Miss on pain endpoint sinks Organon’s endometriosis candidate

Organon said it would discontinue OG-6219, one of the few non-hormonal endometriosis therapies in the clinic, after the HSD17B1 inhibitor failed to meet the primary endpoint of improvement in endometriosis-related overall pelvic pain in the Phase II ELENA trial.

With no established way of measuring lesion changes in patients, reduction in pain remains the only approval endpoint for endometriosis drugs, despite the lack of correlation between pain and disease burden, as well as the longstanding subjectivity challenges of measuring pain. None of the secondary endpoints in the study aimed to capture changes in lesion status, leaving the candidate’s effects on the disease itself unknown...