OHB-607 is the recombinant form of human IGF-1, intended to support the development of vital organs in premature infants. Credit: BlueBoeing/Shutterstock.

Oak Hill Bio and Chiesi Group have enrolled the first European patient in a Phase IIb clinical study for their collaborative drug, OHB-607, to prevent bronchopulmonary dysplasia (BPD) in extremely premature infants.

The open-label, multi-centre, randomised, two-arm trial will compare the drug’s performance against regular neonatal care to prevent BPD and other prematurity complications in infants born between 23 and 28 weeks of gestation.

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The study, which commenced in the US in May 2024, is now extending to Europe and Japan.

It aims to enrol at least 105 infants across several European countries, including Germany, Finland, Ireland, Netherlands, Italy, Portugal, Spain, and the UK.

OHB-607 is the recombinant human insulin-like growth factor-1 (IGF-1) form, complexed with its primary binding protein, intended to support the development of vital organs in premature infants.

It will be administered through continuous intravenous infusion 24 hours after birth until the infant reaches 30 weeks postmenstrual age, alongside standard care tailored to each infant’s needs.

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The study’s primary endpoint is to assess the reduction in severe BPD incidence or death by 36 weeks postmenstrual age.

This trial will also assess the drug’s impact 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 haemorrhage.

It will use a modified score from the National Institute of Child Health and Human Development (NICHD) to grade BPD severity.

Chiesi Group global research and development executive vice-president Diego Ardigò said: “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.”