Oak Hill Bio and Chiesi Group have extended their Phase IIb clinical trial of OHB-607 to Europe, enrolling the first European patient. This collaborative effort aims to prevent bronchopulmonary dysplasia (BPD) and other prematurity-related complications in extremely premature infants.
The open-label, multi-center, randomized, two-arm trial will evaluate OHB-607's efficacy against standard neonatal care in infants born between 23 and 28 weeks of gestation. Having commenced in the US in May 2024, the trial now includes sites in Europe and Japan, targeting a total enrollment of at least 105 infants across countries such as Germany, Finland, Ireland, Netherlands, Italy, Portugal, Spain, and the UK.
OHB-607: Mechanism and Administration
OHB-607 is a recombinant form of human insulin-like growth factor-1 (IGF-1), complexed with its primary binding protein. It is designed to bolster the development of critical organs in premature infants. The drug will be administered via continuous intravenous infusion starting 24 hours after birth and continuing until the infant reaches 30 weeks postmenstrual age, in conjunction with standard care tailored to each infant's specific needs.
Trial Endpoints and Assessments
The trial's primary endpoint is to assess the reduction in severe BPD incidence or death by 36 weeks postmenstrual age. Secondary endpoints include evaluating the impact of OHB-607 on weaning from respiratory support by 12 months corrected age, neurodevelopmental outcomes, and the incidence of other prematurity complications, such as retinopathy of prematurity and intraventricular hemorrhage. BPD severity will be graded using a modified score from the National Institute of Child Health and Human Development (NICHD).
Leadership Perspective
Chiesi Group global research and development executive vice-president Diego Ardigò stated, "The restart of this study marks a significant milestone highlighting the shared commitment of Chiesi and Oak Hill Bio to advance solutions for the vulnerable group of extremely premature infants, now including patients from Europe."
