Chiesi Group and Oak Hill Bio have announced that the first European patient has been enrolled in a phase 2b study evaluating a drug candidate for preventing complications of extremely premature birth.
The open-label trial, re-launched in the US in May, is comparing the efficacy and safety of OHB-607 against standard neonatal care for preventing bronchopulmonary dysplasia (BPD) and other complications of prematurity among infants born between 23 and 28 weeks of gestation.
There are currently no approved therapies for BPD, which affects up to 50% of infants born at less than 28 weeks of gestational age. The condition has a direct impact on lung function and is associated with greater mortality, increased hospitalisation, as well as long-term respiratory morbidity and neurodevelopment disability.
OHB-607 is the recombinant form of human insulin-like growth factor-1 (IGF-1), a key driver of the growth and gestational development of vital organs, complexed with its main binding protein, and has already been shown in a phase 2a trial to decrease the occurrence of severe BPD.
Mothers are the primary source of IGF-1 until about 30 weeks gestational age, and research has shown a link between lower serum IGF-1 levels at birth in extremely preterm infants and an increased risk of BPD, retinopathy of prematurity, neurodevelopmental and overall growth impairment.
In the study, which is aiming to enrol at least 105 infants in Europe, OHB-607 will be administered by 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, global research and development at Chiesi, 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. Addressing the medical needs of these infants goes beyond scientific inquiry; it’s a moral imperative to safeguard their well-being.”
Sharing a similar sentiment, Victoria Niklas, chief medical officer at Oak Hill Bio, said: “As a neonatologist, I’m thrilled that we have restarted this groundbreaking clinical trial… OHB-607 can potentially improve outcomes for infants born extremely premature.”