Advertisement ObsEva begins enrollment in Phase II TERM trial of OBE001 in pregnant women with preterm labor - Pharmaceutical Business review
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ObsEva begins enrollment in Phase II TERM trial of OBE001 in pregnant women with preterm labor

ObsEva, a Swiss biopharmaceutical company developing a novel generation of drugs addressing serious conditions compromising pregnancy from conception to birth, announced the recruitment of the first patient in the TERM study, a Phase II clinical trial in pregnant women with preterm labor of its lead compound OBE001, an orally active oxytocin receptor antagonist.

"We are very pleased to announce the enrolment of the first patient in this important and second indication for our lead product. This is another important milestone for the Company as we continue to develop our product portfolio according to our business plan." stated Ernest Loumaye, CEO and Co-Founder of ObsEva.

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study. It is planned to recruit 100 patients at maternity hospitals across several European countries including Belgium, Germany, Poland, Spain, Switzerland, and the UK.

"The study is being conducted at large maternity units who care for pregnant women with preterm labor, on a daily basis" added Andrew Humberstone, Head of Clinical Operations of ObsEva. "Pregnant women at a high risk of preterm delivery are invited to participate in the study. The recruited patients receive a single daily oral treatment for up to 7 days either in the hospital or after returning to their home."

The first patient was enrolled at the University Maternity Hospital Miguel Servet in Zaragoza, Spain on 11 June 2015. Dr José Manuel Campillos is the principal investigator for the TERM study at that site.

"I am excited that the University Maternity Hospital Miguel Servet is the first center to enroll a patient in this important study. We need to develop better therapies for preventing preterm birth and its adverse impact on babies." said Dr Campillos.