ObsEva's nolasiban meets in Phase III to improve pregnancy rates

ObsEva S.A. (NASDAQ:OBSV) reported top-line data from the the Phase III IMPLANT2 trial in 778 women showing that a single 900 mg dose of oral nolasiban (formerly OBE001) met the primary endpoint of increasing the rate of clinical pregnancy defined as intra-uterine pregnancy with fetal heartbeat at 10 weeks post-embryo transfer vs. placebo (35.6% vs. 28.5%, p=0.031). The company is developing the oxytocin receptor (OXTR) antagonist to improve pregnancy rates in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) due to low fertility.

Following ovarian stimulation, egg retrieval and fertilization, patients received nolasiban or placebo four hours before a single embryo transfer on day three or day five after oocyte retrieval. Secondary endpoints in the the double-blind, European trial include live birth rate after 24 weeks of gestation, miscarriage rate, intra-uterine pregnancy at six weeks and positive blood pregnancy test. ObsEva plans to report live birth rate and 28-day neonatal safety data from the trial in 4Q18, with six-month infant follow-up data expected in 2019...