ObsEva Reports Positive Phase 3 Results

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01.03.2018
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This week, ObsEva reported positive top line results of the IMPLANT2 Phase 3 clinical trial of its oral oxytocin receptor antagonist, nolasiban, which is being developed for improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures.

ObsEva SA is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Importantly, infertility impacts approximately 10% of reproductive aged couples, and is influenced by the trend of pregnancy desired later in reproductive lives, with annual assisted reproduction technology (ART) cycles approximating 1.6 million worldwide. 

The primary endpoint of the clinical trial was met, with an absolute increase in ongoing pregnancy rate at 10 weeks of 7.1% (placebo 28.5% and nolasiban 35.6%, p = 0.031). This represents a relative increase of 25% in the ongoing pregnancy rate after administration of nolasiban compared to placebo. In addition, nolasiban was well tolerated, with low rates of treatment discontinuation that were comparable between treatment and placebo. The safety profile of nolasiban was also similar to placebo, with a total of 9 (2.3%) serious adverse events (SAE’s) in the placebo group and 4 (1.0%) in the nolasiban group. None of these SAE’s were reported to be related to treatment.

Follow-up data from the IMPLANT2 study will include live birth rate, and 28-day neonatal safety, expected to be reported in the fourth quarter of 2018. Six-month infant follow-up is expected to be available in 2019.

"We are very pleased that the IMPLANT2 results reported today demonstrate an ongoing pregnancy benefit at 10 weeks following a single, oral dose of nolasiban, given 4 hours prior to a single ET, that not only was statistically significant, but the magnitude of which we believe represents a highly clinically meaningful improvement for the women undergoing IVF/ICSI procedures” said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva. “We believe IMPLANT2 results potentially represent one of the most important innovations in the practice of IVF/ICSI since the emergence of recombinant FSH more than 20 years ago”.

Based upon the data, ObsEva intends to seek feedback from regulatory authorities in Europe and the United States on any necessary additional clinical requirements, and also solicit guidance on the regulatory registration path forward.  ObsEva plans to provide an update on its expected nolasiban clinical and regulatory timelines following these discussions.

(Press release)

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