To date, preterm labor is a condition for which only treatments with limited efficacy or restrictive safety issues are available. This includes the off-label use of tocolytics, which have a limited efficacy in suppressing uterine contractions and delaying birth.
OBE022 is a potential first-in-class, oral and selective prostaglandin F2 alpha receptor antagonist designed to control preterm labor by reducing inflammation, decreasing uterine contractions and preventing cervical changes and membrane ruptures. ObsEva believes this is an innovative approach to controlling preterm labor and delaying birth and OBE022 is being developed as an oral treatment for patients between 24 to 34 weeks of gestation.
ObsEva presented during the second quarter of 2017 key clinical data for the Phase 1 drug-drug interaction study of OBE022 with standard of care treatments for pre-term labor. The data completed the Phase 1 program for OBE022.
Based on these Phase 1 clinical trial results, we initiated the PROLONG Phase 2a proof-of-concept clinical trial. The trial objectives are to assess the safety and efficacy of OBE022 when co-administered with atosiban, to delay birth after oral administration in pregnant women who face preterm labor and potentially preterm delivery. The targeted patient population will include women who are at least 24 weeks and less than 34 weeks pregnant, with intact membranes, presenting with spontaneous preterm labor for which they receive atosiban for 48 hours and no contraindications to a prolongation of pregnancy
View OBE022 publications here