ObsEva Announces the Completion of a Phase 1 Drug-Drug Interaction Study with OBE022
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ObsEva SA /
ObsEva Announces the Completion of a Phase 1 Drug-Drug Interaction Study with
OBE022
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The issuer is solely responsible for the content of this announcement.
- OBE022 is ObsEva's potential first-in-class, oral and selective PGF2alpha
receptor antagonist for the treatment of preterm labor -
Geneva, Switzerland and Boston, MA - 18 May 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 the completion of a Phase 1
study which investigated the potential drug-drug interactions of OBE022 when
given with magnesium sulfate (MgSO4), betamethasone, atosiban, or nifedipine,
medications typically used in women with preterm labor.
"We are very pleased with the results of this Phase 1 drug-drug interaction
study which supports our initiation of a Phase 2a study commencing later this
year for the treatment of preterm labor. These data support the co-
administration of OBE022 with tocolytics to prevent pre-term birth, as well as
standard of care to improve the neonatal outcome of the premature baby." said
Jean-Pierre Gotteland, CSO of ObsEva.
OBE022 is a first-in-class, once daily, oral and selective prostaglandin
F(2alpha) (PGF2alpha) receptor antagonist, which is in development for the
treatment of preterm labor in weeks 24 to 34 of pregnancy. Based on pre-clinical
models, OBE022 may potentially match the known tocolytic efficacy of
prostaglandin inhibitors without the serious safety concerns reported with non-
specific compounds such as indomethacin or other NSAIDs.
Patients with threatened preterm delivery are usually treated with MgSO4 for
fetal neuroprotection, betamethasone for accelerating fetal lung maturation and
a tocolytic to suppress uterine activity. More than one tocolytic may be used in
combination or sequentially if the primary choice is not effective. The
combination of tocolytic treatments could potentially lead to additive or
synergistic effects on uterine contractions. As a result of the limited efficacy
and unfavorable safety profile of many current tocolytics used off-label to
treat preterm labor, we believe there remains a significant unmet need for a
selective prostaglandin inhibitor. Focus on the inhibition of only PGF2alpha to
delay preterm birth may provide a safe treatment option for both mother and
child.
The drug-drug interaction Phase 1 clinical study was a randomized, open-label,
single-centre Phase 1 study designed to assess the safety, tolerability and
pharmacokinetics of OBE022 when co-administered with MgSO4, betamethasone,
atosiban, or nifedipine to pre-menopausal healthy women. The study was performed
in two parts: (A) single dose of OBE022, 12 hours MgSO4 infusion and co-
administration of both, each separated by 7 days; (B) single dose of each of
atosiban, nifedipine and betamethasone followed by co-administration of each of
these compounds with multiple doses of OBE022.
All studied OBE022 combination treatments were safe and well-tolerated. All but
one treatment emergent adverse events (TEAE) were mild, one was moderate; there
were no serious adverse events and no clinically relevant changes in safety
parameters. No clinically significant abnormalities were detected in clinical
laboratory results and the ECG assessments including QTcF evaluation did not
reveal any clinically significant abnormalities.
Single and steady state pharmacokinetics of OBE022 and its readily formed active
stable metabolite OBE002 in pre-menopausal women were comparable to those in the
Phase 1 first-in-women study with post-menopausal women. There were no
clinically relevant interactions between OBE022 and MgSO4, betamethasone or
atosiban while nifedipine exposure was increased.
Given the results announced today, ObsEva intends to advance OBE022 into a Phase
2a Proof-of-Concept clinical trial in the second half of 2017 to assess the
safety and efficacy of OBE022 to delay birth in women 24 to 34 weeks pregnant
who face preterm labor and potentially preterm delivery.
About Preterm Labor
Preterm labor, defined as the body commencing the birthing process prior to 37
weeks, is a serious women's pregnancy health condition characterized by uterine
contractions, cervical dilation and rupture of the fetal membranes that surround
and protect the fetus during pregnancy. 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, preterm labor is a condition for which only treatments with limited
efficacy or restrictive safety issues are available. In the United States, the
evidence supports the use of first-line tocolytic treatment with beta-adrenergic
receptor agonists, calcium channel blockers, or NSAIDs 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 after tocolysis could 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
NSAIDs can also be effective for controlling preterm labor, use of such drugs is
limited, due to the threat of serious and sometimes life-threatening side
effects to 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 PGF2alpha
ObsEva is advancing OBE022, a potential first-in-class, once daily, oral and
selective PGF2alpha receptor antagonist designed to control preterm labor by
reducing inflammation, decreasing uterine contractions, and preventing cervical
changes and fetal membrane ruptures. PGF2alpha induces contraction of the
myometrium and also upregulates enzymes causing cervix dilation and membrane
rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly
reduces spontaneous uterine contractions in pregnant rats without causing the
adverse effects seen with NSAIDs.
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", "intend", "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 pharmacology study of OBE022, the potential benefits of OBE022 and
the potential clinical development plan for OBE022, including the timing and
scope of future clinical trials as well as the timing and outcome of future
interactions with the appropriate 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, 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
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:
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
781-366-5726
Press release:
http://hugin.info/157613/R/2105743/799273.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: 18.05.2017 - 12:30 Uhr
Sprache: Deutsch
News-ID 543002
Anzahl Zeichen: 11682
contact information:
Town:
Plan-les-Ouates
Kategorie:
Business News
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