GSK premature babies drug starts late-stage trials
pharmafile | March 18, 2015 | News story | Sales and Marketing | GSK, Retosiban, atosiban, babies, birth, oxytocin, premature
GlaxoSmithKline has initiated Phase III studies to evaluate the safety and efficacy of an investigational treatment for babies born prematurely.
Retosiban is an oxytocin – a brain hormone – antagonist in development as a potential therapy to improve neonatal outcomes of babies born to women in spontaneous preterm labour, by prolonging the time to delivery.
The study will compare GSK’s experimental drug with atosiban, another hormone antagonist indicated to delay premature birth. The primary outcome measure of this study is the time to delivery after the start of treatment.
“Preterm birth is a leading cause of illness and death in newborns and infants worldwide. As part of our efforts to address this issue, we are evaluating whether retosiban can potentially stop preterm labour and whether increasing the gestational age of a newborn baby can reduce the complications of prematurity,” explains Pauline Williams, who is the vice president and head of GSK’s maternal and neonatal health unit.
The key secondary endpoints will measure neonatal morbidities and mortality, and a follow-up study will assess the long-term outcomes of infants born to mothers participating in the studies.
Retosiban is thought to work by blocking the effects of oxytocin, a hormone produced by the body during labour – in order to stop preterm labour and thereby increase gestational age at birth.
Globally an estimated 15 million babies are born prematurely every year, and is the leading cause of death among children under five years of age. According to the World Health Organization, preterm labour was responsible for nearly one million deaths in 2013.
Multiple pregnancies, infections and chronic conditions – such as diabetes and high blood pressure – are often the most common causes of the complication during birth. More than 60% of preterm births occur in Africa and South Asia, within these countries, poorer families are at higher risk.
Tom Robinson
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