Ananda Developments Plc (AQSE:ANA) said its cannabis-based medicines will be used in two major NHS-backed phase IIIa trials exploring treatments for drug-resistant epilepsy.
In the first study, Ananda’s MRX2 (CBD) and MRX2T (CBD+THC) medicines will be tested against a placebo in patients with drug-resistant epilepsy that begins in early childhood.
In the second evaluation, the same drugs, MRX2 and MRX2T, will be tested against a placebo in patients with drug-resistant genetic epilepsy, who have normal cognitive abilities.
In all, 500 children and adults from across the UK will be involved. Researchers at University College London and Great Ormond Street Hospital will lead the research, which aims to test whether the medicines can reduce seizures and improve participants' quality of life.
Both trials, co-funded by the NHS and National Institute for Health and Care Research, are expected to last 24 weeks, with patients receiving either one of Ananda’s treatments or a placebo.
The research will examine not only seizure control but also other factors such as learning, sleep, behaviour, and overall quality of life.
The results will help determine whether these medicines are safe and effective enough to gain approval from the Medicines and Healthcare products Regulatory Agency (MHRA) and other regulatory bodies.
"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," said Ananda CEO Melissa Sturgess.
"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."
The UK government currently spends around £2 billion annually on epilepsy treatment, with much of this cost focused on patients with treatment-resistant epilepsy. If successful, these trials could pave the way for new, more effective options for these individuals.
Ananda will supply the medicines for the trials and hopes to expand its role in the development of cannabinoid-based epilepsy treatments.