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Nolasiban (OBE001)—Assisted Reproductive Technology

Nolasiban is an oral oxytocin receptor antagonist with the potential to decrease contractions and improve uterine blood flow hence enhancing the receptivity of the endometrium to embryo implantation. This may increase the rates of successful implantation, clinical pregnancy, and live-births among patients undergoing ART, or more specifically IVF procedures.

The Phase 2 dose-ranging IMPLANT clinical trial (n=247) showed that a single oral 900 mg dose of nolasiban about 4 h before fresh, day 3, single or double embryo transfer had the highest increase in on-going pregnancy and live birth rates compared to lower doses of 100 and 300 mg and placebo.

ObsEva initiated IMPLANT 2, a European Phase 3 clinical trial of nolasiban for ART late in the first quarter of 2017.

The Phase 3 IMPLANT 2 met its positive primary endpoint. Top line results disclosed in February, 2018 demonstrated Nolasiban given as a single oral 900 mg dose, about 4 h before fresh, day 3 or day 5, single embryo transfer, significantly increased ongoing pregnancy rate at 10 weeks in the pooled (day 3 and day 5) population (28.5% and 35.6% in the placebo and nolasiban 900 mg groups respectively, p=0.031, n=778). Furthermore, in a pre-defined subgroup analysis for the primary endpoint, there was a significant increase in ongoing pregnancy rate in the day 5, single embryo transfer, subgroup by a relative 32% (absolute ongoing pregnancy rates were 34.7% and 45.9% in the placebo and nolasiban 900 mg groups, respectively, p=0.034, n=390).

In both studies, 900 mg nolasiban was well tolerated with a safety profile very similar to placebo.

View Nolasiban publications here

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