ObsEva SA Reports Initial Good Safety of OBE022 in Pregnant Women

- January 23rd, 2019

ObsEva (NASDAQ:OBSV/SIX:OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced the completion of Part A of the PROLONG trial in preterm labor. In this trial, OBE022 was administered daily for 7 days, to pregnant women, who were … Continued

ObsEva (NASDAQ:OBSV/SIX:OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced the completion of Part A of the PROLONG trial in preterm labor. In this trial, OBE022 was administered daily for 7 days, to pregnant women, who were already receiving standard of care therapy for preterm labour, atosiban infusion for 48 hours. The goal was to assess the safety and pharmacokinetics of OBE022 in patients.

As quoted in the press release:

Part A was an open-label trial of OBE022 administered orally, with a loading dose of 1000 mg, then 500 mg twice a day for 7 days to pregnant women with threatened preterm labor. The nine women in Part A were between 28 and 34 weeks of gestation and were receiving a standard-of-care therapy for threatened preterm labor, atosiban infusion for 48 hours. OBE022 pharmacokinetics and maternal, fetal and infant safety were assessed. Fetal cardiac safety was monitored using Doppler ultrasound. Time to delivery was also measured. Eight of the nine patients did not deliver within the 7 days of OBE022 treatment and one patient delivered the day after starting OBE022. OBE022 was well absorbed from Day 1 to Day 7 and steady-state serum concentrations and pharmacokinetics were comparable to those observed previously in non-pregnant women. Two serious adverse events were reported in one infant but were not related to study drug. There were 22 non-serious adverse events, all mild or moderate, of which one (fatigue), was considered as related to study drug. There were no adverse events reported for the fetuses, and no clinically significant abnormal findings on the Doppler ultrasound including no constrictive effect on the ductus arteriosus. The results will be presented at the 66th Annual Scientific Meeting of the Society for Reproductive Investigation 12 to 16 Mar 2019 in Paris, France.

Part B, is a randomized, double-blind, placebo-controlled, parallel-group trial to assess the efficacy, safety and pharmacokinetics of OBE022. It is planned to recruit 120 patients with preterm labor at a gestational age of 24 to 34 weeks. As in Part A, OBE022 or placebo will be administered orally, with 1000 mg as a starting dose, then 500 mg twice a day for 7 days to women already receiving atosiban infusion for 48 hours.

Click here to read the full press release.

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