ObsEva: Fifth compound in a clinical program

ObsEva, a biopharmaceutical company innovating women’s reproductive health and pregnancy therapeutics from conception to birth, announced today the initiation of a Phase 1 clinical program of OBE022, a novel, first-in-class, orally-active, small molecule prostaglandin F_2α (PGF_2α) receptor antagonist. OBE022 is being developed for the treatment of preterm labor.

This program will evaluate in 70 healthy volunteers the safety and tolerability, pharmacokinetics and pharmacodynamics of single ascending and multiple ascending oral doses of OBE022 as well as the effect of food on the absorption of OBE022. ObsEva is developing OBE022 to safely control PGF_2α – mediated inflammation, uterine contractions, membrane rupture and cervical changes, which are the key features of preterm labor resulting in preterm birth.

In preclinical studies, OBE022 was shown to inhibit spontaneous uterine contractions in pregnant rats.  Moreover, OBE022 was not observed to constrict the ductus arteriosus or impair the neo-natal renal function in this model, which is believed to be because of its specificity relating to the PGF_2α receptor. Altogether these observations support the potential of OBE022 as a tocolytic without the safety liability of NSAIDs.

“The first-in-human study program is an important step towards the development of our first-in-class, orally active, PGF_2α antagonist OBE022. This further strengthens our advanced clinical stage product pipeline. The program, designed for evaluating in healthy women, the safety, the tolerance and the pharmacokinetics properties of OBE022, will be essential for moving to Phase 2 in 2017,” stated Jean-Pierre Gotteland, Chief Scientific Officer of ObsEva.

ObsEva is a biopharmaceutical company innovating women’s reproductive health and pregnancy therapeutics from conception to birth. Between the ages of 20 and 50, millions of women worldwide suffer from reproductive health conditions that affect their quality of life and their ability to conceive or may lead to complications during pregnancy. ObsEva aims to improve upon the current treatment landscape with the development of novel, oral medicines with potentially best-in-class safety and efficacy profiles. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with multiple development programs focused on treating uterine fibroids, endometriosis, Assisted Reproductive Technology and preterm labor.