ObsEva Phase 2b trial shows sustained efficacy, safety, for endometriosis pain

– Linzagolix overall efficacy and safety maintained or improved at week 24

– Linzagolix 75mg once daily showed no clinically significant impact on Bone Mineral Density (BMD), supporting further development with no need for add back therapy (ABT)

– Linzagolix 200mg once daily results support further development with low dose add back therapy (ABT)

– Initiation of Phase 3 endometriosis trials expected in early 2019

ObsEva SA , a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced additional positive results from the EDELWEISS clinical trial of its oral GnRH receptor antagonist, linzagolix, for the treatment of endometriosis-associated pain.

In the EDELWEISS trial, hallmark pain symptoms of endometriosis, dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP), showed sustained reduction or further improvement after 24 weeks of treatment, as compared to the positive 12-week results that were announced in June 2018. Sustained efficacy was also seen in additional endpoints such as dyspareunia and dyschezia, as well as in the assessments of patient well-being, most notably the Patient Global Impression of Change (PGIC) and Endometriosis Health Profile-30 (EHP-30) questionnaire.

The main pain efficacy endpoints of the EDELWEISS clinical trial were reported as a responder analysis, with responses defined as a reduction of at least 30% in pain, recorded daily via electronic diary using a verbal rating scale (VRS) of 0 (no pain) through 3 (severe pain).

“We are very pleased with these favorable results that further demonstrate the differentiated therapeutic potential of linzagolix for alleviating the severe, painful and chronic symptoms of endometriosis. These data strongly validate ObsEva’s development strategy for linzagolix as a potential best in class oral GnRH antagonist,” said Dr. Loumaye, co-founder and Chief Executive Officer of ObsEva.

https://www.marketwatch.com/press-release/final-results-of-obseva-sa-phase-2b-edelweiss-trial-of-linzagolix-show-sustained-efficacy-and-bone-mineral-density-safety-for-the-treatment-of-endometriosis-associated-pain-2018-09-28