ObsEva SA Announces Phase 3 IMPLANT 2 Clinical Trial Results of Nolasiban in IVF to be Presented at Annual ASRM Meeting Tues...
05 Octubre 2018 - 12:00AM
ObsEva SA Announces Phase 3 IMPLANT 2 Clinical Trial Results of
Nolasiban in IVF to be Presented at Annual ASRM Meeting Tuesday
October 9, 2018
- Recipient of Prize Paper Award from the Society for
Assisted Reproductive Technology (SART)
Geneva, Switzerland and Boston, MA
- October 5, 2018- ObsEva SA (NASDAQ: OBSV /
SIX: OBSN), a Swiss 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 Phase 3
IMPLANT 2 clinical trial results will be presented at the 74th
annual meeting of the American Society of Reproductive Medicine
(ASRM) taking place in Denver, Colorado, October 6-10,
2018.
ObsEva is pleased to acknowledge that the
presentation has been awarded the Prize Paper of the Society for
Assisted Reproductive Technology (SART).
Prize Paper Session:
Tuesday, October 9 10:45
am-12:00 pm Mountain Daylight Time (MDT)
11:45 am MDT: “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”
About the IMPLANT 2 Clinical
Trial
IMPLANT 2 is a Phase 3, randomized, double
blind, clinical trial designed to confirm the efficacy of nolasiban
to increase the chance of pregnancy and live birth in patients
undergoing IVF or ICSI. Following ovarian stimulation, egg
retrieval and fertilization, eligible women were randomized to
receive either a single, oral dose of 900 mg nolasiban or placebo,
4 hours before Day 3 or Day 5 fresh, single embryo transfer (SET).
The primary endpoint was ongoing pregnancy at 10 weeks after SET.
Women with confirmed pregnancies were monitored until delivery,
with a key secondary endpoint being live birth, and the infants are
being followed-up for 6 months.
About Assisted Reproductive Technology
(ART)
Infertility affects about 10 % of
reproductive-aged couples, with more than 2 million ART treatments
(mostly IVF) performed worldwide each year. Currently 59% of fresh
embryo transfers are performed on Day 5 and 31% on Day 3 in the
United States (CDC report, 2015 data).
While the success of ART depends on multiple
factors such as embryo 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 reduced blood flow to the uterus, may impair
the implantation of the embryo.
About Nolasiban
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 patients undergoing ART. ObsEva licensed nolasiban from Merck
KGaA, Darmstadt, Germany, in 2013 and retains worldwide, exclusive,
commercial rights.
About ObsEva
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.
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For further information, please
contact:
Media Contact Switzerland and
Europe:Christophe LampsDynamics Groupcla@dynamicsgroup.ch
+41 22 308 6220 Office+41 79 476 26 87 Mobile
Media Contact U.S.:Marion
JanicRooneyPartners LLCmjanic@rooneyco.com+1 212 223 4017 Office+1
646 537 5649 Mobile
CEO Office Contact:Shauna
DillonShauna.dillon@obseva.ch+41 22 552 1550
Investor Contact:Mario
CorsoSenior Director, Investor Relationsmario.corso@obseva.com+1
857 972 9347 Office+1 781 366 5726 Mobile