ObsEva SA Presents Clinical Data from Phase III IMPLANT 2 Trial of
Nolasiban in IVF at the American Society of Reproductive Medicine
(ASRM) Annual Meeting
- Abstract featuring-IMPLANT2 data awarded Prize
Paper by Society for Assisted Reproductive Technology
(SART)
- Nolasiban treatment shown to significantly increase
Live Birth Rate (LBR) in randomized clinical trial of patients
undergoing In Vitro Fertilization (IVF)
Geneva, Switzerland and Boston, MA –
October 9, 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 IMPLANT 2 Phase 3 clinical data of
its novel, oral, oxytocin receptor antagonist, nolasiban, in
patients undergoing IVF were presented at the 74th annual meeting
of the American Society of Reproductive Medicine (ASRM), taking
place in Denver, Colorado, October 6-10, 2018.
“We feel honored that our commitment to improve
the chances of success of IVF treatments is recognized by the award
for IMPLANT 2 from SART, the primary organization of professionals
dedicated to the practice of Assisted Reproductive Technologies
(ART) in the United States. In addition, the new data showed
an increase in live births resulting from a single nolasiban
administration prior to embryo transfer (ET) which represents
extremely important efficacy and safety follow-up from both a
clinical trial and patient perspective,” said Ernest Loumaye,
co-founder and Chief Executive Officer of ObsEva. “We are
continuing our nolasiban clinical development to bring the first
treatment at the time of ET, to couples experiencing infertility
and undergoing IVF treatment that can improve not only the
likelihood of achieving pregnancy, but also the ultimate goal of
bringing home a baby.”
In the oral presentation entitled “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” the primary endpoint results of the IMPLANT 2
trial showed an improvement in the rate of ongoing pregnancy 10
weeks post either Day 3 or Day 5 ET, with nolasiban treatment vs.
placebo, 35.6% vs. 28.5% (p=0.031), a 25% increase. For women
undergoing Day 5 ET, nolasiban resulted in an ongoing pregnancy
rate of 45.9% vs. 34.7% for placebo (p=0.034), a 32% increase.
New data of this trial presented on live birth
rate (LBR), also known as “Take Home Baby rate”, showed that
nolasiban treatment resulted in an improvement that was both
statistically and clinically significant. Treatment with a single
nolasiban 900 mg oral dose 4h prior to ET resulted in a live birth
rate of 34.8% vs. 27.7% for patients receiving placebo (p=0.025), a
26% increase. The live birth rates from women undergoing Day 5 ET
were 44.8% for those receiving nolasiban, vs. 33.2% for those
receiving placebo (p value=0.025), a 35% increase.
Importantly, the tolerability and safety profile
of nolasiban has been observed to be comparable to placebo, with no
increase in serious adverse events, in ectopic pregnancy, nor in
congenital birth defects. In addition, a secondary endpoint
of miscarriage rate from weeks 2 to 24 of gestation showed a
favourable impact from nolasiban treatment suggesting a reduced
miscarriage rate following nolasiban treatment compared to
placebo.
ObsEva recently announced regulatory feedback
from authorities in Europe and, as initially planned, is proceeding
with an additional Phase 3 clinical trial of nolasiban. This trial
is expected to begin screening patients before the end of 2018, and
will enroll up to approximately 1,000 patients undergoing IVF.
Primary endpoint results measuring ongoing pregnancy rate 10 weeks
post ET from this trial are anticipated before the end of 2019, and
with positive results are intended to support Marketing
Authorisation Application filing in the EU.
About the IMPLANT2 Clinical
Trial
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.
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 Day 3 or Day 5 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.
About Assisted Reproductive Technology
(ART)
Infertility affects about 10 % of
reproductive-aged couples, with more than 2 million ART treatments
(most being 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 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 reduced blood flow to the uterus, may impair
the implantation of the embryo.
About Nolasiban
Nolasiban (previously known as OBE001), is a
novel, 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.
###
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contact:
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DillonShauna.dillon@obseva.ch+41 22 552 1550
Investor Contact:Mario
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