ObsEva highlights a positive data point from its PhIII study of new fertility drug, beats a path to regulators

ObsEva $OBSV reported that its late-stage trial of their lead therapy aimed at promoting pregnancies among women with low fertility came through with a boost in the rate of women who were expecting a child in Phase III.

The late-stage data were mixed, but the biotech was able to pinpoint a group of women with a statistically significant increase in pregnancies compared to a placebo. Now the Swiss biotech will set out to get some regulatory feedback on what they need to do to get an approval as they continue to follow these women through births and the infancy of their newborns. And investors can debate whether a marginal boost in pregnancies is enough to warrant an approval — or much of a market.

ObsEva’s stock was down slightly after the news hit.

Herman Tournaye

Researchers recruited close to 400 women undergoing IVF or another procedure aimed at boosting their chances of a pregnancy for each of two arms in the study. One arm received the drug nolasiban on day 3 after oocyte retrieval — when physicians gather the immature eggs from the ovary — but failed to demonstrate a significant improval for new pregnancies. The day 5 group, though, did, with an 11.2-point improvement (placebo 34.7% and nolasiban 45.9%, p = 0.034).

That’s where they think they have the best shot for an approval.

“As the global IVF standard of care moves to Day 5 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,” said Herman Tournaye, the principal investigator.

ObsEva in-licensed the drug from Merck Serono, intent on studying an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation.

ObsEva has struggled to make its case with investors, watching its stock price plunge after an IPO a little more than a year ago. But more recently it’s enjoyed a surge.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 25,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Biotech Primer Washington 2018

RAPS Fundamentals 2018