GlaxoSmithKline’s premature babies drug begins phase III trials

GlaxoSmithKline (GSK) has started phase III trials to evaluate the efficacy and safety of retosiban, a potential treatment for babies that are born preterm.

The drug is an oxytocin antagonist in development as a possible therapy to improve neonatal outcomes of infants born prematurely by prolonging the time to delivery.

During the late-stage trials, experimental retosiban will be compared to atosiban, which is another hormone antagonist indicated to delay premature births. The primary outcome measure of this study is how many minutes elapse between taking the drug and the baby being born.

Pauline Williams, who is the vice-president and head of GSK’s maternal and neonatal health unit, commented: "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."

In addition, the secondary endpoints of the study will measure neonatal morbidities and mortality, while follow-up research will assess the long-term outcomes of infants born to the mothers that participated in the trials.  

Around 15 million babies across the globe are born prematurely every year and it is the leading cause of death among children under five years of age.