ObsEva Delivers...

(RTTNews) - ObsEva SA (OBSV), which disclosed positive top line results from its phase III trial of fertility treatment Nolasiban in February, has reported encouraging additional data.

The phase III trial, dubbed IMPLANT 2, is assessing Nolasiban compared to placebo for improving the rate of pregnancy in women undergoing assisted reproduction by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

The trial included 778 patients from 41 fertility clinics across 9 European countries. Patients received either a single 900 mg dose of Nolasiban or placebo orally on the day of embryo transfer. The primary endpoint of the trial was ongoing pregnancy as determined by ultrasound at 10 weeks following embryo transfer.

According to the topline results reported in February of this year, the study met the primary endpoint, with an absolute increase in ongoing pregnancy rate at 10 weeks of 7.1% (placebo 28.5% and Nolasiban 35.6%).

Nolasiban has also been found to have a clean safety profile, and was well tolerated in the study.

The additional IMPANT 2 trial data reported Wednesday shows that Nolasiban significantly increased live birth rate following IVF treatment.

Live birth rate, or LBR, also called "Take Home Baby" rate, is a key secondary endpoint in the IMPLANT 2 trial, and it increased by up to 35% with Nolasiban treatment, according to the Company.

An additional phase III trial of Nolasiban is expected to begin prior to the end of this year. If all goes well as planned, the Company is targeting European Marketing Authorization Application (MAA) submission of Nolasiban by the end of 2019.

For the U.S., ObsEva is awaiting feedback from the FDA on future development plans and registration requirements, which it expects to receive prior to the end of this month.

ObsEva was trading around $7 when we alerted readers to this stock on July 9, 2017 in our report titled "It's All For Her...". The stock closed Tuesday's trading at $17.94, up 0.54%.