• Design of the multi-center study is based on Phase 2a clinical data, which showed a decrease in the occurrence of severe bronchopulmonary dysplasia (BPD), a condition for which there are no approved therapies.
• OHB-607 has the potential to be the first innovative respiratory therapeutic advance for extremely preterm neonates in over thirty years.
• Oak Hill Bio and Chiesi Group are collaborating to develop OHB-607 under a license and development agreement.

CARY, N.C., May 17, 2024 /PRNewswire/ -- Oak Hill Bio, a clinical-stage neonatology and rare disease therapeutics company, and Chiesi, an international, research-focused biopharmaceutical group  (Chiesi Group), announced that the first patient has been enrolled in a resumed Phase 2b clinical study to assess the efficacy and safety of OHB-607, an investigational drug candidate being developed to treat complications of extremely premature birth, including bronchopulmonary dysplasia (BPD), a serious condition for which there are no approved therapies.

"As a neonatologist, I'm thrilled that we have restarted this groundbreaking clinical trial previously paused during the out-licensing process to Oak Hill Bio. OHB-607 can potentially improving the outcomes for infants born extremely premature," said Victoria Niklas, Chief Medical Officer at Oak Hill Bio. "At Oak Hill Bio, we are committed to advancing the field of neonatology and delivering the best possible care and outcomes to patients together with our partners at Chiesi." 

Diego Ardigò, Global research & Development Head at Chiesi Group said "Within the fragility of extreme prematurity lies a pressing need for action. With OHB-607, there is a chance to provide the babies with what they lack due to their immaturity. Addressing the medical needs of these infants goes beyond scientific inquiry; it's a moral imperative to safeguard their well-being."

About the Phase 2b Study

The Phase 2b clinical study is a multicenter, randomized, open-label, two-arm study designed to evaluate the efficacy and safety of OHB-607 compared to standard neonatal care for preventing BPD and other complications of prematurity among infants born extremely premature (between 23 and 28 weeks of gestation). The study will open at multiple centers across the US and shortly extend to Japan and Europe. It is designed to enroll at least 338 infants.

OHB-607 will be administered by continuous intravenous infusion from 24 hours after birth until 30 weeks postmenstrual age. All infants will simultaneously receive standard neonatal care based on the individual infant's condition and local guidelines.

The primary endpoint of the study is the reduction in the incidence of severe BPD or death by 36 weeks postmenstrual age compared to extremely premature infants receiving standard neonatal care alone. The study will also evaluate the impact of OHB-607 on weaning from respiratory technology support through 12 months corrected age as a longer-term respiratory outcome measure, the impact on neurodevelopment, and the incidence of other complications of prematurity, including intraventricular hemorrhage and retinopathy of prematurity. The study will utilize a modified National Institute of Child Health and Human Development (NICHD) score to define BPD severity grading, allowing the comparison of infants with the most severe form of the disease.

For additional information and to learn more about the trial registration, please visit https://clinicaltrials.gov/study/NCT03253263

About OHB-607 

OHB-607 is the recombinant form of human insulin-like growth factor-1 (IGF-1) complexed with its main binding protein (rhIGFBP-3). IGF-1 is a key driver of the growth and gestational development of vital organs, including the lung, eye, and brain. Mothers are the primary source of IGF-1 for the developing fetus until about 30 weeks gestational age, when the fetal liver takes over. As a result, infants born before 28 weeks of gestational age have low levels of IGF-1, which is believed to result in the failure of organs to grow and develop normally. A previous Phase 2a study demonstrated a decrease in severe BPD and the feasibility of OHB-607 infusion, supporting further investigation of OHB-607 for the prevention of complications of prematurity.

About Bronchopulmonary Dysplasia (BPD)

BPD is the most common complication of prematurity, resulting in chronic lung disease affecting 40-50% of infants born at less than 28 weeks of gestational age. BPD can lead to greater mortality, increased hospitalization, and cost burden, as well as long-term respiratory morbidity and neurodevelopment disability. 

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SOURCE Chiesi Group