- Pressemitteilung BoxID 543957
ObsEva Announces Recruitment of the First Patient in TERM Phase 2 Study
Clinical Trial to Evaluate the Safety and Efficacy of OBE001 for Delaying Spontaneous Preterm Labor in Pregnant Women
"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.
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.
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.
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
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