Swiss-based biopharmaceutical company ObsEva has commenced the Phase I clinical programme of OBE022 to treat pre-term labour.
OBE022 is a first-in-class, orally active, small molecule prostaglandin F2alpha (PGF2alpha) receptor antagonist.
The trial will include 70 healthy volunteers to determine the safety and tolerability, pharmacokinetics and pharmacodynamics profile of OBE022 when administered in single ascending and multiple ascending oral dosages.
ObsEva chief scientific officer Jean-Pierre Gotteland said: "The first-in-human study programme is an important step towards the development of our first-in-class, orally active, PGF2alpha antagonist OBE022.
“This further strengthens our advanced clinical stage product pipeline.
“The programme is designed for evaluating in healthy women the safety, tolerance and pharmacokinetics properties of OBE022, and will be essential for moving to Phase II in 2017."
Pre-term labour is a serious women's pregnancy health condition, resulting in a premature uterus contractions and causing a premature birth prior to 37 weeks of gestation.
PGF2alpha contracts the myometrium, a muscle tissue of womb, causing metabolites to rise in amniotic fluid before and during labour.
It also triggers enzymes to dilate the cervix and resulting to a membrane rupture.
OBE022 is designed to inhibit the PGF2alpha receptor, thereby safely controlling inflammation.
In previously conducted clinical studies, ObsEva has noted that OBE022 prevent spontaneous uterine contractions in pregnant rats without causing the adverse effects seen when compared with other prostaglandin synthesis inhibitors such as Indomethacin.