ObsEva Fertility Drug Shows Some Promise in Late-Stage Trial

Drug Product

Shares of ObsEva are climbing this morning after the company highlighted a data point from a late-stage trial that showed its fertility treatment nolasiban was successful in improving the pregnancy rate of some women following in vitro fertilization.

This morning the Swiss-based biotech said nolasiban, an oral oxytocin receptor antagonist, met its primary endpoint with an “absolute increase in ongoing pregnancy rate at 10 weeks of 7.1 percent.” Patients in the Implant2 trial received a single dose of the ObsEva drug or placebo on the day of embryo transfer. Patients were followed on Day 3 and Day 5 after oocyte retrieval. Patients on Day 5 saw significantly higher results chances of pregnancy, while the Day 3 data was disappointing and not statistically significant, the company said. The company said the results represent a “relative increase of 25 percent in the ongoing pregnancy rate after administration of nolasiban compared to placebo.”

The oral treatment was well-tolerated and the rates of those who discontinued treatment were fairly equal between placebo and nolasiban, the company said.

Ernest Loumave, co-founder and chief executive officer of ObsEva, said he was pleased with the results of the late-stage trial. The single-dose treatment showed a benefit at 10 weeks for the women who have had difficulty conceiving a child. Additionally, Loumave said the company believes the results represent a “highly clinically meaningful improvement for the women undergoing IVF/ICSI procedures.”

“We believe IMPLANT2 results potentially represent one of the most important innovations in the practice of IVF/ICSI since the emergence of recombinant FSH (follicle stimulating hormone) more than 20 years ago,” Loumave said in a statement.

ObsEva said infertility impacts approximately 10 percent of reproductive-aged couples.

During the trial, the company saw the best results in the Day 5 embryo transfer group with an absolute increase of 11.2 percent, 45.9 percent for the nolasiban group and 34.7 percent for placebo. The company said that represents a relative increase in the ongoing pregnancy rate of 32 percent after administration of nolasiban compared to placebo. Lead investigator Herman Tournaye, head of the Centre for Reproductive Medicine at University Hospital Brussels, pointed to the Day 5 transfer as significantly relevant for women undergoing IVF and hoping to successfully conceive.

“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,” Tournaye said in a statement.

Following the results from the Phase III Implant2 study, ObsEva said it will seek feedback from regulatory agencies in Europe and the United States on a path forward to possible approval, which it said could include additional clinical requirements. Follow-up data from the study that will include live birth rate and 28-day neonatal safety will be reported in the fourth quarter of this year, the company said. Six-month infant follow-up is expected to be available in 2019.

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