ObsEva announces that nolasiban Implant 4 study did not meet primary endpoint in women undergoing embryo transfer.

ObsEva SA announced that the Phase III clinical trial results from its European confirmatory study of nolasiban (IMPLANT 4) in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF) did not meet the primary endpoint of an increase in ongoing pregnancy rate at 10 weeks, (39.1 % placebo vs 40.5 % nolasiban) (p = 0.745). Nolasiban was well tolerated. All subjects will continue to be followed up to delivery and infant development will be assessed up to 6 months.

IMPLANT4 is a randomized, double blind, placebo controlled clinical trial that included 807 patients from more than 40 fertility clinics across nine European countries. Women undergoing a Day 5 transfer of a single, fresh embryo were randomized to receive either a single 900 mg dose of nolasiban or placebo (1:1) 4 hours prior to ET.The primary endpoint of the trial was ongoing pregnancy as determined by ultrasound at 10 weeks following ET.

" We are extremely disappointed with these unexpected results, not in the least for the millions of women hoping to have a baby through IVF. I would like to acknowledge the excellent execution of the study by our employees, and to thank our investigators as well as the women who participated in our trials,� said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva. �Based on these results, we have decided to discontinue the current nolasiban IVF program and will explore potential repositioning of the product candidate.