Geneva, Switzerland and Boston, MA –October 9, 2019- 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 the presentation of new data for its lead compounds, nolasiban and linzagolix, at the 75th American Society of Reproductive Medicine (ASRM) Scientific Congress & Expo taking place in Philadelphia (PA) from October 12 -16, 2019.
The company will present new safety data from the Phase 3 IMPLANT 2 trial of its oxytocin receptor antagonist nolasiban, which demonstrate favorable maternal, neonatal and infant outcomes following use of nolasiban. Also being presented are new long-term efficacy and safety data from the Phase 2b EDELWEISS trial, which show maintenance or increase of the effect of linzagolix on endometriosis-associated pain and favorable safety at the end of 52 weeks of treatment.
Oral Session Title: ART Offspring
Monday, October 14, 2019 10:45 am - 12:15 pm Eastern Daylight Time (EDT)
Abstract O-16 - 11:30 AM EDT: “Babies Born Following Administration of Nolasiban Before Embryo Transfer (ET) After IVF: Neonatal And Infant Development Outcomes From a Double-Blind, Placebo-Controlled, Clinical Trial.”
Poster Presentation Session Topic: Endometriosis
Wednesday, October 16, 2019 6.30am - 7.45am Eastern Daylight Time (EDT)
Abstract P-539: “Long Term Treatment of Endometriosis Associated Pain (EAP) with Linzagolix: Efficacy and Safety after 12 Months of Treatment.”
ObsEva will also be at Booth # 1005 of the exhibition hall.
About Nolasiban (OBE001)
Nolasiban 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.
About Assisted Reproductive Technology (ART)
Infertility affects approximately 10% of reproductive-aged couples, with more than 2 million ART treatments (including IVF and ICSI) performed worldwide each year. Currently in the United States, 62% of fresh embryo transfers are performed on Day 5 and 30% on Day 3 (CDC report, 2016 data).
While the success of ART depends on multiple factors such as embryo quality and ET procedures, successful embryo implantation and subsequent pregnancy ultimately hinge on endometrial receptivity, which may be reduced by excessive uterine contractions and suboptimal blood flow to the uterus at the time of 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. Infants are being followed-up for 6 months.
About LINZAGOLIX (OBE2109)
Linzagolix is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late stage clinical development for the treatment of endometriosis-associated pain and heavy menstrual bleeding associated with uterine fibroids. Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, resulting in a dose-dependent reduction in estrogen production by the ovaries. Linzagolix is being developed to potentially provide two regimens of administration, one targeting partial suppression of estradiol that may not necessitate add-back therapy (ABT) in the majority of patients, and one targeting full or near full estradiol suppression that would require the administration of ABT, with the goal of providing appropriate treatment to the broadest possible proportion of the endometriosis and uterine fibroid patient populations. ObsEva licensed OBE2109 from Kissei in 2015 and retains worldwide rights, excluding Asia.
Endometriosis, an estrogen-dependent gynecological condition defined as the presence of endometrial-like tissue outside the uterus, is one of the most common gynecological diseases affecting about 1 in 10 women during their reproductive years. A chronic, inflammatory reaction induced by the ectopic endometrial cells results in a variety of pain symptoms including dysmenorrhea (DYS), non-menstrual pelvic pain (NMPP), overall pelvic pain (OPP), dyspareunia and dyschezia.
About the EDELWEISS trial
EDELWEISS is a Phase 2b, randomized, double blind, placebo controlled clinical trial designed to evaluate the effects of a range of doses of linzagolix on endometriosis-associated pain and to assess safety and tolerability including effects on bone mineral density (BMD). Patients were randomized to receive either an oral once daily dose of linzagolix (50mg, 75mg, 100mg or 200mg) or placebo for up 12 weeks.
Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia, which is sold worldwide through its licensees. KLH-2109/OBE2109/linzagolix is a new chemical entity discovered by Kissei R&D and currently in development in Japan by Kissei.
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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