ObsEva Unveils Additional Efficacy Results for Linzagolix In Endometriosis-Associated Pain

ObsEva SA OBSV has announced additional efficacy results from the Phase 3 EDELWEISS 3 trial of linzagolix for moderate-to-severe endometriosis-associated pain (EAP). The results build upon the positive topline results announced in January 2022.
Two dose regimens were tested, a 200 mg once-daily dose of linzagolix combined with hormonal add-back therapy (ABT) and a 75 mg dose of linzagolix without ABT.
Both dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP) showed rapid reductions compared to placebo (after 1 and 2 months of treatment, respectively), with continued reduction up to 6 months of treatment.
Higher reductions were observed with linzagolix 200 mg + ABT compared to linzagolix 75 mg.
A similar pattern was seen for the secondary endpoints of dyschezia (painful bowel movements) and worst pelvic pain.
The reductions in endometriosis pain improved quality of life and a reduced intention for surgery after six months.
Results from the post-treatment follow-up of EDELWEISS 3 are expected in early 3Q of 2022. Results from the treatment phase of the extension study (EDELWEISS 6) and its post-treatment follow-up phase are anticipated in early 3Q of 2022 and 4Q of 2022, respectively.
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