- Phase 3 IMPLANT 2 trial results showed Live Birth Rate increased by up to 35% with Nolasiban treatment
- Nolasiban safety profile not different from placebo in IMPLANT 2
- European MAA submission confirmed to be targeted for 4Q:19, commercial planning underway
- Nolasiban is a novel therapy and the first therapy of its kind to improve clinical pregnancy and live birth rates in women undergoing IVF
Live birth rate (LBR), also called “Take Home Baby” rate is a key secondary endpoint in IMPLANT 2 trial of Nolasiban in IVF, and these new results show a clinically and statistically significant benefit in favor of Nolasiban. In the primary population, combined Day 3 and Day 5 embryo transfer (ET), treatment with Nolasiban as a single 900mg oral dose 4h prior ET resulted in a live birth rate of 34.8% vs. 27.7% for patients receiving placebo, a 25% relative increase (p=0.025). The live birth rate in women undergoing Day 5 ET was 44.8% for those receiving Nolasiban, vs 33.2% for those receiving placebo, a 35% relative increase (p value=0.025). LBR is an important endpoint as live birth is the ultimate goal of couples who undergo IVF treatment. These data are very consistent with the 10-week pregnancy rate of 35.6% for Nolasiban vs. 28.5% for placebo (p=0.031) that were reported in
“We are very pleased by the results of the Phase 3. IMPLANT 2 trial of Nolasiban that showed a very significant improvement in live birth rate. We believe these exciting results represent a major advance in our efforts to offer an improved standard of care for women undergoing IVF treatment. We are working with health authorities to plan the next steps and make this treatment available to women as soon as possible” said Dr.
For the U.S.,
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 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 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 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.
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, 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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