05 Oct Nolasiban Phase 3 IMPLANT 2 Trial: IVF Live Birth Rate Increased Up to 35%
MedicalResearch.com Interview with:
Dr. Ernest Loumaye, MD, PhD
Co-Founder and CEO
MedicalResearch.com: What is the background for this announcement? How does Nolasiban work to decrease contractions and improve uterine blood flow?
Response: The WHO has recognized infertility as a global health issue, and many couples undergo IVF treatment: there are more than 700,000 annual IVF treatment cycles in Europe and more than 200,000 in the U.S. However, more than 50% of IVF procedures do not result in pregnancy, and failure has tremendous emotional and financial costs to patients. ObsEva is dedicated to improving fertility outcomes in IVF while also supporting the use of single embryo transfer to minimize multiple births that are associated with significant health risks to mother and baby, as well as significant health costs from premature delivery.
Nolasiban works by blocking the hormone oxytocin, which is known to induce uterine contractions. Nolasiban reduces uterine contractions and could improve uterine blood flow, both effects being favourable for the embryo to properly implant.
MedicalResearch.com: What are the main findings of the recent study?
Response: The most recently released data from October 3 is from the IMPLANT2 Phase 3 trial, and the data shows an increase in live births (also called “Take Home Baby”) that result from the earlier pregnancy results, demonstrating a consistent benefit without any safety issues. A total of 778 subjects participated in the trial, and these women were randomized into groups to receive the placebo treatment or receive Nolasiban. Women treated with Nolasiban received a single 900 mg oral dose four hours prior to embryo transfer (ET), and transfers took place either on Day 3 or Day 5. The results were significant: pooled data shows that treatment with Nolasiban resulted in a live birth rate of 34.8% compared to the live birth rate of 27.7% among women treated with the placebo, this represents a relative improvement of 25%. The benefits of Nolasiban are particularly strong in patients who undergo ET 5 days post egg retrieval, with a relative improvement of 35% in live births.
In February 2018, ObsEva released the primary endpoint data from the IMPLANT2 trial of Nolasiban during IVF treatment that showed an increase in ongoing pregnancy 10 weeks post ET to 35.6% compared to 28.5% for women treated with placebo, which is very consistent with the latest live birth data.
MedicalResearch.com: What should readers take away from your report?
Response: Nolasiban is a novel drug, and it would be the first drug in the class to be approved for improving IVF outcomes. Clinical results have shown efficacy, as well as no safety issues with using the drug, which is given as a one-time oral treatment 4 hours prior to ET, and is cleared from the body within two days. A large portion of the global population takes advantage of IVF procedures as a result of infertility. Currently, there are 2 million cycles of IVF completed annually, and we feel this is in need of improved success rates given the high monetary and emotional costs for would-be parents.
MedicalResearch.com: What is the next step in research and development?
Response: We are planning additional clinical trials to begin by the end of 2018 that will supplement existing data and support future approvals. Given that trials to date have been conducted in Europe, our plan is to submit an application for approval to European regulators by the end of 2019, which could then be approved as soon as one year later. In the U.S., we are presently finalizing regulatory requirements with the FDA, so the timeline may be approximately one year behind that of Europe.
MedicalResearch.com: Is there anything else you would like to add?
Response: At ObsEva, we are singularly focused on developing and commercializing novel therapeutics for serious conditions that affect a women’s reproductive health and pregnancy. With Nolasiban, we believe that these data represent a major advancement and we are eager to work with regulators to make this treatment available to women as soon as possible. Nolasiban has the potential to increase pregnancy rates while limiting the likelihood of multiple pregnancies by improving rates even when a single ET method is employed.
IMPLANT 2 is a Phase 3, randomized, double blind, clinical trial assessing Nolasiban compared to placebo for improving the rate of pregnancy in patients undergoing IVF or ICSI due to low fertility. Following ovarian stimulation, egg retrieval and fertilization, eligible women are randomized to receive either a single, oral dose of 900 mg Nolasiban or placebo 4 hours before D3 or D5 fresh, single ET. The primary endpoint is ongoing pregnancy at 10 weeks after ET. Women with confirmed pregnancies are monitored until delivery and the infants for up to 6 months following birth.
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