ObsEva SA drug linzagolix helped reduce pain associated with a disorder in the tissues of the uterus in a mid-stage clinical trial.
The trial, named Edelweiss, evaluated four different doses of the drug in 327 women with moderate-to-severe endometriosis-associated pain. Endometriosis is a disorder in which tissue that normally lines the inside of the uterus — the endometrium — grows outside the uterus.
Results from the trial showed that 61.5% of the 114 patients on the 75-milligram dose saw a reduction of at least 30% in combined menstrual and non-menstrual pelvic pain, compared to 49.4% of the 49 patients on the 50mg dose, 56.4% of the 51 patients on the 100mg dose 56.3% of the people on the 200mg dose, and 34.5% of the patients on placebo.
In addition, patients across all dose ranges of linzagolix saw a greater reduction in menstrual and non-menstrual pain versus placebo.
ObsEva said 24-week data, including the bone mineral density assessment, is expected to be available in the fourth quarter. The company subsequently intends to seek feedback from regulatory authorities on the design of a phase 3 clinical trial program by the end of 2018.
Switzerland-based ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy.