Pharma Focus America

Oak Hill Bio and Chiesi Group Announce Enrollment of First Patient in Phase 2b Study Resuming OHB-607 for Prevention of Bronchopulmonary Dysplasia in Premature Infants

Saturday, May 18, 2024

Oak Hill Bio, a clinical-stage company specializing in neonatology and rare disease therapeutics, in collaboration with Chiesi Group, a research-focused biopharmaceutical organization, has announced the enrollment of the first patient in their resumed Phase 2b clinical study of OHB-607. This investigational drug is aimed at addressing complications from extremely premature births, particularly bronchopulmonary dysplasia (BPD), a severe condition with no current approved treatments.

"As a neonatologist, I am thrilled to restart this groundbreaking clinical trial, which had been paused during the out-licensing process to Oak Hill Bio," said Victoria Niklas, Chief Medical Officer at Oak Hill Bio. "OHB-607 holds the potential to significantly improve outcomes for extremely premature infants. At Oak Hill Bio, our goal is to advance neonatology and provide the best possible care and outcomes to patients, in collaboration with Chiesi."

Diego Ardigò, Global Head of Research & Development at Chiesi Group, remarked, "The urgency of addressing extreme prematurity cannot be overstated. OHB-607 offers a chance to supply essential support to these vulnerable infants, addressing their unmet medical needs. Our commitment goes beyond scientific research; it is a moral duty to ensure their well-being."

The Phase 2b study is a multicenter, randomized, open-label, two-arm trial aimed at evaluating the efficacy and safety of OHB-607 compared to standard neonatal care. It focuses on preventing BPD and other complications in infants born between 23 and 28 weeks of gestation. The study plans to enroll at least 338 infants and will be conducted at multiple centers across the US, with future expansion to Japan and Europe.

OHB-607 will be given through continuous intravenous infusion starting 24 hours after birth until 30 weeks postmenstrual age. All infants will also receive standard neonatal care tailored to their specific conditions and local guidelines.

The primary goal is to reduce the incidence of severe BPD or death by 36 weeks postmenstrual age compared to infants receiving only standard neonatal care. The study will also examine the effects of OHB-607 on the duration of respiratory support up to 12 months corrected age, neurodevelopmental outcomes, and the incidence of other prematurity-related complications such as intraventricular hemorrhage and retinopathy of prematurity. BPD severity will be graded using a modified National Institute of Child Health and Human Development (NICHD) score.

OHB-607 is a recombinant form of human insulin-like growth factor-1 (IGF-1) combined with its main binding protein (rhIGFBP-3). IGF-1 is essential for the development of vital organs like the lungs, eyes, and brain. The primary source of IGF-1 for the fetus is the mother until around 30 weeks of gestation, after which the fetal liver takes over. Infants born before 28 weeks have low levels of IGF-1, leading to impaired organ development. A previous Phase 2a study indicated that OHB-607 could reduce severe BPD and supported the feasibility of its infusion, prompting further investigation.

BPD is the most frequent complication of prematurity, affecting 40-50% of infants born before 28 weeks of gestation. It leads to chronic lung disease, which increases mortality, hospitalization duration, medical costs, and long-term respiratory and neurodevelopmental issues.



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