ObsEva SA Announces Presentation Related to its PGF2alpha Receptor Antagonist at ACCP 2017 Annual Meeting
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ObsEva SA Announces Presentation Related to its PGF2alpha Receptor Antagonist at
ACCP 2017 Annual Meeting
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The issuer is solely responsible for the content of this announcement.
Phase 1 clinical trial results in healthy subjects support cardiac safety of
OBE022
Geneva, Switzerland and Boston, MA - 11 September, 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 that OBE022 cardiac
safety data will be presented at the 2017 Annual Meeting of the American College
of Clinical Pharmacology (ACCP), taking place September 17(th) - 19(th) in San
Diego, CA. ObsEva is developing OBE022 as a potential first-in-class, oral and
selective prostaglandin F(2alpha )(PGF(2alpha)) receptor antagonist for the
treatment of spontaneous preterm labor in weeks 24 to 34 of pregnancy.
ObsEva previously announced results from this first-in-women single and multiple
ascending dose trial in January 2017, in which favorable safety and
pharmacokinetics of OBE022 were observed. The multiple ascending dose part of
this trial also evaluated the effect of OBE022 on the heart-rate-corrected QT
interval (QTc), the regulatory biomarker for pro-arrhythmic potential, in 23
healthy post-menopausal women using the effect of a meal on QTc to assess assay
sensitivity.
OBE022 at doses up to 1000mg/d was administered orally following a standardized
breakfast on Day 1 and then daily in the fasted state from Day 3 up to Day 9.
Concentration-effect modelling was used to assess the effect of prodrug OBE022
and parent OBE002 on QTcF following both single doses (Day 1 and 3) and seven
days of multiple doses (Day 9).
ObsEva observed in these study results that neither prodrug OBE022 nor parent
OBE002 prolong the QTc-interval. In addition, food intake on Days 1, 3 and 9
resulted in an expected change in the QT - interval which supports the validity
of the assay.
"The absence of pro-arrhythmic potential is crucial for any drug development
program and particularly important when aiming to treat pregnant women. The
completion of this trial along with the rest of our Phase 1 program further
enables the planned initiation of our Phase 2a PROLONG clinical trial later this
year." said Oliver Pohl, ObsEva Vice President Non-Clinical and Phase 1.
About Preterm Labor
Preterm labor, defined as the birthing process starting prior to 37 weeks of
gestation, is a serious condition characterized by uterine contractions,
cervical dilation and rupture of the fetal membranes that can lead to preterm
birth. According to a study published in the Lancet in 2012, approximately 15
million babies were born before 37 weeks of gestation in 2010, accounting for
11.1% of all live births worldwide. Over 1 million children under the age of
five died in 2013 worldwide due to preterm birth complications, and many infants
who survive preterm birth are at greater risk for cerebral palsy, delays in
development, hearing and vision issues, and often face a lifetime of disability.
The rates of preterm births are rising in almost all countries with reliable
data for preterm birth, and are associated with an immense financial impact to
the global healthcare system.
To date, only treatments with limited efficacy or restrictive safety issues are
available to treat preterm labor. In the United States, recommended first-line
tocolytic treatments (medications that inhibit labor) include beta-adrenergic
receptor agonists, calcium channel blockers, or NSAIDs, which are used for
short-term prolongation of pregnancy (up to 48 hours) to allow for the
administration of antenatal steroids (e.g. betamethasone). Magnesium sulfate,
used for fetal neuroprotection can also be used (up to 48 hours) to inhibit
acute preterm labor. Approved tocolytic treatments in Europe include beta-
adrenergic agonists, which carry severe maternal cardiovascular risks, and
intravenous infusions of atosiban (an oxytocin receptor antagonist).
While prostaglandin inhibitors (NSAIDs) have been shown to be effective for
inhibiting preterm labor, use of such drugs is limited, due to the threat of
serious and sometimes life-threatening side effects in the fetus. Such side
effects may include kidney function impairment, premature constriction of the
blood vessel connecting the pulmonary artery and the descending aorta in a
developing fetus, and higher risk of thrombosis of the intestinal arteries (a
condition called necrotizing enterocolitis).
About OBE022 and PGF(2alpha)
ObsEva is developing OBE022, a potential first-in-class, oral and selective
prostaglandin F(2alpha) (PGF(2alpha)) receptor antagonist, which is designed to
control preterm labor by reducing inflammation, decreasing uterine contractions,
preventing cervical changes and fetal membrane rupture without causing the
potentially serious side effects to the fetus seen with non-specific
prostaglandin inhibitors (NSAIDs). PGF(2alpha) is believed to induce
contractions of the myometrium and also upregulate enzymes causing cervix
dilation and membrane rupture. In nonclinical studies, ObsEva has observed that
OBE022 markedly reduces spontaneous and induced uterine contractions in pregnant
rats without causing the fetal side effects seen with prostaglandin inhibitors
such as indomethacin.
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 clinical development of ObsEva's product candidates and the timing of
enrollment in and reporting of data from clinical trials. 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 Annual Report on Form 20-F for
the year ended December 31, 2016, and other filings ObsEva makes with the SEC.
These documents are available on the Investors page of ObsEva's website at
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
+ 1 202-955-6222 x2526
Company Contact:
CEO Office Contact
Delphine Renaud
delphine.renaud(at)obseva.ch
+41 22-552-1550
Investor Contact
Mario Corso
Senior Director, Investor Relations
mario.corso(at)obseva.com
+1 781-366-5726
Press Release:
http://hugin.info/157613/R/2132889/815339.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
Unternehmensinformation / Kurzprofil:
Datum: 11.09.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 559427
Anzahl Zeichen: 9804
contact information:
Town:
Plan-les-Ouates
Kategorie:
Business News
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