Oak Hill Bio and Chiesi Enroll First European Patient in Phase 2b Study of OHB-607 to Prevent Bronchopulmonary Dysplasia in Preemies

Oak Hill Bio, a company focused on neonatology and rare disease therapeutics, in collaboration with Chiesi, an international biopharmaceutical firm, has announced the enrollment of the first European patient in their Phase 2b clinical trial. This study, which resumed in May, aims to evaluate the effectiveness and safety of OHB-607, an investigational drug intended to prevent complications related to extremely premature births, including bronchopulmonary dysplasia (BPD). BPD is a severe lung condition for which there are currently no approved treatments.

Victoria Niklas, Chief Medical Officer at Oak Hill Bio, expressed her excitement about the continuation of this crucial clinical trial, which was previously paused. She emphasized the potential of OHB-607 to improve outcomes for infants born extremely prematurely. Niklas highlighted the company's commitment to advancing neonatology and providing the best possible care in partnership with Chiesi.

Diego Ardigò, Executive Vice President of Global Research & Development at Chiesi Group, noted that the restart of this study is a significant milestone. He underscored the shared commitment of Chiesi and Oak Hill Bio to finding solutions for extremely premature infants, including those from Europe, stating that addressing the needs of these vulnerable infants is both a scientific and moral obligation.

The Phase 2b clinical trial is a multicenter, randomized, open-label, two-arm study. It aims to compare the efficacy and safety of OHB-607 with standard neonatal care in preventing BPD and other complications in infants born between 23 and 28 weeks of gestation. Initially launched in the United States, the study is now expanding to Europe, including countries such as Finland, Germany, Ireland, Italy, Netherlands, Portugal, Spain, and the UK, as well as Japan. The study plans to enroll at least 105 infants in Europe.

OHB-607 will be administered through continuous intravenous infusion starting 24 hours after birth until the infants reach 30 weeks postmenstrual age. All participants will also receive standard neonatal care based on individual needs 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 standard care alone. The study will also assess the drug's impact on weaning from respiratory support up to 12 months corrected age, its effect on neurodevelopment, and the occurrence of other prematurity-related complications like intraventricular hemorrhage and retinopathy of prematurity. The severity of BPD will be classified 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) complexed with its binding protein (rhIGFBP-3). IGF-1 is crucial for the growth and development of vital organs, including the lungs, eyes, and brain. Infants born before 28 weeks of gestational age typically have low levels of IGF-1, which can hinder normal organ development. Studies have linked low IGF-1 levels at birth in extremely preterm infants with an increased risk of BPD, retinopathy of prematurity, neurodevelopmental issues, and overall growth impairment. Therefore, OHB-607 aims to restore IGF-1 levels to those found in a full-term pregnancy, potentially supporting the normal growth and development of critical organs.

OHB-607 represents a potential breakthrough in respiratory therapeutics for extremely preterm infants since lung surfactants were first approved over 30 years ago. BPD remains the most common complication of prematurity, affecting 40-50% of infants born before 28 weeks of gestation. It not only impacts lung function but also increases mortality, hospitalization rates, and long-term respiratory and neurodevelopmental issues. The study aims to show that OHB-607 can promote lung development and reduce the need for respiratory support, potentially lessening the severity of BPD and its long-term consequences.

Oak Hill Bio is dedicated to developing transformative medicines for extremely preterm infants and patients with rare autoimmune diseases. The company operates in the United States and the United Kingdom, advancing a pipeline of six promising clinical-stage and preclinical therapeutics. Chiesi Group, with a mission to improve quality of life and environmental responsibility, has a global presence and over 7,000 employees. Their extensive research and development efforts are focused on respiratory health, rare diseases, and specialty care.