First Patient Enrolled in Resumed Phase 2b OHB-607 Study for Preventing Bronchopulmonary Dysplasia in Preemies

Oak Hill Bio and Chiesi Group have announced the enrollment of the first patient in a resumed Phase 2b clinical study for OHB-607, an investigational drug aimed at treating complications in extremely premature infants, including bronchopulmonary dysplasia (BPD). This clinical trial marks a significant milestone as there are currently no approved therapies for BPD, a serious condition affecting premature infants' lungs.

Oak Hill Bio, a company dedicated to neonatology and rare disease therapeutics, and Chiesi Group, an international biopharmaceutical company, are collaborating under a license and development agreement to bring OHB-607 to fruition. The Phase 2b clinical study aims to evaluate the drug’s efficacy and safety compared to standard neonatal care.

The study is structured as a multicenter, randomized, open-label, two-arm trial. Its primary goal is to reduce the incidence of severe BPD or death by the time the infant reaches 36 weeks postmenstrual age. Secondary objectives include assessing the drug's impact on the ability of infants to wean from respiratory support by 12 months corrected age, its effect on neurodevelopment, and the frequency of other prematurity-related complications like intraventricular hemorrhage and retinopathy of prematurity. The study will use a modified National Institute of Child Health and Human Development (NICHD) score to grade the severity of BPD.

OHB-607, a recombinant form of human insulin-like growth factor-1 (IGF-1) complexed with its main binding protein, is designed to support the growth and development of vital organs in extremely premature infants. IGF-1 is crucial for the development of the lungs, eyes, and brain, and is typically provided by the mother until around 30 weeks of gestation. Infants born before 28 weeks often have low levels of IGF-1, leading to underdeveloped organs. A prior Phase 2a study indicated that OHB-607 could reduce severe BPD and showed the feasibility of its continuous intravenous infusion, which will be administered from 24 hours after birth until 30 weeks postmenstrual age.

Dr. Victoria Niklas, Chief Medical Officer at Oak Hill Bio, expressed her enthusiasm about restarting this pivotal clinical trial, which had been paused during the out-licensing process. She emphasized Oak Hill Bio's commitment to improving outcomes for extremely premature infants through advanced treatments. Diego Ardigò, Global Research & Development Head at Chiesi Group, highlighted the pressing need to address the medical challenges faced by these vulnerable infants, viewing it as both a scientific and moral imperative.

The study will initially roll out in multiple centers across the United States and will soon extend to Japan and Europe. It aims to enroll at least 338 infants. All participating infants will receive standard neonatal care along with the investigational drug.

BPD remains the most prevalent complication of extreme prematurity, affecting 40-50% of infants born before 28 weeks of gestation. The condition leads to chronic lung disease, increased mortality, prolonged hospitalization, and long-term respiratory and neurodevelopmental issues. As such, the successful development of OHB-607 could mark a groundbreaking advancement in neonatal care, potentially offering the first innovative respiratory therapeutic for extremely preterm neonates in over three decades.

In summary, the collaborative effort between Oak Hill Bio and Chiesi Group to develop OHB-607 represents a beacon of hope for addressing the critical health challenges faced by extremely premature infants. The ongoing Phase 2b study will be crucial in determining the drug's potential to improve outcomes for this vulnerable population.