up Data from IMPLANT2 Trial Echoing Favorable Safety Profile
时间:2019-05-30 11:53 来源:百度新闻 作者:巧天工 点击:次
Geneva, Switzerland and Boston, MA C April 29 2019C ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a womans reproductive health and pregnancy, today announced additional neonatal and infant follow-up results from the IMPLANT2 Phase 3 trial of its oral, oxytocin receptor antagonist, nolasiban, in patients undergoing IVF procedures. These additional data, resulting from additional follow-up extending to 6 months beyond delivery for the neonates and infants, are consistent with the favorable safety profile of nolasiban observed during pregnancy and within the first month following birth. We are very pleased by the results from the follow-up of the babies born in the IMPLANT2 trial, which is consistent with prior pre-clinical and clinical data indicating that the safety of nolasiban administered at the time of embryo transfer is no different from placebo, said Dr. Ernest Loumaye, Co-Founder and Chief Executive Officer of ObsEva. Following these important results, ObsEvas final anticipated step leading to a planned MAA filing is the read-out of the second Phase 3 trial in Europe, IMPLANT4, which we continue to expect in Q4 2019. Previously reported data from the IMPLANT2 trial showed a live birth rate (LBR) of 34.8% and 27.7% (p=0.025) in the nolasiban and placebo groups, respectively, a relative 25% increase. In the subgroup of patients receiving a single embryo transfer (SET) on Day 5, LBR was 44.8% and 33.2% in the nolasiban and placebo groups, respectively, a relative 35% increase. There were 108 deliveries resulting in 109 infants in the placebo group and 131 deliveries resulting in 136 infants in the nolasiban group. Safety follow-up in the IMPLANT2 trial included neonatal outcomes assessed up to 28 days following birth, and infant development assessed using the Ages and Stages Questionnaires-3 (ASQ-3) completed 6 months following birth. Reported maternal, obstetrical, and neonatal outcomes up to 28 days post-delivery were very similar between the nolasiban and placebo groups. These measures included incidence and type of congenital malformations (reported in 5 [4%] infants in the nolasiban group and 4 [4%] infants in the placebo group), as well as the incidence of intrauterine growth restriction. At 6-months post birth, infant follow-up and developmental outcomes showed no notable differences between the nolasiban and placebo groups in terms of ASQ-3 domain score (mean SD total ASQ-3 scores were 208.7 38.8 in the placebo group and 208.51 44.7 in the nolasiban group), total score, or percentage of infants with at least one domain score below the respective cut-off value. Overall, Phase 3 IMPLANT2 trial results demonstrated that nolasiban increased rates of ongoing pregnancy and live birth following SET, with no safety concerns identified in either mothers or infants. ObsEva plans to present full safety results from the IMPLANT2 trial at a scientific conference in 2019. About the IMPLANT2 Clinical Trial IMPLANT2 is a Phase 3, randomized, double blind, clinical trial assessing nolasiban compared to placebo for improving the rate of pregnancy in patients undergoing IVF or 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 4 hours before D3 or D5 fresh, single ET. The primary endpoint was ongoing pregnancy at 10 weeks after ET. Women with confirmed pregnancies were monitored until delivery and the infants for up to 6 months following birth. About Assisted Reproductive Technology (ART) Infertility affects about 10 percent of reproductive-aged couples, with more than 2 million ART treatments (most being IVF) performed worldwide each year. Currently 59% of fresh embryo transfers are performed on D5 and 31% on D3 in the United States (CDC report, 2015 data). While the success of ART depends on multiple factors including ovarian 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 insufficient blood flow to the uterus, may impair the implantation of the embryo. About Ages and Stages Questionaire-3 (ASQ-3) The Ages and Stages Questionnaires, Third Edition (ASQ-3) is a Patient-reported outcome measure to evaluate infant developmental outcome at 6 months after birth. ASQ-3 includes 6 questions in each of the following domains: Communication, Gross motor, Fine motor, Problem solving, Personal-social 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 KGaA, Darmstadt, Germany, in 2013 and retains worldwide, exclusive, commercial rights. About ObsEva (责任编辑：波少) |