ObsEva announced additional neonatal and infant follow-up results from the IMPLANT2 Phase 3 trial of its oral, oxytocin receptor antagonist, nolasiban, in patients undergoing IVF procedures. These additional data, resulting from additional follow-up extending to 6 months beyond delivery for the neonates and infants, are consistent with the favorable safety profile of nolasiban observed during pregnancy and within the first month following birth. Previously reported data from the IMPLANT2 trial showed a live birth rate, or LBR, of 34.8% and 27.7% in the nolasiban and placebo groups, respectively, a relative 25% increase. In the subgroup of patients receiving a single embryo transfer, or SET, on Day 5, LBR was 44.8% and 33.2% in the nolasiban and placebo groups, respectively, a relative 35% increase. There were 108 deliveries resulting in 109 infants in the placebo group and 131 deliveries resulting in 136 infants in the nolasiban group. Safety follow-up in the IMPLANT2 trial included neonatal outcomes assessed up to 28 days following birth, and infant development assessed using the Ages and Stages Questionnaires-3, or ASQ-3, completed 6 months following birth. Reported maternal, obstetrical, and neonatal outcomes up to 28 days post-delivery were very similar between the nolasiban and placebo groups. These measures included incidence and type of congenital malformations, as well as the incidence of intrauterine growth restriction. At 6-months post birth, infant follow-up and developmental outcomes showed no notable differences between the nolasiban and placebo groups in terms of ASQ-3 domain score, total score, or percentage of infants with at least one domain score below the respective cut-off value. Overall, Phase 3 IMPLANT2 trial results demonstrated that nolasiban increased rates of ongoing pregnancy and live birth following SET, with no safety concerns identified in either mothers or infants.
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