ObsEva Announces Recruitment of the First Patient in TERM Phase 2 Study
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ObsEva SA /
ObsEva Announces Recruitment of the First Patient in TERM Phase 2 Study
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- Clinical Trial to Evaluate the Safety and Efficacy of OBE001 for Delaying
Spontaneous Preterm Labor in Pregnant Women -
Geneva, Switzerland, 23 June 2015 - ObsEva, a Swiss biopharmaceutical company
developing a novel generation of drugs addressing serious conditions
compromising pregnancy from conception to birth, announced today the recruitment
of the first patient in the TERM study, a Phase 2 clinical trial in pregnant
women with preterm labor of its lead compound OBE001, an orally active oxytocin
receptor antagonist.
"We are very pleased to announce the enrolment of the first patient in this
important and second indication for our lead product. This is another important
milestone for the Company as we continue to develop our product portfolio
according to our business plan." stated Ernest Loumaye, CEO and Co-Founder of
ObsEva.
The study is a prospective, randomized, parallel group, double-blind, placebo-
controlled study. It is planned to recruit 100 patients at maternity hospitals
across several European countries including Belgium, Germany, Poland, Spain,
Switzerland, and the UK.
"The study is being conducted at large maternity units who care for pregnant
women with preterm labor, on a daily basis" added Andrew Humberstone, Head of
Clinical Operations of ObsEva. "Pregnant women at a high risk of preterm
delivery are invited to participate in the study. The recruited patients receive
a single daily oral treatment for up to 7 days either in the hospital or after
returning to their home."
The first patient was enrolled at the University Maternity Hospital Miguel
Servet in Zaragoza, Spain on 11 June 2015. Dr José Manuel Campillos is the
principal investigator for the TERM study at that site.
"I am excited that the University Maternity Hospital Miguel Servet is the first
center to enroll a patient in this important study. We need to develop better
therapies for preventing preterm birth and its adverse impact on babies." said
Dr Campillos.
- Ends -
About Preterm Labor
According to The Global Action Report on Preterm Birth "Born Too Soon" issued by
World Health Organization in 2012, 15 million babies are born too soon (born
before 37 weeks of gestation) every year. This represents more than 1 in 10
babies worldwide. Over 1 million children die each year due to complications of
preterm birth and many survivors face a lifetime of disability. The rates of
preterm births are rising in almost all countries and are associated with an
important financial burden to the society. The annual healthcare costs
associated with preterm births was estimated in 2005 at approximately 27 billion
USD in the USA. Costs after the neonatal period for lifetime medical & special
services reach more than 500 thousand USD per premature handicapped child.
Preterm labor is characterized by premature uterus contractions leading to birth
before 37 weeks.
About OBE001
OBE001 is a new generation oxytocin antagonist. Oxytocin antagonists are potent
inhibitors of uterine contractions. OBE001 is being developed for oral treatment
of preterm labor, between 32 to 36 weeks of gestation.
In addition to the TERM Phase 2 trial for preterm labor, OBE001 is also
currently being assessed in a separate Phase-3-enabling, Phase 2 clinical study
for improving embryo implantation and clinical pregnancy rates in women
undergoing in vitro fertilization (IVF)/intra-cytoplasmic sperm injection
(ICSI). For additional information about Assisted Reproductive Technology (ART)
and about OBE001, please visit www.ObsEva.com and see the press release dated
18 November 2014.
About ObsEva
ObsEva is a clinical stage biopharmaceutical company focusing on the development
of a novel generation of drugs addressing serious conditions compromising
pregnancy from conception to birth. Our lead programs target the underserved
problems of infertility and preterm labor affecting more and more women
worldwide. The ObsEva team's unique development expertise is supported by top-
tier investors in order to build a leading company in pregnancy pharmaceuticals.
www.ObsEva.com
For further information, please contact ObsEva CEO Office:
Delphine Renaud
Tel: +41 22 552 1550
Email: delphine.renaud(at)obseva.ch
Press release (PDF):
http://hugin.info/157613/R/1930276/693785.pdf
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Source: ObsEva SA via GlobeNewswire
[HUG#1930276]
Unternehmensinformation / Kurzprofil:
Datum: 23.06.2015 - 08:30 Uhr
Sprache: Deutsch
News-ID 402278
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