World-first at NNUH with endometriosis drug trial

A world-first has taken place at our hospital with the start of new non-hormonal drug trial that will investigate whether it can reverse the debilitating symptoms of endometriosis and reduce the need for surgery.

The chronic condition affects 1 in 10 women in the UK and occurs when cells similar to those lining the womb are found elsewhere in the body and can cause painful symptoms including heavy periods, pelvic pain and in extreme cases scarring and damage to the pelvic organs.

The Gynaecology and Research and Development team at NNUH are playing a key role in leading a Phase II research study, which will evaluate an antibody designed to reduce inflammation and endometriosis symptoms.

The first patient has taken part in the AMY109EU (ACERS; Assessing a new treatment Concept for EndometRioSis) study which is trialling the safety and effectiveness of an antibody called AMY109, which 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.

Edward Morris, Consultant Gynaecologist and NHS East of England Medical Director is UK Chief Investigator on the study. He said: “Patients with endometriosis have inflammation, which is a key component in disease progression and if it goes on long enough it damages tissues.”

“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.”

Other hospitals in the UK are also taking part in this study and potential participants may be able to take part in the randomised study if they:

– Are female aged 18-49

– Have endometriosis previously diagnosed by laparoscopy (incision made in the abdomen and a thin tube with a camera (laparoscope) inserted to look for lesions, adhesions and endometrioma (cyst/s)).

– Willing to have laparoscopic surgery after study treatment.

Paul Simpson, Consultant Gynaecologist, who is the Principal Investigator at NNUH, added: “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.”

Phase I trials of the antibody have involved healthy volunteers and patients in Japan and Taiwan.

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.

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.”

For more information, email gynae.research@nnuh.nhs.uk