials, involving up to 500 patients across multiple NHS sites, represent the largest investigational trials into cannabis and refractory epilepsy (search).
The randomized controlled trials (RCTs) are designed to support potential regulatory approval for MRX2 (search) and MRX2T (search) versus placebo over 24 weeks.
Ananda Developments (search), a UK-based biotech firm, is advancing clinical cannabis research with two Phase III trials evaluating its proprietary cannabinoid medicines, MRX2 (search) (CBD) and MRX2T (search) (CBD + THC), for refractory epilepsy (search). These trials, co-funded by the National Institute for Health and Care Research (NIHR) and the NHS, aim to assess the safety and efficacy of these medicines in children and adults with refractory epilepsy.
Involving up to 500 patients across multiple NHS sites, these trials are the largest of their kind globally and the first major UK trials into this condition since GW Pharmaceuticals' research. The trials address the British Paediatric Neurology Association's (BPNA) need for more comprehensive data across a broader range of epilepsies before recommending CBD-based drugs beyond Dravet Syndrome (search) and Lennox-Gastaut Syndrome (search).
Trial Design and Objectives
The two randomized controlled trials (RCTs) are designed to support potential regulatory approval for MRX2 (search) and MRX2T (search):
- Trial 1: Evaluates MRX2 and MRX2T versus placebo in patients with refractory early-onset epilepsies.
- Trial 2: Investigates the same medicines in patients with normal cognitive abilities and refractory genetic generalized epilepsies.
Patients will be randomly assigned to receive MRX2 (search), MRX2T (search), or a placebo over 24 weeks. Ananda Developments (search) will supply these formulations, including a matched placebo.
Addressing Concerns and Regulatory Requirements
Melissa Sturgess, CEO of Ananda Developments (search), emphasized the company's approach to meet regulators' requirements, stating, "It’s about meeting regulators at their point of need, rather than debating how they should regulate the space." Regarding concerns about using CBD isolate, Sturgess clarified that these trials are not mutually exclusive with the full-spectrum approach and focus on specific strains and formulations to achieve meaningful progress.
Ananda is also conducting a Phase I clinical trial in Australia with its MRX1 compound, examining how CBD is absorbed into the bloodstream and dosed to maintain specific levels. Additionally, the University of Edinburgh is conducting two RCTs, funded with £1.55m, to explore CBD's effectiveness in treating endometriosis-associated pain (search) and chemotherapy-induced peripheral neuropathy (search).
Expanding the Potential of CBD Treatments
These trials go beyond those conducted by GW Pharmaceuticals, focusing on a broader range of epilepsies. "The goal here is to provide the necessary data to support CBD as a treatment for a broader range of epilepsies, which could significantly improve access for patients," Sturgess noted.