Company remains on track to submit Nolasiban MAA in the fourth quarter of 2019
GENEVA, Switzerland and BOSTON, MA – July 17, 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 hosted a key opinion leader (KOL) meeting in New York City on in-vitro fertilization (IVF).
At the event, three KOLs in women’s reproductive health along with company executives discussed trends in IVF, including current practice trends toward Day 5 embryo transfer, and the merits of single-embryo transfer (SET) vs. double embryo transfer (DET). Further, event participants discussed the potential clinical importance of nolasiban, ObsEva’s oral oxytocin receptor antagonist, to significantly improve the live birth rate (LBR) resulting from ET, and address the high physical, emotional and financial pain associated with failed cycles. ObsEva also provided perspectives on commercializing nolasiban in both the U.S. and Europe.
“We were honored to be joined today by three esteemed physicians from across the U.S. to discuss the IVF practice landscape and were delighted to have the opportunity to speak about nolasiban, our lead clinical candidate. Nolasiban is currently being evaluated in a Phase 3 trial in Europe, IMPLANT 4, and we are in discussion with the U.S. Food and Drug Administration (FDA) regarding a planned Phase 3 study in the U.S., IMPLANT 3, which we expect to begin late this year or early next year,” said Ernest Loumaye, M.D., Ph.D., co-founder and Chief Executive Officer of ObsEva.
“ART and IVF are growing in importance at the global level, and with that growth is an evolving standard-of-care that aims to improve outcomes for women who are looking to conceive,” he added. “Approximately 9% of women age 20-44 are affected by infertility, and despite good-quality embryos and best practice transfer techniques, IVF success rates are not optimal. Indeed, according to the 2016 Assisted Reproductive Technology Report from the CDC, a majority of embryo transfers still involve multiple embryos (mainly double), which too frequently result in multiple births. Despite that, women who have an embryo transfer still have less than 50% chance to take home a baby.”
Senior executives from ObsEva’s management team were joined at today’s event by KOLs:
- Samuel Pauli, M.D., Reproductive Endocrinologist and Surgical Director at Boston IVF;
- Vicki Schnell, M.D, Founder & Medical Director at the Center of Reproductive Medicine in Houston, TX; and
- Fady I. Sharara, M.D, Medical Director at the Virginia Center of Reproductive Medicine in Reston, VA.
“The number of IVF cycles continues to rapidly increase in the U.S. and worldwide. In addition, while practice trends have evolved in recent years, we must strive to do even better, as overall success rates below 50% and are even lower with increasing age. This is not acceptable, and we must keep working to do better through innovation and new approaches,” said Dr. Schnell.
Dr. Pauli commented, “Despite CDC and SART guidelines supporting SET, a significant number of embryo transfers are still DET to improve the chance of IVF success. A treatment like nolasiban that could meaningfully improve the success of SET would further encourage SET utilization. This would reduce the negative consequences of DET-associated multiple births and related medical risks and healthcare costs.”
Dr. Sharara added “It is very difficult for most people to comprehend the downside of cycle failure unless they have direct experience. In addition to the significant financial hurdles that patients face during their long journey to pregnancy and delivery of a baby, the emotional impact of failure is devastating and life altering.”
An archived webcast of the event including slides is available here.
About Assisted Reproductive Technology
Infertility affects about 10% of reproductive-aged couples, with more than 2 million ART treatments (including IVF and ICSI) performed worldwide each year. Currently 62% of fresh embryo transfers are performed on Day 5 and 30% on Day 3 in the United States (CDC report, 2016 data).
While the success of ART depends on multiple factors including ovarian response, fertilization, embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and insufficient blood flow to the uterus, may impair the implantation of the embryo.
Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live birth among women undergoing ART. ObsEva licensed nolasiban from Merck KGaA in 2013 and retains worldwide, exclusive commercial rights.
About IMPLANT 4
Begun in November 2018, the IMPLANT 4 trial is a placebo-controlled, double blind Phase 3 trial to be conducted in 49 clinical sites in 10 countries primarily in Europe, as well as in Canada and Russia. Planned enrollment is approximately 800 patients who are undergoing an IVF cycle with a Day 5 SET. Eligible women will be randomized in a 1:1 ratio to receive either a single oral 900 mg dose of nolasiban or placebo four hours prior to ET.
The primary endpoint of the IMPLANT 4 trial is the proportion of patients successfully achieving ongoing pregnancy 10 weeks post ET. Live birth rate is a secondary endpoint of the trial, and follow-up will include 28-day neonatal assessment, as well as infant development assessment at 6 and 12 months post-birth. A successful IMPLANT 4 study will support a Marketing Authorization Application (MAA) in Europe, Canada, Russia and other countries such as Switzerland.
ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.
Cautionary Note Regarding Forward Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates, the timing of enrollment in and data from clinical trials, the results of interactions with regulatory authorities, and the potential efficacy and commercialization of our product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, risks and uncertainties regarding challenges in launching or commercializing our product candidates, including issues related to market acceptance and reimbursement, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
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