By Sara Miller, NoCamels -
Endometriosis is one of the most pernicious diseases affecting women – for many causing severe pain, depression and even infertility – and it currently has no cure.
The disease is caused when tissue similar to that making up the lining of a woman’s uterus (the endometrium) grows in other areas, mainly in the pelvic region but occasionally also in other parts of the body.
Endometrium tissue normally breaks down and leaves a woman’s body during her period. But if the tissue moves to a different part of the body, it has no way of being expelled and instead can cause permanent internal scarring. It can also be extremely painful during menstruation or even when going to the bathroom or having sexual intercourse.
The World Health Organization says that while it affects 1 in 10 women on the planet, treatments to alleviate the symptoms of endometriosis, such as medication or surgery, are not always effective and not always available to all sufferers due to location or socio-economic circumstances.
But now Israeli femtech startup Gynica believes that it has a permanent solution to this devastating disease – cannabinoids, the main component in the cannabis plant.
“[Endometriosis] is a disease that doesn’t have a cure,” Dr. Sari Prutchi-Sagiv, Gynica’s chief scientific officer, tells NoCamels. “There’s nothing out there and women really suffer.”
Some women have even had a hysterectomy in an effort to ease the pain caused by endometrium tissue migrating to other areas of their reproductive system.
Research has shown that endocannabinoids – cannabis-like molecules found naturally in the body – play a great role in the female reproductive system. In fact, when a woman is pregnant or on her period, the female reproductive system has the most endocannabinoids of any part of the body.
Harvard Medical School called the human endocannabinoid system “critical for almost every aspect of our moment-to-moment functioning,” controlling crucial functions such as sleep, learning, immune responses and even eating.
The importance of endocannabinoids first led Gynica to research cannabinoid-based therapies for women’s health issues.
The privately funded company decided to focus on a treatment for endometriosis due to its common occurrence and extremely debilitating nature, Prutchi-Sagiv says.
“Endometriosis is a very inflammatory disease because there’s a lot of macrophages in the reproductive system, which really cause a lot of pain, a lot of inflammation,” she explains, referring to a form of white blood cell found in the immune system that kills pathogens such as bacteria, viruses and even cancer cells.
Cannabinoids, however, are known for their anti-inflammatory properties, and the company spent four years studying varying combinations of cannabinoids and macrophages to see the impact of the former on the latter.
“We started using fractions and then isolates of these cannabinoids, trying to find the best solution for this problem,” Prutchi-Sagiv says.
“We were working a lot with in vitro testing in order to see which are the best cannabinoids – which are the safe ones, which are the ones that we can use intravaginally, what would be the best formulation.”
Not only do the cannabinoids reduce inflammation but they also deter the movement of the endometrium cells to different parts of the body. These two outcomes, together with the analgesic properties of cannabinoids, make the cannabinoid therapy a three-fold treatment that tackles different aspects of endometriosis.
This led the researchers to create two different cannabinoid compounds – S-301 and S-302 – for which the company last month announced it will begin clinical trials in the near future.
The treatments are administered using Gynia’s proprietary slow-release suppository, IntraVag, which was developed specifically for this therapy.
The company is actually the first in the world to conduct clinical studies using cannabinoids as a treatment for endometriosis. There are existing treatments available using CBD, a non-psychoactive cannabinoid found in cannabis plants, but Prutchi-Sagiv points out that they have not been clinically tested.
The phase 1 trial for each compound will initially comprise 12 women, over a period of 14 days. If these phase 1 outcomes are as successful as hoped, the company will at once progress to phase 2 studies, a large trial involving more patients for some three months, with a month-long observation period immediately afterwards.
The clinical trials will be conducted at Careggi University Hospital in Florence, which is the base of Prof. Felice Petraglia, the former president and co-founder of the Society for Endometriosis and Uterine Disorders (SEUD).
Prutchi-Sagiv is extremely optimistic that the upcoming trials will prove that Gynica has created an effective cure for a disease that has caused misery and pain for tens of millions of women.
“I really, really believe in cannabinoids,” she says. “Let me tell you, they really work.”
