SBA Member, 28.11.2018
ObsEva SA (NASDAQ: OBSV / SIX: OBSN), 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 announced 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).
"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.”
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 in 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 embryo transfer (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 in Europe, Canada, Russia and other countries such as Switzerland.