UK hospital launches ‘world-first’ endometriosis study

A UK hospital has launched a “world-first” endometriosis drug trial that could pave the way for new ways to manage and treat the condition.

The study, taking place at the Norfolk and Norwich University Hospital (NNUH), consists of a non-hormonal drug trial that will investigate whether it could reverse the debilitating symptoms of endometriosis and reduce the need for surgery.

Endometriosis affects one in 10 women in the UK and occurs when cells similar to those lining the womb are found elsewhere in the body. It can cause painful symptoms, including heavy periods, pelvic pain and in extreme cases scarring and damage to the pelvic organs.

Currently, there is no cure for endometriosis. Medications to reduce the severity of the symptoms range from pain relief drugs to hormonal treatments that suppress ovulation and periods.

As part of a Phase II research study, the gynaecology and research and development team at NNUH aim to evaluate the safety and effectiveness of an antibody designed to reduce inflammation and endometriosis symptoms.

The antibody, called AMY109, has been developed by scientists from Chugai Pharmaceutical Co Ltd. The drug blocks a protein (interleukin-8) which promotes the body’s inflammatory response to endometriosis.

“Patients with endometriosis have inflammation, which is a key component in disease progression and if it goes on long enough it damages tissues,” said Edward Morris, consultant gynaecologist, NHS East of England medical director and UK chief investigator on the study.

“Significant new drugs for endometriosis have not come along for decades and the ones we have in daily usage are largely hormone based, which can have unpleasant side effects.

“The way that AMY109 works in reducing inflammation and potentially the destructive scarring of endometriosis could mean in the long-term that some women may avoid surgery for this debilitating disease.

“Whilst this is the first detailed study of a drug such as this on endometriosis, it is still early days and is likely to take several years from the realisation of a drug to it becoming readily available.”

Paul Simpson, consultant gynaecologist and principal investigator at NNUH, said: “Everything so far in the treatment of endometriosis has suppressed the disease symptoms, but this new drug addresses inflammation and potentially reverse the effects of endometriosis without the need for surgery.

“It is different to every other available treatment for endometriosis because it could be disease modifying. Antibody based treatments are widely used in healthcare for treating some cancers and chronic inflammatory conditions such as, rheumatoid arthritis and inflammatory bowel disease.”

Emma Cox, CEO of Endometriosis UK, said: “The need for more investment in research into endometriosis cannot be overstated. Left untreated, endometriosis may progress. Yet current options are limited to surgery, hormonal management, or pain killers for the chronic and often severe pelvic pain that is a symptom of the disease.

“Whilst this potential new drug is at an early stage in its development, the researchers hope it will not only reduce inflammation caused by endometriosis but may potentially reduce scarring that has already occurred. With the added benefit of being non-hormonal it could be also available to those for who contraceptives are not suitable.”

She added: “Whilst it is early days in the research process, it’s great to see much needed investment in novel new ways to manage and treat endometriosis. We look forward to seeing the outcomes of this clinical trial.”

The hospital is looking for more women to get involved in the study.

Participants need to be:

• Female and aged between 18 and 49
• Have endometriosis previously diagnosed by laparoscopy
• Be prepared to have further laparoscopic surgery after the study

For more information, email [email protected].