Mecasermin Rinfabate

Oak Hill Bio and Chiesi Group Announce Enrollment of First Patients in Australia and Japan 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. Multi-centre study, re-launched in May 2024, builds on prior Phase 2a clinical data[1], demonstrating a reduction in severe bronchopulmonary dysplasia (BPD). OHB-607 is being investigated as a potential breakthrough in the respiratory care of extremely preterm neonates.[2] Oak Hill Bio and Chiesi Group are advancing the development of OHB-607 through a strategic license and development partnership. Cambridge (United States) and Parma (Italy), March 13, 2026 - Oak Hill Bio, a clinical-stage company specializing in neonatology and rare disease therapeutics, and Chiesi, an international, research-driven biopharmaceutical group, have announced the enrolment of patients in Australia and Japan in their multinational Phase 2b clinical study evaluating the efficacy and safety of OHB-607. This investigational drug candidate aims at preventing severe complications in extremely premature infants, including bronchopulmonary dysplasia (BPD), a serious condition for which there are no approved therapies. The study is already enrolling patients in North America and the EU. “As advances in neonatal intensive care allow more extremely premature infants to survive to discharge, increasing numbers of infants are living with BPD, which remains the most common cause of chronic lung disease and the dominant complication of extreme prematurity,” said Dr. Victoria Niklas, Chief Medical Officer of Oak Hill Bio. “OHB-607 is designed to restore physiologic IGF-1 levels during a critical window of lung development, targeting pathways disrupted after extremely premature birth.” ‍ Neonatal Care in Australia and Japan The impact of our partnership in Australia is bolstered by national data from the Report of the Australian and New Zealand Neonatal Network (ANZNN) 2023[3], which shows that rates of BPD[3] among infants born before 32 weeks’ gestation have increased steadily over the past decade. The highest rates are reported in infants less than 26 weeks’ gestation, where BPD prevalence rose from approximately 78% in 2014 to nearly 90% in 2023, with rates in infants born between 26–28 weeks’ gestation increasing from around 40% to 50% over the same period. Neonatal Research Network of Japan Database highlights remarkable progress in the survival rates for infants born at 23-28 weeks of gestation, reaching nearly 90%[4]. However, about 50% of these infants develop BPD, with more than half experiencing severe forms of the condition. These facts underscore the urgent need for innovative therapeutic options like OHB-607. “The inclusion of Australian and Japanese patients in this study reflects the shared commitment of Chiesi and Oak Hill Bio to tackle urgent neonatal health challenges on a global scale,” said Diego Ardigò, Executive Vice President, Global Research & Development, Chiesi Group. “The high incidence of BPD in Australia and Japan highlights the critical need for innovative therapeutic solutions, and we believe addressing the medical needs of the most vulnerable patients is not only a scientific endeavour but also a moral responsibility”. ****** About the FOOTPRINTS Phase 2b Study The Phase 2b clinical study is a multinational, multicentre, randomized, open-label, two-arm study designed to evaluate the efficacy and safety of OHB-607 compared to standard neonatal care for preventing BPD and related complications in extremely preterm infants born between 23 and 28 weeks of gestation. The study, which opened in the United States in May 2024, is now enrolling patients in Australia. The study aims to recruit up to 338 patients globally, including North America, Europe, and Japan, and infants from Australia. OHB-607 will be administered via continuous intravenous infusion within 24 hours of birth, continuing until infants reach 30 weeks postmenstrual age, 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 postmenstrual age compared to extremely premature infants receiving standard neonatal care alone. The study will also evaluate the impact of OHB-607 on weaning from respiratory technology support through 12 months corrected age as a longer-term respiratory outcome measure, the impact on neurodevelopment, and the incidence of other complications of prematurity, including intraventricular haemorrhage (bleeding in the brain) and retinopathy of prematurity (vision impairment and blindness). The study will use a modified National Institute of Child Health and Human Development (NICHD) score to grade BPD severity, enabling comparison of infants with the most severe form of the disease. For additional information and to learn more about the trial registration, please visit https://clinicaltrials.gov/study/NCT03253263 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 the growth and gestational development of vital organs, including the lung, eye, and brain. Mothers are the primary source of IGF-1 for the developing foetus until about 30 weeks of gestational age, when the fetal 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 fetal 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 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[4]. 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)[5] 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[6],[7]. 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 complications. ****** About Oak Hill Bio Oak Hill Bio Ltd is a clinical-stage rare-disease therapeutics company developing life-changing medicines for extremely preterm infants and 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.oakhillbio.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. ****** Oak Hill Bio Victoria Niklas, Chief Medical Officer Chiesi Group Anja Ivic, CARE Communications Manager Contacts for Media: media@oakhillbio.com ‍ [1] Ley D, Hallberg B, Hansen-Pupp I, et al. rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial. J Pediatr. 2019;206:56-65.e8.doi:10.1016/j.jpeds.2018.10.033 [2] Owen, Louise S et al. The evolution of modern respiratory care for preterm infants. The Lancet, Volume 389, Issue 10079, 1649 – 1659. [3] Chow S, Creighton P, Holberton J.R., Chamers G.M., Lui K, Report of The Australian and New Zealand Neonatal Network. 2023, p. 33 BPD is referred to as Chronic Lung Disease (CLD) in the ANZNN report as the continued need for any form of respiratory support (supplemental oxygen and/or assisted ventilation) at 36 weeks post-menstrual age (PMA) [4] https://plaza.umin.ac.jp/nrndata/syukeie.htm [5] Kramer BW, Abman S, Daly M, et al. Insulin-like growth factor-1 replacement therapy after extremely premature birth: An opportunity to optimize lifelong lung health by preserving the natural sequence of lung development. Paediatr Resp Rev 2023 May 6:S1526-0542(23)00020-9 [6] Thébaud B, Goss KN, Laughon M, et al. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78 [7] Homan TD, Nayak RP. Short- and Long-Term Complications of Bronchopulmonary Dysplasia. Respir Care. 2021;66(10):1618-1629. doi:10.4187/respcare.08401 ‍