“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.
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.
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
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
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.
Cautionary Note Regarding Forward Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates and the timing of enrollment in and data from clinical trials. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended
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