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ObsEva SA Announces Phase 3 IMPLANT 2 Clinical Trial Results of Nolasiban in IVF to be Presented at Annual ASRM Meeting Tuesday October 9, 2018
- Recipient of Prize Paper Award from the Society for Assisted Reproductive Technology (SART)
Geneva, Switzerland and Boston, MA - October 5, 2018- ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss 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 announced that the Phase 3 IMPLANT 2 clinical trial results will be presented at the 74th annual meeting of the American Society of Reproductive Medicine (ASRM) taking place in Denver, Colorado, October 6-10, 2018.
ObsEva is pleased to acknowledge that the presentation has been awarded the Prize Paper of the Society for Assisted Reproductive Technology (SART).
Prize Paper Session: Tuesday, October 9 10:45 am-12:00 pm Mountain Daylight Time (MDT)
11:45 am MDT: “A Placebo-controlled, Randomized, Double Blind, Phase 3 Study Assessing Ongoing Pregnancy Rates After Single Oral Administration of a Novel Oxytocin Receptor Antagonist, Nolasiban, Prior to Single Embryo Transfer”
About the IMPLANT 2 Clinical Trial
IMPLANT 2 is a Phase 3, randomized, double blind, clinical trial designed to confirm the efficacy of nolasiban to increase the chance of pregnancy and live birth in patients undergoing IVF or ICSI. Following ovarian stimulation, egg retrieval and fertilization, eligible women were randomized to receive either a single, oral dose of 900 mg nolasiban or placebo, 4 hours before Day 3 or Day 5 fresh, single embryo transfer (SET). The primary endpoint was ongoing pregnancy at 10 weeks after SET. Women with confirmed pregnancies were monitored until delivery, with a key secondary endpoint being live birth, and the infants are being followed-up for 6 months.
About Assisted Reproductive Technology (ART)
Infertility affects about 10 % of reproductive-aged couples, with more than 2 million ART treatments (mostly IVF) performed worldwide each year. Currently 59% of fresh embryo transfers are performed on Day 5 and 31% on Day 3 in the United States (CDC report, 2015 data).
While the success of ART depends on multiple factors such as embryo response, fertilization, 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 reduced blood flow to the uterus, may impair the implantation of the embryo.
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 KGaA, Darmstadt, Germany, in 2013 and retains worldwide, exclusive, commercial rights.
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 IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.
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