ObsEva Announces Completion of Phase 1 First-in-Women Study of OBE022 for the Treatment of Preterm Labor
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ObsEva SA /
ObsEva Announces Completion of Phase 1 First-in-Women Study of OBE022 for the
Treatment of Preterm Labor
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The issuer is solely responsible for the content of this announcement.
- First-in-class orally active prostaglandin F2alpha receptor antagonist
designed to safely control inflammation, uterine contractions, membrane ruptures
and cervical changes that can result in preterm birth -
Geneva, Switzerland, 13 January 2017 - ObsEva, a biopharmaceutical company
focused on the development and commercialization of novel therapeutics for
serious conditions that impact a woman's reproductive health and pregnancy,
announced today the completion of a Phase 1 single and multiple ascending dose
study of OBE022, a potential first-in-class, once daily, oral and selective
prostaglandin F(2alpha), or PGF(2alpha), receptor antagonist for the treatment
of preterm labor in weeks 24 to 34 of pregnancy. ObsEva is developing OBE022 to
safely control PGF(2alpha)-mediated inflammation, decreasing uterine
contractions and preventing membrane ruptures and cervical changes, which are
the key features of preterm labor resulting in preterm birth. The study
evaluated the safety, tolerability and pharmacokinetics of OBE022 in healthy
post-menopausal female volunteers after single doses of 10 to 1,300 mg and
multiple doses between 100 and 1,000 mg/day over 7 consecutive days.
Based on preliminary data from the single and multiple doses administered in the
Phase 1 study, OBE022 was observed to be readily absorbed and converted into the
active stable metabolite OBE002. Exposure to OBE002 increased with dose of
OBE022 and reached clinically meaningful exposure levels within an hour after
administration, which is an important feature for orally administered preterm
labor treatments. Median OBE002 half-lives were observed to be between 7 and 15
hours, which ObsEva believes is an adequate half-life for OBE022 to have once or
twice daily dosing. Single and multiple administrations of OBE022 were well
tolerated at all doses. There were no serious adverse events and no clinically
relevant changes in safety parameters.
Jean-Pierre Gotteland, CSO of ObsEva stated: "The successful completion of the
OBE022 Phase 1 first-in-women study is paving the way for the further evaluation
of OBE022 in a Phase 2 study in 2017 to assess its safety and efficacy to delay
birth after oral administration in pregnant women who face preterm labor and
potentially preterm delivery in weeks 24 to 34 of pregnancy."
- ends -
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 are 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 may have
lifelong health problems such as 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.
About OBE022 and PGF2alpha
OBE022 is a first-in-class, once daily, oral and selective prostaglandin
F(2alpha) (PGF(2alpha)) receptor antagonist currently in Phase 1 clinical
development for the treatment of preterm labor. PGF(2alpha) induces contraction
of the myometrium and also upregulates enzymes causing cervix dilation and
membrane rupture. ObsEva is developing OBE022 to safely control inflammation
through specific inhibition of the PGF(2alpha) receptor, which has the potential
to decrease uterine contractions and prevent cervical changes and membrane
ruptures resulting from preterm labor. In preclinical studies, ObsEva has
observed that OBE022 markedly reduces spontaneous uterine contractions in
pregnant rats without causing the adverse effects seen with the NSAID
indomethacin.
About ObsEva
ObsEva is a biopharmaceutical company innovating women's reproductive health and
pregnancy therapeutics from conception to birth. Between the ages of 15 and 49,
millions of women worldwide suffer from reproductive health conditions that
affect their quality of life or their ability to conceive and may lead to
complications during pregnancy. ObsEva aims to improve upon the current
treatment landscape with the development of novel, oral medicines with
potentially best-in-class safety and efficacy profiles. Through strategic in-
licensing and disciplined drug development, ObsEva has established a clinical-
stage pipeline with multiple development programs focused on treating the
symptoms associated with uterine fibroids and endometriosis, improving clinical
pregnancy and live birth rates in women undergoing in vitro fertilization, and
treating preterm labor. For more information, please visit www.ObsEva.com.
MEDIA CONTACT
Liz Bryan
Spectrum Science
lbryan(at)spectrumscience.com
202-955-6222 x2526
COMPANY CONTACT
Delphine Renaud
ObsEva, CEO Office
delphine.renaud(at)obseva.ch
+41 22 552 1550
Press Release:
http://hugin.info/157613/R/2071011/778198.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: 13.01.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 517497
Anzahl Zeichen: 6611
contact information:
Town:
Plan-les-Ouates
Kategorie:
Business News
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