ObsEva Announces The Completion Of Patient Recruitment In The IMPLANT2 Phase III Clinical Trial In Assisted Reproductive Technology Ahead Of Schedule
Published: Sep 06, 2017
Geneva, Switzerland and Boston, MA - 06 September, 2017 - ObsEva SA (NASDAQ: OBSV), a 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 reported completion of patient recruitment of its Phase 3 IMPLANT2 clinical trial of nolasiban (OBE001), an oral oxytocin receptor antagonist being developed with the goal of improving pregnancy and live birth rates following in vitro fertilization (IVF).
More than 1000 patients from fertility clinics across 9 European countries have been recruited, targeting randomization of at least 760 patients. IMPLANT2 enrollment has proceeded significantly ahead of plan, and initial results are now expected in the first quarter of 2018.
"We are very pleased to have completed recruitment for the IMPLANT2 study in only 6 months, significantly ahead of our original schedule, which we believe reflects the strong interest among both physicians and patients in improving fertility and pregnancy rates beyond currently available technologies." said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva.
About the IMPLANT2 Clinical Trial
IMPLANT2 is a Phase 3, randomized, double blind clinical trial assessing nolasiban compared to placebo on enhancing the rate of pregnancy in patients undergoing assisted reproduction by IVF or intracytoplasmic sperm injection (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 a few hours before Day 3 or Day 5 fresh embryo transfer (ET). The primary endpoint is ongoing pregnancy at 10 weeks after ET. Women with confirmed pregnancies will be monitored until live birth and the infants will be monitored for one to six months following birth.
About Assisted Reproductive Technology (ART)
Infertility affects about 10 percent of reproductive-aged couples, with approximately 1.6 million ART treatments (including IVF and ICSI) performed worldwide each year.
While the success of ART depends on multiple factors such as 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 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. ObsEva licensed nolasiban from Merck-Serono in 2013 and retains worldwide commercial rights.
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 ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com.
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 reporting of data from clinical trials, including IMPLANT2. 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, 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 December 31, 2016, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
CEO Office contact
+41 22 552 1550
Senior Director, Investor Relations