Obseva Announces That Nolasiban Implant 4 Study Did Not Meet Primary Endpoint
November 07 2019 - 1:00AM
Company to Discontinue Current
Nolasiban IVF Program
Geneva, Switzerland and Boston, MA –
November 7, 2019 – ObsEva SA (NASDAQ: OBSV / SIX:
OBSN), a biopharmaceutical company developing and commercializing
novel therapies to improve women’s reproductive health, today
announced that the Phase 3 clinical trial results from its European
confirmatory study of nolasiban (IMPLANT 4) in women undergoing
embryo transfer (ET) following in-vitro fertilization (IVF) did not
meet the primary endpoint of an increase in ongoing pregnancy rate
at 10 weeks, (39.1 % placebo vs 40.5 % nolasiban) (p = 0.745).
Nolasiban was well tolerated. All subjects will continue to be
followed up to delivery and infant development will be assessed up
to 6 months.
IMPLANT4 is a randomized, double blind, placebo
controlled clinical trial that included 807 patients from more than
40 fertility clinics across nine European countries. Women
undergoing a Day 5 transfer of a single, fresh embryo were
randomized to receive either a single 900 mg dose of nolasiban or
placebo (1:1) 4 hours prior to ET. The primary endpoint of
the trial was ongoing pregnancy as determined by ultrasound at 10
weeks following ET.
"We are extremely disappointed with these
unexpected results, not in the least for the millions of women
hoping to have a baby through IVF. I would like to acknowledge the
excellent execution of the study by our employees, and to thank our
investigators as well as the women who participated in our trials,”
said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of ObsEva.
“Based on these results, we have decided to discontinue the current
nolasiban IVF program and will explore potential repositioning of
the product candidate. We remain more committed than ever to
developing our innovative pipeline of late-stage products aimed at
unmet needs in uterine fibroids, endometriosis and preterm labor
and will focus our resources on these programs immediately.”
Conference Call
ObsEva will host a conference call and audio
webcast today beginning at 8:00 a.m. Eastern Time/2:00 p.m. Central
European Time to discuss IMPLANT 4 trial results and third quarter
financial results. Investors may participate by dialing (844)
419-1772 for U.S. callers or +1 (213) 660-0921 for international
callers and referring to conference ID 9273485. A live or
archived webcast of the conference call can be accessed under the
“Investors” section of ObsEva’s website www.obseva.com.
About Nolasiban
Nolasiban (previously known as OBE001), is an
oral oxytocin receptor antagonist which was licensed
from Merck KGaA, Darmstadt, Germany, in 2013. ObsEva
retains worldwide, exclusive, commercial rights.
About linzagolix
Linzagolix (previously known as OBE2109) is a novel, orally
administered GnRH receptor antagonist with a potentially
best-in-class profile in late-stage clinical development for the
treatment of heavy menstrual bleeding associated with uterine
fibroids and pain associated with endometriosis. ObsEva licensed
linzagolix from Kissei in late 2015 and retains worldwide
commercial rights, excluding Asia, for linzagolix.
About OBE022
ObsEva is developing OBE022, a potential
first-in-class, once daily, oral and selective prostaglandin
F2alpha receptor antagonist for the treatment of preterm labor.
OBE022 was licensed from Merck KGaA,
Darmstadt, Germany, in 2015. ObsEva retains worldwide,
exclusive, commercial rights.
About ObsEva
ObsEva is a biopharmaceutical company developing
and commercializing novel therapies to improve women’s reproductive
health and pregnancy. Through strategic in-licensing and
disciplined drug development, ObsEva has established a late-stage
clinical pipeline. 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 statements regarding the potential to reposition
nolasiban. 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 and clinical development
and related regulatory reviews and approvals, including the risk
that the results of earlier clinical trials may not be predictive
of the results of later-stage 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 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 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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