Organon abandons endometriosis pain drug development after trial failure
The drug's failure in a proof-of-concept mid-stage study deals a blow to the company's attempt to launch a future driver of revenue, four years after it was spun off from Merck (MRK.N), opens new tab. Another drug acquired by Organon through the up to $954 million Forendo acquisition is still in lab studies.
Organon was testing the drug, OG-6219, in 354 patients aged 18 to 49 who had moderate-to-severe endometriosis-related pain, but results showed no significant improvement compared to a placebo. Improvement in pelvic pain was measured using an 11-point rating scale during the third month of treatment.
Endometriosis is a condition that affects about 190 million women of reproductive age globally, according to the World Health Organization. It occurs when tissue similar to the uterine lining grows outside the uterus, often causing chronic pelvic pain and infertility.
Organon's study was designed to assess whether the drug could meaningfully reduce pelvic pain and patients were randomly chosen to receive one of three pre-decided doses of the drug or a placebo, given orally twice a day.
Current treatments options for endometriosis include hormonal therapies such as birth control pills, progestins, and GnRH modulators such as Myfembree, co-owned by Sumitovant Biopharma and Pfizer (PFE.N), opens new tab, and AbbVie's (ABBV.N), opens new tab Orilissa.
Pain is often managed with non-steroidal and anti-inflammatory medicines such as ibuprofen and surgery remains an option for severe cases.
OG-6219 is designed to block an enzyme involved in estrogen production, aiming to reduce pain by lowering levels of estradiol at endometriosis sites without affecting hormone levels throughout the body.
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