The trial will assess the safety and efficacy of OHB-607 versus standard neonatal care to prevent BPD and other complications linked to premature birth. Credit: Vad-Len / Shutterstock.com.

Oak Hill Bio and Chiesi Group have announced the enrolment of the first subject in the resumed Phase IIb clinical study of OHB-607, aimed at preventing bronchopulmonary dysplasia (BPD) in premature infants.

The randomised, multicentre, open-label, two-arm trial will assess the safety and efficacy of OHB-607 compared to standard neonatal care to prevent BPD and other complications linked to premature birth.

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It will enrol a minimum of 338 extremely premature infants aged between 23 and 28 weeks of gestation.

The study will be conducted across multiple sites in the US and is expected to extend to Japan and European countries soon.

OHB-607, a recombinant form of human insulin-like growth factor-1 complexed with its main binding protein, will be administered via continuous intravenous infusion from 24 hours after birth until 30 weeks postmenstrual age.

All infants will be given standard neonatal care tailored to their individual needs and according to local guidelines.

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The decline in the occurrence of severe BPD or death by 36 weeks postmenstrual age, versus infants receiving only standard neonatal care will be the trial’s primary endpoint.

Additionally, the trial will assess the impact of OHB-607 on weaning from respiratory technology support up to 12 months corrected age, as well as its effects on neurodevelopment and the incidence of other complications of prematurity.

A previous Phase IIa study indicated a decline in severe BPD and confirmed the feasibility of administering OHB-607 infusion.

Chiesi Group Global Research & Development head 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.

“Addressing the medical needs of these infants goes beyond scientific inquiry; it’s a moral imperative to safeguard their well-being.”