ObsEva reports positive Phase III data from IMPLANT2 trial

28th February 2018 (Last Updated February 28th, 2018 00:00)

ObsEva has reported encouraging top-line results from the Phase III IMPLANT2 clinical trial of nolasiban in comparison with placebo to improve the rate of pregnancy in patients undergoing in-vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI) procedures due to low fertility. 

ObsEva has reported encouraging top-line results from the Phase III IMPLANT2 clinical trial of nolasiban in comparison with placebo to improve the rate of pregnancy in patients undergoing in-vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI) procedures due to low fertility.

IMPLANT2 is a randomised, double-blind, placebo-controlled study that enrolled 778 patients from 41 fertility clinics across nine European countries.

During the trial, patients were given either a single 900mg dose of nolasiban or placebo orally on the day of embryo transfer (ET).

Patients undergoing single, fresh ET on day three or on day five after oocyte retrieval were included in the trial.

The study's primary endpoint was ongoing pregnancy as measured by ultrasound at ten weeks following ET.

IMPLANT2 principal investigator Herman Tournaye said: “As the global IVF standard of care moves to day five embryo transfer, the IMPLANT2 results are highly relevant in that an approximate 30% increase in ongoing clinical pregnancy would constitute a major step forward in the field.”

"IMPLANT2 results are highly relevant in that an approximate 30% increase in ongoing clinical pregnancy would constitute a major step forward in the field."

Top-line data from the IMPLANT2 feature efficacy and safety information up to week ten of pregnancy following embryo transfer.

The trial also met its primary endpoint, with an absolute increase in ongoing pregnancy rate at ten weeks of 7.1%, which shows a relative increase of 25% in the ongoing pregnancy rate after administration of nolasiban compared to placebo.

The ET D5 subgroup achieved an absolute increase of 11.2% in favour of nolasiban. This marks a relative increase in an ongoing pregnancy rate of 32% after administration of nolasiban against placebo.

In the ET D3 subgroup, a statistically non-significant 3.1% absolute increase was reported in favour of nolasiban, or a 14% relative increase was seen in ongoing pregnancy rate after administration of nolasiban compared to placebo.

IMPLANT2 trial also found that nolasiban was well-tolerated, with low rates of treatment discontinuation that were comparable between treatment and placebo.

Nolasiban’s safety profile was also similar to placebo, with nine serious adverse events in the placebo group and four in the nolasiban group.