Geneva, Switzerland and Boston, MA—ObsEva, a clinical-stage biopharmaceutical company focused on therapeutics for serious conditions that compromise reproductive health and pregnancy, has announced the initiation of the IMPLANT 4 Phase 3 clinical trial of its oral oxytocin receptor antagonist, nolasiban, for the improvement of rates of pregnancy and live birth in patients undergoing assisted reproduction technology (ART), or in-vitro fertilization (IVF).
Nolasiban 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.
Infertility affects about 10 percent of reproductive-aged couples, with more than 2 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 embryo transfer (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.
IMPLANT 4 trial is a placebo-controlled, double blind Phase 3 trial conducted in 49 clinical sites in 10 countries primarily in Europe, as well as Canada and Russia. Planned enrollment is approximately 800 patients who are undergoing an IVF cycle with a Day 5 single embryo transfer (SET). Eligible women will be randomized in a 1:1 ratio to receive either a single oral 900 mg dose of nolasiban or placebo, four hours prior to ET.
The primary endpoint of the IMPLANT 4 trial is the proportion of patients successfully achieving ongoing pregnancy 10 weeks post ET. Live birth rate (LBR) is a secondary endpoint of the trial, and follow-up will include 28-day neonatal assessment, as well as infant development assessment at 6 and 12 months post-birth. A successful IMPLANT 4 study will support a Marketing Authorization Application (MAA) in Europe, Canada, Russia and other countries such as Switzerland.
“We are very pleased by the initiation of the IMPLANT 4 trial, as this represents an important step toward bringing nolasiban to patients undergoing IVF, for improving their chances to take home a baby after undergoing this demanding procedure,” said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva. “With a successful IMPLANT 4 outcome, we are planning a MAA submission in Europe prior to the end of 2019, a key step in ObsEva’s evolution into a commercial company with a unique and innovative product that may not only help patients, but has the potential to lower associated health care costs.”
