Oak Hill Bio and Chiesi Group have announced the enrollment of the first patient in a resumed Phase 2b clinical trial for OHB-607, an investigational drug aimed at treating complications arising from extremely premature birth, including bronchopulmonary dysplasia (BPD). This significant milestone marks a renewed effort to address a condition with no currently approved therapies.
About OHB-607
OHB-607 is a recombinant form of human insulin-like growth factor-1 (IGF-1) complexed with its main binding protein (rhIGFBP-3). IGF-1 is crucial for the growth and development of vital organs during gestation. Extremely premature infants, particularly those born before 28 weeks, typically have low levels of IGF-1, which can lead to inadequate organ development and complications like BPD. The investigational therapy aims to restore IGF-1 levels to support normal lung development, potentially reducing the incidence and severity of BPD .
Details of the Phase 2b Study
The multicenter, randomized, open-label study will compare the efficacy and safety of OHB-607 against standard neonatal care in infants born between 23 and 28 weeks of gestation. It is set to enroll at least 338 infants across multiple centers in the United States, Japan, and Europe. The primary endpoint is the reduction in severe BPD or death by 36 weeks postmenstrual age. Secondary endpoints include the impact on long-term respiratory outcomes and neurodevelopment.
About Bronchopulmonary Dysplasia
BPD is a chronic lung disease most common in premature infants who require extended oxygen therapy or mechanical ventilation. Affecting 40-50% of infants born before 28 weeks, BPD can lead to increased mortality, prolonged hospital stays, and long-term respiratory and neurodevelopmental issues. Current treatment strategies are limited and primarily supportive, highlighting the urgent need for effective therapies like OHB-607.
Companies Involved
Oak Hill Bio is a clinical-stage company focused on neonatology and rare diseases, committed to developing life-changing treatments for extremely preterm infants and other patients. Chiesi Group, an international biopharmaceutical company, has a strong emphasis on respiratory health, rare diseases, and specialty care. Their collaboration leverages Chiesi’s expertise in neonatology and Oak Hill Bio’s innovative approach to address unmet medical needs.
The Biosimilars Market
The biosimilars market, including drugs like OHB-607, is expected to grow significantly. In 2023, the market was valued at approximately $29.51 billion and is projected to reach $108.8 billion by 2031, driven by the increasing prevalence of chronic diseases, rising healthcare costs, and the need for cost-effective therapies.
This collaboration between Oak Hill Bio and Chiesi Group represents a promising advancement in the treatment of bronchopulmonary dysplasia, potentially providing a much-needed therapeutic option for extremely premature infants. The ongoing Phase 2b study will be crucial in determining the future of OHB-607 and its role in neonatal care.
