GENEVA, Switzerland and BOSTON, MA, USA I September 6, 2017 I ObsEva SA (NASDAQ: OBSV), a 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 reported completion of patient recruitment of its Phase 3 IMPLANT2 clinical trial of nolasiban (OBE001), an oral oxytocin receptor antagonist being developed with the goal of improving pregnancy and live birth rates following in vitro fertilization (IVF).

More than 1000 patients from fertility clinics across 9 European countries have been recruited, targeting randomization of at least 760 patients. IMPLANT2 enrollment has proceeded significantly ahead of plan, and initial results are now expected in the first quarter of 2018.

“We are very pleased to have completed recruitment for the IMPLANT2 study in only 6 months, significantly ahead of our original schedule, which we believe reflects the strong interest among both physicians and patients in improving fertility and pregnancy rates beyond currently available technologies.” said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva.

About the IMPLANT2 Clinical Trial

IMPLANT2 is a Phase 3, randomized, double blind clinical trial assessing nolasiban compared to placebo on enhancing the rate of pregnancy in patients undergoing assisted reproduction by IVF or intracytoplasmic sperm injection (ICSI) due to low fertility. Following ovarian stimulation, egg retrieval and fertilization, eligible women are randomized to receive either a single oral dose of 900 mg nolasiban or placebo a few hours before Day 3 or Day 5 fresh embryo transfer (ET). The primary endpoint is ongoing pregnancy at 10 weeks after ET. Women with confirmed pregnancies will be monitored until live birth and the infants will be monitored for one to six months following birth.

About Assisted Reproductive Technology (ART)

Infertility affects about 10 percent of reproductive-aged couples, with approximately 1.6 million ART treatments (including IVF and ICSI) performed worldwide each year.

While the success of ART depends on multiple factors such as embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and blood flow to the uterus, may impair the implantation of the embryo.

About Nolasiban

Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART. ObsEva licensed nolasiban from Merck-Serono in 2013 and retains worldwide commercial rights.

About ObsEva

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. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol “OBSV”. For more information, please visit www.ObsEva.com.

SOURCE: ObsEva