Approval from the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS Health Research Authority enables the company to initiate the ENDOCAN Phase II study evaluating MRX1 CBD oral solution.
The double-blind, placebo-controlled pilot trial will assess the therapy’s safety and efficacy in reducing pain and improving quality of life for women with endometriosis.
The study will randomise up to 100 women diagnosed with endometriosis to receive treatment during a 12-week period.
It will be conducted through NHS Lothian and NHS Grampian in Scotland.
The trial is led by principal investigator Lucy Whitaker, working alongside endometriosis specialists Andrew Horne and Phillipa Saunders at the University of Edinburgh.
The research is being funded by Scotland’s Chief Scientist Office.
Endometriosis is a chronic inflammatory condition affecting an estimated 190 million women globally.
It occurs when tissue similar to the uterine lining grows outside the uterus, often within the pelvic cavity, leading to chronic pain and reduced quality of life.
In the UK, the condition is estimated to cost around £8.2bn annually through healthcare costs and lost productivity.
Current treatment options include surgical removal of lesions, hormone-suppressing drugs, analgesics and antidepressants.
However, many treatments are associated with limited effectiveness and significant side-effects, and symptoms recur in around 40–50% of patients within 5 years of surgery.
As a result, there remains a significant unmet need for new therapeutic options.
The ENDOCAN study will evaluate MRX1 CBD oral solution at doses up to 12.5 mg/kg/day. For a 70 kg patient, this equates to approximately 875 mg per day, substantially higher than typical consumer CBD intake recommendations.
The investigational formulation is designed to be effectively THC-free, allowing higher dosing without concerns about intoxication.
The approvals from MHRA and the HRA represent an important regulatory milestone for the programme, enabling site initiation and patient recruitment to begin.
Commenting on the development, Melissa Sturgess, CEO of Ananda Pharma, said the company aims to address the significant personal and societal burden associated with endometriosis by developing a standardised, clinically validated CBD therapy that could potentially be prescribed within specialist women’s healthcare pathways.
Further updates on trial progress are expected as recruitment begins.