ObsEva's linzagolix meets in Phase IIb for endometriosis-associated pain

ObsEva S.A. (NASDAQ:OBSV) said three of four doses of linzagolix (OBE2109, KLH-2109) met the primary endpoint in the Phase IIb EDELWEISS trial to treat moderate to severe endometriosis-associated pain. The company plans to present additional data from the trial in 4Q18 and start Phase III testing in the indication by year end.

In the double-blind, international, 327-patient trial, once-daily oral linzagolix for up to 12 weeks led to response rates of 61.5% at the 75 mg dose (p=0.003), 56.4% at the 100 mg dose (p=0.039) and 56.3% at the 200 mg dose (p=0.034) vs. 34.5% for placebo. The once-daily 50 mg dose of linzagolix led to a response rate of 49.4% (p=0.155). Response was defined as a reduction of at least 30% in combined menstrual and non-menstrual pelvic pain over the last 28 days of treatment on a verbal rating scale...