ObsEva presents clinical data from Phase 3 trial of Nolasiban
ObsEva announced that IMPLANT 2 Phase 3 clinical data of its novel, oral, oxytocin receptor antagonist, nolasiban, in patients undergoing IVF were presented at the 74th annual meeting of the American Society of Reproductive Medicine, taking place in Denver, Colorado, October 6-10, 2018. In the oral presentation entitled "A Placebo-controlled, Randomized, Double Blind, Phase 3 Study Assessing Ongoing Pregnancy Rates After Single Oral Administration of a Novel Oxytocin Receptor Antagonist, Nolasiban, Prior to Single Embryo Transfer" the primary endpoint results of the IMPLANT 2 trial showed an improvement in the rate of ongoing pregnancy 10 weeks post either Day 3 or Day 5 ET, with nolasiban treatment vs. placebo, 35.6% vs. 28.5%, a 25% increase. For women undergoing Day 5 ET, nolasiban resulted in an ongoing pregnancy rate of 45.9% vs. 34.7% for placebo, a 32% increase. Importantly, the tolerability and safety profile of nolasiban has been observed to be comparable to placebo, with no increase in serious adverse events, in ectopic pregnancy, nor in congenital birth defects. In addition, a secondary endpoint of miscarriage rate from weeks 2 to 24 of gestation showed a favourable impact from nolasiban treatment suggesting a reduced miscarriage rate following nolasiban treatment compared to placebo.