ObsEva Starts Phase 3 Clinical Program for Nolasiban in ART
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ObsEva Starts Phase 3 Clinical Program for Nolasiban in ART
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- IMPLANT2 study to confirm efficacy and safety of novel, oral oxytocin receptor
antagonist in infertile patients undergoing embryo transfer as part of assisted
reproductive technology (ART) -
Geneva, Switzerland - 07 March 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss
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 initiation of its Phase 3 clinical program
evaluating the efficacy and safety of nolasiban to improve pregnancy and live
birth rates in women undergoing ART. The study is being conducted in 10 European
countries.
Nolasiban is an oral oxytocin receptor antagonist that potentially improves
pregnancy and live birth rates following embryo transfer (ET). In a completed
Phase 2 study, 43 percent of patients treated with 900 mg of nolasiban before ET
achieved a live birth compared to 29 percent of patients who received placebo.
"Based on our promising Phase 2 data, we are starting a large confirmatory study
to assess the efficacy and safety of a single, oral administration of 900 mg of
nolasiban before embryo transfer on either Day 3 or Day 5 following egg
retrieval," said Ernest Loumaye, MD, PhD, OB&GYN, CEO and Co-Founder of ObsEva.
"We believe that should this trial confirm an absolute increase in live birth
rates of about 10 percent, or greater, it would represent a major advance for
the patients undergoing these demanding procedures to fulfill their desire to
have a child."
The IMPLANT2 clinical trial is being conducted at approximately 50 fertility
clinics across Europe, and is expected to enroll about 760 women who are
undergoing assisted reproduction by in vitro fertilization (IVF) or
intracytoplasmic sperm injection (ICSI) for low fertility. Following ovarian
stimulation, egg retrieval and fertilization, eligible women will be randomized
to receive either a single oral dose of 900 mg nolasiban or placebo a few hours
before Day 3 or Day 5 ET. Treatment allocation will be blinded. A pregnancy test
will be done after two weeks and pregnancies confirmed by ultrasound at 6 and
10 weeks. The primary outcome is ongoing pregnancy at 10 weeks after ET. Women
with confirmed pregnancies will be monitored until the birth of their babies.
Babies will be monitored for one to six months after birth.
About Assisted Reproductive Technology
Infertility affects about 10 percent of reproductive-aged couples, with
approximately 1.6 million ART treatments (including IVF and ICSI) performed
worldwide each year.
While the success of ART depends on multiple factors such as 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 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 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-Serono in 2013 and retains
worldwide 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 ART outcomes.
ObsEva is listed on The NASDAQ Global Select Market and is trading under the
ticker symbol "OBSV". 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 trial design of OBE001, including total enrollment, as well as the potential
benefits of OBE001. 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,
ObsEva's reliance on third parties over which it may not always have full
control, and other risks and uncertainties that are described in the Risk
Factors section of ObsEva's Registration Statement on Form F-1, as amended,
declared effective by the Securities and Exchange Commission (SEC) on January
25, 2017, and other filings ObsEva makes with the SEC from time to time. These
documents are available on the Investors page of ObsEva's website at
http://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.
###
Media Contact:
Liz Bryan
Spectrum Science
lbryan(at)spectrumscience.com
202-955-6222 x2526
Company Contact:
Delphine Renaud
ObsEva, CEO Office
delphine.renaud(at)obseva.ch
+41 22 552 1550
Press Release:
http://hugin.info/157613/R/2085406/786777.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: ObsEva SA via GlobeNewswire
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