ObsEva SA Announces Initiation of Phase 3 IMPLANT 4 Trial of Nolasiban in Europe, Canada and Russia for Improving IVF Outcome...
November 27 2018 - 8:00PM
Geneva, Switzerland and Boston, MA – November 28,
2018 – 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 initiation of the IMPLANT 4 Phase 3 clinical trial of its
oral oxytocin receptor antagonist, nolasiban, for the improvement
of rates of pregnancy and live birth in patients undergoing
assisted reproduction technology (ART), or in-vitro fertilization
(IVF).
"We are very pleased by the initiation of the
IMPLANT 4 trial, as this represents an important step toward
bringing nolasiban to patients undergoing IVF, for improving their
chances to take home a baby after undergoing this demanding
procedure,” said Ernest Loumaye, co-founder and Chief Executive
Officer of ObsEva. “With a successful IMPLANT 4 outcome, we are
planning a MAA submission in Europe prior to the end of 2019, a key
step in ObsEva’s evolution into a commercial company with a unique
and innovative product that may not only help patients, but has the
potential to lower associated health care costs.”
IMPLANT 4 trial is a placebo-controlled, double
blind Phase 3 trial 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 single embryo transfer (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 embryo
transfer (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 (LBR) 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 in Europe, Canada, Russia and
other countries such as Switzerland.
About Assisted Reproductive Technology
(ART)
Infertility affects about 10 percent of
reproductive-aged couples, with more than 2 million ART treatments
(including IVF and ICSI) performed worldwide each year. Currently
59% of fresh embryo transfers are performed on D5 and 31% on D3 in
the United States (CDC report, 2015 data).
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
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.
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 and the results of interactions with
regulatory authorities. 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, 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, 2017, and other filings ObsEva makes
with the SEC. 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.
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 4047 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
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