Chiesi and Oak Hill enroll first European patient in phase 2b preterm birth study

Chiesi Group and Oak Hill Bio have recently announced that the initial European patient has been enrolled in a Phase 2b trial assessing a drug candidate intended to prevent complications in extremely premature births.

This open-label study, which was relaunched in the United States in May, aims to evaluate the efficacy and safety of OHB-607 compared to standard neonatal care for preventing conditions such as bronchopulmonary dysplasia (BPD) and other complications in infants born between 23 and 28 weeks of gestation.

BPD is a significant concern, affecting up to 50% of infants born before 28 weeks of gestational age. This condition impacts lung function and is associated with higher mortality rates, extended hospital stays, long-term respiratory issues, and neurodevelopmental disabilities.

OHB-607 is a recombinant form of human insulin-like growth factor-1 (IGF-1), critical for the growth and development of vital organs. It is complexed with its main binding protein and has already shown promise in a Phase 2a trial for reducing severe BPD occurrences.

Typically, mothers are the primary source of IGF-1 until around 30 weeks of gestational age. Research indicates that lower serum IGF-1 levels at birth in extremely preterm infants are linked to a higher risk of BPD, retinopathy of prematurity, neurodevelopmental issues, and overall growth impairment.

In this study, which plans to enroll at least 105 infants in Europe, OHB-607 will be provided through continuous intravenous infusion from 24 hours after birth until 30 weeks post-menstrual age, with all infants also receiving standard neonatal care.

Diego Ardigò, Executive Vice President of Global Research and Development at Chiesi, emphasized the significance of this study's restart, stating that it represents a major milestone and highlights Chiesi and Oak Hill Bio's shared commitment to advancing solutions for extremely premature infants, now including those in Europe. Ardigò stressed the importance of addressing the medical needs of these infants not only as a scientific pursuit but as a moral obligation to ensure their well-being.

Victoria Niklas, Chief Medical Officer at Oak Hill Bio, shared similar enthusiasm. As a neonatologist, she expressed excitement about the restart of this pioneering clinical trial, highlighting the potential of OHB-607 to improve outcomes for infants born extremely premature.

Through this collaborative effort, Chiesi Group and Oak Hill Bio are taking significant steps to address a critical gap in neonatal care. The success of this trial could pave the way for new treatments that significantly enhance the survival and health outcomes of extremely premature infants, offering hope to many families worldwide.