A drug candidate Organon hailed as perhaps its “biggest potential opportunity” has flunked a phase 2 trial, prompting the company to end clinical development of the endometriosis prospect.
Women’s health specialist Organon picked up the candidate, OG-6219, in its buyout of Forendo Pharma. Seeking to build a R&D pipeline after spinning out of Merck & Co., Organon paid $75 million upfront to acquire the company in 2021 and started a phase 2 trial the next year.
Investigators randomized 354 premenopausal women with moderate to severe endometriosis-related pain to receive one of three doses of OG-6219 or placebo. Organon was betting that OG-6219 would reduce pain by inhibiting production of a hormone that regulates the growth of uterine tissue and can cause inflammation.
The bet failed. Organon found OG-6219 was no better than placebo at reducing endometriosis-related overall pelvic pain, causing the study to miss its primary endpoint. The company responded by stopping clinical development of OG-6219.
The development is a blow to Organon’s attempts to launch new growth drivers to support the approved drugs the company inherited from Merck. Talking on an earnings call in February, Juan Camilo Ferreira, M.D., head of R&D at Organon, called (PDF) OG-6219 “perhaps the biggest potential opportunity we have.”
There may still be an opportunity for Organon to generate a return on the Forendo buyout. On the February call, Ferreira said the company had a backup program for OG-6219, “which supports our goal to deliver a product based on this novel mechanism.” Organon made no mention of the backup program in its statement about the failure of the study and discontinuation of OG-6219.
Whatever happens to the backup program, the failure of OG-6219 will set back Organon’s aspirations to deliver a new nonhormonal treatment option for endometriosis. The company was planning to start a phase 3 program next year with a view to launching the product by the end of the decade.