ObsEva completes recruitment for Phase 3 trial of nolasiban
ObsEva (NASDAQ:OBSV) completed patient recruitment for its Phase 3 trial of nolasiban for the improvement of rates of pregnancy and live birth in patients undergoing assisted reproduction technology or in-vitro fertilization (IVF).
Nolasiban, an oral oxytocin receptor antagonist, is designed to decrease uterine contractions, improve uterine blood flow and enhance endometrial receptivity to embryo implantation.
The international trial, called IMPLANT 4, will enrol some 820 patients undergoing embryo transfer (ET) following IVF. Key efficacy endpoints include the proportion of patients achieving ongoing pregnancy 10 weeks post ET, and live birth rate.
“With a successful IMPLANT 4 outcome and planned marketing authorization application in Europe, ObsEva is evolving into a commercial company with a unique and innovative product that may not only help patients, but has the potential to lower associated healthcare costs,” Ernest Loumaye, ObsEva’s co-founder and CEO, said in a statement.
The company plans to report primary endpoint results in the fourth quarter of 2019.