Are we witnessing a revolution in the treatment of endometriosis?

March marks Endometriosis Awareness Month, an opportunity to raise awareness, demand change, and show support for the 200 million women of reproductive age affected by the condition globally.

The symptoms of endometriosis can begin in early adolescence and include pelvic pain, painful periods, painful bowel movements, excessive bleeding and, in some cases, infertility.

Currently, there is no cure for it. The most common treatment options are conventional painkillers and hormonal contraceptives.

Though there is no clinical evidence of the efficacy of birth control pills for endometriosis, superficial improvements in symptoms such as dysmenorrhea have prompted healthcare providers to offer them as the first line of treatment.

“One of the first things doctors do is give women the contraceptive pill,” says Paula Keusch, vice president of business development at Gynica Healthcare, an Israeli biotech company developing cannabinoid-based solutions for endometriosis.

“However, the birth control pill is not an ibuprofen. It’s not an aspirin. These are hormones and no one should automatically be given the pill.”

Previous research on the use of illicit cannabis in women with endometriosis has shown promise.

“The endocannabinoid system – a widespread neuromodulatory system that plays important roles in the central nervous system – is crucial in many functions, including body homeostasis, immune system and reproductive functions,” explains Dr Sari Prutchi Sagiv, Gynica VP of research and development.

“The female reproductive tract is full of this endocannabinoid system. The thing with endometriosis is that there is an association between a low function of this endocannabinoid system and endometriosis development and maintenance. So this makes it a very good target for external cannabinoids.

“Inflammation is a mechanism that triggers endometriosis. There are a lot of agents called pro-inflammatory agents, also known as cytokines, which make the condition worse. On the other hand, many cannabinoids are known for their anti-inflammatory action and can act as good pain relievers.”

In some countries, women have already tried cannabis-based products to treat their symptoms. However, none of the companies commercialising these products seem to have any clinical or preclinical validation.

“Based on a regulatory loophole, all the companies in this sector have brought to market products with no safety validation, no efficacy validation and no standard of care that is expected from a medical product,” says Yotam Hod, co-founder and CEO of Gynica.

“They provide the much needed relief women are looking for, but not a single one of them is validated with preclinical or clinical studies. With Gynica, we’re doing the reverse engineering.

“We are researching the best ingredients, the best concentrations and the ratio of specific ingredients alongside a proprietary intra-vaginal drug delivery method to help us provide an end product that would allow to control the release of those ingredients and help us reach the target organs.”

Gynica is the global first company to run clinical studies using cannabinoids specifically for gynaecological conditions in compliance with pharmaceutical standards and protocols.

But gathering clinical evidence requires a very rigorous process. Clinical studies can take years to be approved and the stigma around medical cannabis does not help.

“Cannabis does come with a lot of stigmas and taboos,” says Hod.

“However, according to pharmaceutical standards, examining the safety and efficacy of cannabinoids and coming up with clinically validated products will help us reduce some of that stigma and empower health professionals.”

“The awareness around endometriosis has allowed women to open up about their excruciating pain, but doctors don’t have a clinically validated medication they can prescribe,” adds Keusch.

“So when these women come across cannabis-based products, they simply want to get that much needed relief without thinking about the risks. But the risks exist.

“Our aim at Gynica is to go through all the necessary clinical trials that would allow us to come up with a safe, pharmaceutical solution.

“Yes, the process is slow and frustrating at times, but in order to get to the best and safest end product possible, we need to follow all the necessary steps,” she continues.

“With the help of our colleagues from this space, who are working on early diagnosis solutions, we can change the way we diagnose and treat this condition.”

The coming 18 months are exciting for Gynica. The start-up will enter its clinical phase and will run two clinical studies – phase one for examining safety and toxicity and phase two for examining product efficacy.

“The clinical phase is the most significant milestone we’ve been waiting for,” says Hod.

“These are our biggest steps forward and I think they will put us in a whole different position.”

The team is also hoping to explore other women’s health conditions.

“We have gained a lot of experience in the past few years when it comes to product development for gynaecological conditions, and we want to explore this space more.

“We can’t talk that much about it, but we’re not stopping at endometriosis.”

“We’re on the right path, but we just need a little bit more time,” adds Keusch.

To find out more, visit gynica.com.