Endometriosis Awareness Month 2021: 300% increase in endometriosis clinical trials

GlobalData Healthcare 26th March 2021 (Last Updated March 26th, 2021 09:45)

March is Endometriosis Awareness Month, in which education and fundraising events take place across the world with the aim of increasing awareness of this common chronic disease.

Endometriosis Awareness Month 2021: 300% increase in endometriosis clinical trials
March is Endometriosis Awareness Month. Credit: Michail Petrov / Shutterstock.

March is Endometriosis Awareness Month, in which education and fundraising events take place across the world with the aim of increasing awareness of this common chronic disease.

Raising awareness and understanding of endometriosis is essential in order to encourage more women to seek medical help for this underdiagnosed condition and to improve practices for diagnosing and treating patients.

This year, Endometriosis Awareness Month is being celebrated with a series of remote events. These include VirtualEndo24, a virtual medical conference organised by the International Society of Gynecological Endocrinology that provides a platform for more than 120 speakers, an online social event hosted by the social network and support group MyEndometriosisTeam and the Endometriosis Foundation of America’s ‘March into Awareness’ video challenge, which invites patients to share a video of themselves answering the prompt “Tell me you have endometriosis without telling me you have endometriosis.”

Endometriosis Awareness Month shines a spotlight on common endometriosis symptoms and highlights the debilitating impact of endometriosis on those living with the disease. Often associated with pain and infertility, endometriosis is characterised by the growth of endometrial tissue (tissue lining the uterus) in ectopic locations such as the ovaries and fallopian tubes. It is a highly prevalent condition among reproductive-age women. GlobalData estimates that there were over 9.5 million diagnosed prevalent cases of endometriosis among females ages 12 to 54 years across the 7MM (seven major markets, namely the US, France, Germany, Italy, Spain, the UK, and Japan) in 2020 based on primary research interviews with key opinion leaders (KOLs), as well as secondary research. However, the diagnosis of endometriosis is challenging and diagnostic delays are common, meaning that many more women are thought to suffer undiagnosed.

In addition to low diagnosis and treatment rates, clinical unmet needs remain for safer and more efficacious therapies. Hormonal therapies, which prevent the growth of endometriotic lesions, represent the mainstay of treatment, although these therapies are inappropriate for women who wish to conceive due to their disruptive effects on the menstrual cycle. In addition, hormonal therapies are often associated with side effects. For example, gonadotropin-releasing hormone (GnRH) agonists can induce loss of bone mineral density. However, in recent years, the emergence of oral GnRH antagonists has begun to address an unmet need for more convenient administration. AbbVie’s Orilissa was approved in the US and Canada in 2018 while ObsEva’s linzagolix and Myovant Sciences’ relugolix are both in late-stage development.

Considering the high prevalence and level of unmet need, research and development (R&D) activity in this area is moderate, with 121 endometriosis trials initiated between January 2010 and December 2019, according to GlobalData’s Pharma Intelligence Center’s clinical trials database (includes Phase I, I/II, II, II/III and III clinical trials, including ongoing, completed, terminated, and withdrawn trials and excludes clinical trials sponsored by government bodies and institutions such as universities, hospitals, and non-profit institutes, as reflected on the PIC on March 18, 2021). Bayer, Ferring International and AbbVie were among the most highly active sponsors with 21, 11 and seven trials, respectively.

However, in recent years the clinical trials landscape has diversified, with more companies entering this space. While only three companies initiated endometriosis clinical trials in 2010, 12 companies conducted endometriosis trials in 2019, an increase of 300% over this ten-year period. This is highlighted in the following figure, which shows the number of companies conducting endometriosis clinical trials each year from 2010 to 2019.

The endometriosis market is increasingly becoming more attractive to drug developers, as understanding and awareness of the disease increases. This is an encouraging shift, as it increases the potential for the development of alternative therapies with novel mechanisms of action. For example, Immunitor, which specialises in the development of vaccines for infectious diseases, has recently entered the endometriosis space. The company is developing V-Endo, an orally administered therapeutic vaccine currently in Phase II development, which is thought to provide therapeutic benefit by promoting immune tolerance and dampening inflammation.