Pharma Focus America

Chiesi Group and Oak Hill Bio Partner for Neonatal Therapy OHB-607 Development and Commercialization

Wednesday, January 10, 2024

Chiesi Farmaceutici S.p.A ("Chiesi Group") and Oak Hill Bio, a clinical-stage neonatology and rare disease therapeutics company, have entered into a License and Development Agreement to collaborate on the development, manufacturing, and commercialization of OHB-607. This investigational drug candidate aims to address complications associated with extremely premature birth.

OHB-607 is a recombinant version of insulin-like growth factor-1 (IGF-1), a crucial factor for fetal growth and development, along with its binding protein, IGFBP-3. Babies born at less than 28 weeks gestational age often have low levels of IGF-1, putting them at a high risk of severe bronchopulmonary dysplasia (BPD) and chronic lung disease. Currently, there are no approved medications to prevent BPD in preterm infants. OHB-607, designed as a human IGF-1 replacement, aims to prevent BPD and its long-term respiratory consequences.

Giuseppe Accogli, CEO of Chiesi Group, emphasized the significance of addressing the challenges of prematurity with an innovative solution, potentially offering breakthrough benefits for extremely premature infants.

Chiesi and Oak Hill Bio plan to resume a Phase 2b clinical trial for OHB-607 in 2024, spanning the United States, Europe, and Japan. Previous clinical studies have shown the drug's potential to significantly reduce the risk of severe BPD.

Josh Distler, President, and Chief Financial Officer of Oak Hill Bio, expressed optimism, calling OHB-607 a potential groundbreaking therapy for extremely preterm infants. The partnership with Chiesi, known for its expertise in neonatology, is expected to expedite the advancement of this promising therapy.

Bronchopulmonary Dysplasia (BPD) is a chronic lung disease affecting premature newborns, particularly those exposed to prolonged oxygen therapy or the use of a breathing machine. OHB-607 targets this condition by restoring IGF-1 levels critical for lung development.

BPD primarily affects infants born more than 10 weeks early, weighing less than two pounds at birth, and facing breathing problems. OHB-607 aims to address the significant unmet medical needs in neonatology, potentially reducing mortality rates, hospitalization periods, and long-term respiratory morbidity in extremely preterm infants.



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