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- Abstract featuring-IMPLANT2 data awarded Prize Paper by
Society for Assisted Reproductive Technology(SART)
- Nolasiban treatment shown to significantly increase Live Birth Rate (LBR) in randomized clinical trial of patients undergoing In Vitro Fertilization (IVF)
“We feel honored that our commitment to improve the chances of success of IVF treatments is recognized by the award for IMPLANT 2 from SART, the primary organization of professionals dedicated to the practice of Assisted Reproductive Technologies (ART) in
In the oral presentation entitled “A Placebo-controlled, Randomized, Double Blind, Phase 3
New data of this trial presented on live birth rate (LBR), also known as “Take Home Baby rate”, showed that nolasiban treatment resulted in an improvement that was both statistically and clinically significant. Treatment with a single nolasiban 900 mg oral dose 4h prior to ET resulted in a live birth rate of 34.8% vs. 27.7% for patients receiving placebo (p=0.025), a 26% increase. The live birth rates from women undergoing Day 5 ET were 44.8% for those receiving nolasiban, vs. 33.2% for those receiving placebo (p value=0.025), a 35% increase.
Importantly, the tolerability and safety profile of nolasiban has been observed to be comparable to placebo, with no increase in serious adverse events, in ectopic pregnancy, nor in congenital birth defects. In addition, a secondary endpoint of miscarriage rate from weeks 2 to 24 of gestation showed a favourable impact from nolasiban treatment suggesting a reduced miscarriage rate following nolasiban treatment compared to placebo.
About the IMPLANT2 Clinical Trial
IMPLANT 2 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. 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 Day 3 or Day 5 fresh, single ET. The primary endpoint is ongoing pregnancy at 10 weeks after ET. Women with confirmed pregnancies are monitored until delivery and the infants for up to 6 months following birth.
About Assisted Reproductive Technology (ART)
Infertility affects about 10 % 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 Day 5 and 31% on Day 3 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 reduced blood flow to the uterus, may impair the implantation of the embryo.
Nolasiban (previously known as OBE001), is a novel, 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
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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, the timing of enrollment in and data from clinical trials and the results of interactions with regulatory authorities. 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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