ObsEva SA Announced Positive Topline Results of the PROLONG Proof-of-Concept Trial of Ebopiprant (OBE022) for Treatment of Preterm Labor
ObsEva SA (NASDAQ: OBSV) announced the positive topline results of PROLONG, the Phase 2a proof-of-concept, randomized, double-blind, placebo-controlled trial of ebopiprant in preterm labor.
· 11/16/2020 05:48
ObsEva SA (NASDAQ:OBSV) announced the positive topline results of PROLONG, the Phase 2a proof-of-concept, randomized, double-blind, placebo-controlled trial of ebopiprant in preterm labor. Ebopiprant is a new, first in class, orally active, selective prostaglandin F2α (PGF2α), receptor antagonist designed to treat preterm labor by reducing uterine contractions and cervical maturation while avoiding the adverse neonatal side-effects associated with non-specific prostaglandin inhibitors such as Indomethacin. One of the key objectives in reducing the mortality and morbidity associated with preterm birth is delaying delivery for at least 48 hours thereby allowing for the administration and the full effect of critical drugs that induce lung maturation and neural protection for the neonate "Assessing the therapeutic potential of a new chemical entity in pregnant women is a major challenge and I would like to thank the participating patients and congratulate our team for successfully completing this unique study. Today, no approved options are available in the United States for treatment of women with preterm labor. The encouraging PROLONG results offer new hope for these women and their babies. Furthermore, the results support the potential for improving the standard of care in Europe and Asia." said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva. "Building on the strong effect seen at 48 hours, the Phase 2b dose range finding, including testing of higher doses, will allow us to more fully define this product's potential and the longer-term benefits for babies." In this study, 113 women with spontaneous preterm labor (gestational age between 24 and 34 weeks) were randomized and treated with atosiban (ex-U.S. standard of care) plus ebopiprant or atosiban plus placebo for 7 days. There were 83 (73%) women with singleton pregnancies and 30 (27%) with twin pregnancies. One hundred and forty-one neonates were born. In the PROLONG study, ebopiprant reduced delivery in singleton pregnancies at 48 hours after the start of dosing by 55% compared to atosiban alone. Overall, 7/56 (12.5%) of women receiving ebopiprant delivered within 48 hours of starting treatment compared to 12/55 (21.8%) receiving placebo (OR 90% CI: 0.52 (0.22, 1.23)). In singleton pregnancies, 5/40 (12.5%) of women receiving ebopiprant delivered within 48 hours compared to 11/41 (26.8%) receiving placebo (OR 90% CI: 0.39 (0.15, 1.04)). A modest effect on delivery at 7 days was seen in the singletons. The incidence of maternal, fetal and neonatal adverse events were comparable between subjects in the ebopiprant group and the placebo group. "We desperately need new medical treatments for preterm labor to reduce the incidence of preterm birth, which accounts for about 10% of all births." said Professor Ben Mol, Professor of Obstetrics and Gynecology, Monash University, Australia. "The development of ebopiprant is exciting and the results of PROLONG are promising. A delay of delivery by 48 hours is extremely important as this allows transfer of women to a center with neonatal intensive care facilities, and it allows corticosteroids administered to the mother to have maximal effectiveness for the baby."