Swiss-based clinical-stage biopharmaceutical company ObsEva SA has started testing in third phase 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).
The company’s CEO, Ernest Loumaye said that this is an important step for nolasiban to be brought to patients undergoing IVF, for improving their chances to take home a baby after undergoing this demanding procedure. Loumaye, who is also a co-founder of ObsEva, added that with a successful IMPLANT 4 outcome, which is the designation of the trial, the company is planning a MAA submission in Europe before the end of 2019. He said it is key step in getting ObsEva’s into a commercial company which will have the potential to lower associated health care costs.
About the trial
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. ObsEva panls to enroll 800 patients who are undergoing an IVF cycle with a Day 5 single embryo transfer (SET). The main goal of the 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, the company said.