Exhibit 99.1
ObsEva Announces Clearance to Initiate Pivotal US Phase 3 Clinical
Trial (IMPLANT 3) of Nolasiban in Women Undergoing Embryo
Transfer Following IVF
FDA Allows IMPLANT 3 Trial to Begin
Geneva, Switzerland and Boston, MA – October 31, 2019 – ObsEva SA (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 that the U.S. Food and Drug Administration (FDA) has allowed the Company to begin enrolling patients in IMPLANT 3, the U.S pivotal Phase 3 clinical trial of nolasiban in women undergoing embryo transfer (ET) followingin-vitro fertilization (IVF).
Nolasiban is an oral oxytocin receptor antagonist currently being studied for this use in a confirmatory Phase 3 European trial known as IMPLANT 4. Based on communications between ObsEva and FDA (including an End of Phase 2 meeting early this year), ObsEva submitted the current IMPLANT 3 protocol to the Company’s IND, seeking to conduct the Phase 3 clinical trial. IMPLANT 3 is the first study of nolasiban in the United States and will evaluate efficacy in increasing the number of live births and safety compared to placebo, in a total of approximately 1,100 women undergoing a Day 5 transfer of a single, fresh embryo.
“FDA clearance of the protocol, allowing us to conduct a pivotal Phase 3 clinical trial for nolasiban in IVF, is a critical step in continuing to advance our development plan for this compound. We are extremely pleased with the collaborative and constructive relationship we have had so far with the FDA that has led us to this important point. With the IMPLANT 4 results anticipated this quarter, and subsequent planned MAA filing in Europe, we are rapidly progressing toward our goal of bringing a major therapeutic advancement to patients undergoing IVF,” said Ernest Loumaye, CEO andco-Founder of ObsEva. “There remain important milestones, of course, but we are confident and look forward to European and U.S. review of our applications, once submitted,” continued Loumaye.
About Assisted Reproductive Technology (ART)
Infertility affects approximately 10% of reproductive-aged couples, with more than 2 million ART treatments (including IVF and ICSI) performed worldwide each year. Currently in the United States, 62% of fresh embryo transfers are performed on Day 5 and 30% on Day 3 (CDC Assisted Reproductive Technology report, 2016 data).
