ObsEva’s has recently cleared with the U.S. Food and Drug Administration (FDA) several important development issues for its oral oxytocin receptor antagonist nolasiban, which enables it to begin its U.S. Phase 3 clinical trial (IMPLANT 3) in the fourth quarter of this year or early 2020.
According to the press release from ObsEva on Wednesday, the EOP2 meeting addressed a range of issues important to the trial design of nolasiban for increasing the rate of live births in women undergoing single blastocyst transfer (Day 5 SET) following in vitro fertilization (IVF). The official meeting minutes, reflect alignment between ObsEva and FDA on many issues, and useful dialogue on topics that are the subject of ongoing discussions, the company said. Now, ObsEva expects to work with FDA on certain issues, including timing of randomization and number of previous IVF failures.
The company said in the press release that it expects to submit the IMPLANT 3 trial protocol with an updated IND in the third quarter of 2019.
“We had a very constructive dialogue with the FDA and are pleased by the important clarifications we received on the development path for nolasiban in the U.S.,” said Dr. Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva, is satisfied with a constructive dialogue and clarifications with the FDA.
He said: “We look forward to assessing the potential benefit of nolasiban for U.S. patients undergoing embryo transfer following IVF, as we put in place the building blocks for regulatory filings in critical geographies. Our first filing, anticipated for later this year, will be a marketing authorization application (MAA) in Europe based on IMPLANT 2 and IMPLANT 4 trial results.”