ObsEva Reports Positive Phase 1 Results for Its Lead Compound Treating Preterm Labour

ObsEva, a Swiss biopharmaceutical company developing a novel generation of drugs addressing serious conditions compromising pregnancy from conception to birth, announced today the results of a Phase 1 drug interaction study for its lead compound, OBE001. OBE001 is a novel orally active oxytocin receptor antagonist, which ObsEva is developing for the treatment of preterm labour. The study was designed to assess the safety, tolerability and pharmacokinetics of OBE001 and betamethasone when co-administered to healthy non-pregnant women. Betamethasone is a corticosteroid systematically administered to prevent respiratory distress syndrome in threatened preterm labour patients.  The results of this phase 1 study have been published today in the Journal of Clinical Pharmacy and Therapeutics and are available on the journal website.

“Demonstrating rapid absorption of the drug and absence of clinically relevant drug interactions with standard of care for this condition is essential. The results of this phase 1 study constitute an important step towards the development of OBE001 in preterm labour patients. Preterm labour is a second indication for OBE001, the lead indication being improvement of embryo implantation and clinical pregnancy rate in women undergoing IVF/ ICSI for which patient recruitment is ongoing in a Phase 3 enabling Phase 2 study” stated Ernest Loumaye, CEO and Co-Founder of ObsEva.

The study was an open-label, randomised, 3-way crossover design and was performed in 12 healthy women. It showed that after oral administration OBE001 is rapidly absorbed with targeted therapeutic plasma levels reached within thirty minutes and maximal serum concentrations reached in a couple of hours. Moreover, co-administration of OBE001 and betamethasone did not adversely impact their respective pharmacokinetics. Both drugs, either alone or in combination, were well tolerated.

“In clinics, it will thus be feasible to administer betamethasone in patient treated with OBE001 for threatened preterm labour and this will not require any specific precaution or administration adaptation” added Oliver Pohl, Senior Director Non-Clinical Development and Phase 1 of ObsEva.