2023-11-26 12:00:45
The Sant Joan de Déu Hospital in Barcelona is participating in a clinical trial to develop the first treatment against Polycystic Ovary Syndrome (PCOS). The illness affects between 5 and 10% of women or pregnant people of fertile age and is unknown by a large part of the population, despite being the most frequent cause of female infertility.
Till the date, 98% of women who suffer from PCOS are prescribed birth control pills in order to stop the physical consequences of the pathology such as acne and excess hair, but in no case does it treat the long-term effects of this condition, such as infertility or the increased risk of suffering from cardiovascular problems, certain types of cancer. or type 2 diabetes.
The drug could hit the market in mid-2026
“Before, for many gynecologists, life, and problems, began after menstruation,” explains Dr. Lourdes Ibáñez, coordinator of the study at the Sant Joan de Déu Hospital in Barcelona. The syndrome manifests itself after menstruation, but that “does not mean that the disease arises that same day.” In fact, the syndrome can occur during the neonatal period, says the doctor.
Excess fat
The study – called SPIOMET4HEALTH, framed within the Horizon 2020 program and funded by the European Commission – focuses on the root cause of PCOS: excess fat in places where it shouldn’t be, which is called ectopic or misplaced fat. In this sense, medication redistributes this fat to be able to solve all the problems that PCOS then triggers, such as irregular menstruation, excessive body hair or acne.
Once the ectopic fat has been resolved, little by little the body returns to normal: menstruation returns because the ovary starts working again, a factor that cannot be achieved with birth control pills, since they stop working with them. In fact, The drug studied is a pro-conceptive: It aims to restore ovarian function and fertility.
European study
After a research of nearly 20 years of work and several pilot studies of small groups of patients of between 60 and 70 people, it is currently being replicated in seven hospitals in different parts of Europe to verify its operation on a large scale and with multiple variables, such as age or ethnicity.
The medicine It is made up of three drugs concentrated in a single pill. And, to test its effectiveness in the most objective way possible, all the patients participating in the study have been divided equally into four groups: one takes the tablet with one drug, the second with two, the third with three. , and the fourth with none. So that, Neither the patients nor the doctors know which group they belong to. part –only those who control the study externally have knowledge–, so “the result has more value since you do it blindly,” says Dr. Lourdes Ibáñez.
The study is being carried out in Catalonia in both Barcelona (Hospital Sant Joan de Déu) as in Girona (Institut d’Investigació Biomèdica de Girona Dr. Josep Trueta). The first hospital hopes to recruit 70 patients and the second 46. Additionally, the trial brings together a consortium of 17 key organizations and research groups working on PCOS across Europe. Research is also being carried out in Italy, Denmark, Turkey, Austria and Norway.
Go to market
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He Final drug could hit the market in mid-2026, since the inclusion period to participate in the study ends on April 30, 2024, and the duration of treatment is one year. Thus, once the study is completed, if everything continues correctly, it would take another year to be marketed.
An advantage of the future of treatment is that the European Medicines Agency (EMA) have already reviewed the study protocol and they have reached an agreement, so the first obstacle to its approval has already been overcome. “If it goes well, we will go straight, everything will be easier,” says the doctor.
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