Oak Hill Bio Holdings and Chiesi Announce the Completion of Patient Enrollment in the Phase 2b Clinical Study Evaluating OHB-607 for the Prevention of Bronchopulmonary Dysplasia, a Leading Cause of Chronic Lung Disease in Premature Infants.
§ Completion of enrollment marks a significant milestone in evaluating OHB-607’s potential to prevent bronchopulmonary dysplasia (BPD), one of the most serious and common complications of extreme prematurity.
§ The successful enrollment of 352 infants across a global network of neonatal centers demonstrates the medical community's commitment to advancing innovative therapies for BPD, a condition with a significant unmet medical need.
§ Together, Oak Hill Bio Holdings and Chiesi are advancing OHB-607 as a potential first disease-modifying therapy for BPD prevention, reinforcing their shared commitment to improving outcomes for extremely premature infants and their families.
Boston (United States) and Parma (Italy), 30 June 2026 - Oak Hill Bio Holdings Ltd, a clinical-stage company specializing in neonatal and rare disease therapeutics and Chiesi Group, an international, research-driven biopharmaceutical group, have announced the completion of patient enrollment in the Phase 2b clinical study evaluating OHB-607 for the prevention of bronchopulmonary dysplasia (BPD), a leading cause of chronic lung disease in premature infants for which there are no approved therapies.
The FOOTPRINTS Phase 2b study enrolled 352 infants born between 23 and 28 weeks of gestation across North America, the United Kingdom, Europe, Japan, and Australia. Target enrollment increased from 338 to 352 following a recommendation from the Data Safety Monitoring Board, based on a prespecified, blinded sample-size re-evaluation. The study design has been published in BMJ Paediatrics Open[1].
“This milestone is a significant advancement in the development of OHB-607, an investigational therapy designed to restore physiologic insulin-like growth factor-1 (IGF-1) levels following extremely premature birth. The completion of enrollment in the FOOTPRINTS study is a remarkable achievement and reflects the dedication of our investigators, neonatal care teams, study coordinators, families, and Chiesi, our global development partner,“ said Dr. Victoria Niklas, Chief Medical Officer of Oak Hill Bio Holdings.
Chiesi Group, alongside Oak Hill Bio Holdings, highlights that the participation of 352 extremely premature infants and their families underscores the community's urgency to develop innovative therapies that address the enormous unmet medical need associated with the consequences of prematurity and improve outcomes for these infants. “The completion of enrollment brings us one step closer to understanding the potential of OHB-607 to improve the outcomes and make a meaningful difference for these highly vulnerable infants across their lifespan. We look forward to reporting topline results in early 2027,” said Oak Hill Bio Holdings and Chiesi Group.
Infants enrolled in the treatment arm received OHB-607 via continuous intravenous infusion within 24 hours of birth and continuing until 30 weeks post menstrual age (PMA), in addition to standard neonatal care. The primary endpoint of the study is the reduction in the incidence of severe BPD or mortality by 36 weeks PMA compared to extremely premature infants receiving standard neonatal care alone. The study will also evaluate the impact of OHB-607 on weaning from respiratory support through 12 months corrected age (CA), as a longer-term respiratory outcome measure, and assess its impact on other complications of prematurity. All infants in the study are followed for up to 24 months CA to capture the full safety and efficacy profile of OHB-607 and its impact on neurodevelopmental outcomes.
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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 growth and gestational development of vital organs, including the lungs, eyes, and brain. Mothers are the primary source of IGF-1 for the developing foetus until about 30 weeks of gestational age, when the foetal liver takes over. As a result, infants born before 28 weeks of gestation have low IGF-1 levels, which is believed to lead to organs failing to grow and develop normally.
Following preterm birth, IGF-1 levels decrease rapidly and remain low for the first weeks of life relative to corresponding foetal levels in utero. Longitudinal studies report an association between lower serum IGF-1 levels at birth in extremely preterm infants and an increased risk of BPD, retinopathy of prematurity, neurodevelopmental impairment, and overall growth impairment. This provides a rationale for evaluating OHB-607 to restore IGF-1 to levels present in utero in a full-term pregnancy, potentially supporting the normal growth and development of the lung and other organs.
OHB-607 has the potential to be the first major breakthrough in respiratory therapy for extremely preterm infants since lung surfactants were first approved more than 30 years ago.
About Bronchopulmonary Dysplasia (BPD)
BPD is the most common complication of prematurity, characterized by chronic lung disease in extremely preterm infants. Beyond its immediate impact on lung function, BPD can also lead to higher mortality rates, prolonged hospitalization, increased healthcare costs, as well as long-term respiratory morbidity and neurodevelopmental disability.
The pathogenesis of BPD is multifactorial and not fully understood, but gestational age remains the most critical factor in predicting the condition. Additional factors, including birth weight, growth restriction, lung function, and gender, may influence the severity of BPD. Infants requiring prolonged oxygen therapy or mechanical ventilation are at heightened risk, as these life-sustaining practices can cause direct and indirect damage to the developing lungs. OHB-607 represents a promising therapeutic advance, with the potential to support lung development and reduce reliance on intensive respiratory support. By addressing the root causes of lung injury, OHB-607 may help mitigate the severity of BPD and its associated long-term outcomes.
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About Oak Hill Bio Holdings
Oak Hill Bio Holdings Ltd (formerly known as Oak Hill Bio Ltd) is a neonatal and rare-disease therapeutics company developing life-changing medicines in neonatology and for patients with rare diseases. The company, with operations in the United States, the United Kingdom, and Europe, is advancing a pipeline of promising clinical-stage and preclinical investigational therapeutics. For more information, visit the company’s website at www.oakhillbioholdings.com.
About Chiesi Group
Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.
By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.
With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,000 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.
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Oak Hill Bio Holdings
Victoria Niklas, Chief Medical Officer
Chiesi Group
Anja Ivić, CARE Communications Manager
Contacts for Media:
[1] Baraldi E, de Luca D, Bonadies L, Kusuda S, Bancalari EH, Ramanathan R, Niklas V. A Randomised Phase 2b Trial of OHB 607 for Bronchopulmonary Dysplasia Prevention in Preterm Neonates: Study Protocol. BMJ Paediatrics Open. https://doi.org/10.1136/bmjpo-2025-004196.
