Organnon stops working on endometriosis medication after failure in the phase 2 test

An experimental organnon medication to relieve the pain caused by endometriosis has not achieved the main objective of a mid-term clinical trial, bringing the company to interrupt the development of this product candidate, previously described as a key element of his growth strategy.

The announcement of Tuesday of Organon offered few details on the results of the trial, which scored 354 women aged 18 to 49 who felt moderate to severe pain linked to endometriosis. The main objective of phase 2A / B study was to measure the change in the overall pelvic pain score after 16 weeks. Jersey City, Organon, based in New Jersey, only said that his medication, OG-6219, did not beat placebo, as evaluated by a digital scale used to measure pelvic pain.

In endometriosis, the uterine mucosa grows outside the uterus, causing abdominal pain. The standard treatment of this chronic condition includes over-the-counter pain relievers, such as non-steroidal anti-inflammatory drugs. Since hormone changes can worsen endometriosis pain, drugs that limit or stop hormones offer another choice of treatment. But hormone therapy is accompanied by risks of side effect. For serious or advanced cases of endometriosis, surgery is another treatment option.

“As there are currently limited treatment options for women with endometriosis, this represents a priority disease area for us,” said Organon in his annual report.

With OG-6219, a pill twice a day, Organon hoped to introduce a new non-hormonal option for the treatment of pain in endometriosis. The drug is a small molecule designed to inhibit the hydroxysteroid 17-Bêta Dehydrogenase type 1 (HSD17B1), an enzyme that plays a role in the regulation of the growth of uterine fabric. This approach aimed to offer a targeted local effect on the tissues of endometriosis without affecting hormones that circulate systemically.

During a conference call in February to discuss the financial results of 2024, the chief of research and development and the chief doctor Juan Camilo Arjilona Ferreira said that Organon has a safeguard program at OG-6219, “which supports our objective of delivering a product based on this new mechanism.” Tuesday’s announcement did not discuss the status or plans of the backup program.

Organon came out of Merck in 2021 as an autonomous company and listed on the stock market with a portfolio composed of the former women’s health company of the pharmaceutical giant and non -patient medicines. Although these products provide regular income, Organon also aimed to acquire and develop new drugs that offer an opportunity for growth.

The Merck spin-off did not come with a lot of drug discovery staff and infrastructure. Organon turned to business development as a means of building a pipeline of candidates for various stages of development. The OG-6219 was part of the acquisition in 2021 of its developer, the female health company Forendo Pharma. Organon paid $ 75 million in advance and assumed $ 9 million in biotechnology debt. Additional $ 600 million was linked to the realization of the milestones.

Forendo has also brought another HSD17B1 inhibitor to Organon, now named OG-7191 of the code. This preclinical drug is developed as a treatment of polycystic ovarian syndrome (SOPK), a chronic disease that causes disruption and infertility of the menstrual cycle. There is currently no therapy approved by the FDA for the SOPK, making it another priority disease area for Organon, said the company in its annual report.

Organon’s growth strategy goes beyond women’s health. Last year, the company paid $ 175 million in advance to acquire Dermadent, a king’s science subsidiary whose main active is Vtama, a topical drug with FDA approvals in plaque psoriasis and atopic dermatitis.

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