Advertisement ObsEva releases positive results from Phase I trial of OBE001 to treat preterm labour - Pharmaceutical Business review
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ObsEva releases positive results from Phase I trial of OBE001 to treat preterm labour

Swiss biopharmaceutical firm ObsEva has reported positive results from a Phase I drug interaction trial of its new orally active oxytocin receptor antagonist, OBE001, designed to treat preterm labour.

The trial evaluated the safety, tolerability and pharmacokinetics of OBE001 and betamethasone, a corticosteroid, when co-administered to healthy non-pregnant women.

Betamethasone is administered to prevent respiratory distress syndrome in threatened preterm labour patients.

ObsEva CEO and co-founder Ernest Loumaye said: "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 I 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 III enabling Phase II study."

The open-label, randomised, 3-way crossover trial conducted in 12 healthy women 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.

OBE001 is a new generation oxytocin antagonist, which are potent inhibitors of uterine contractions.

Currently, OBE001 is being evaluated in a Phase III enabling Phase II trial for improving embryo implantation and clinical pregnancy rate in women undergoing IVF/ICSI.