Chiesi Group and Oak Hill Bio announce License and Development Agreement to develop, manufacture, and commercialise OHB-607, a potentially transformative neonatal therapy

• Chiesi Group and Oak Hill Bio will collaborate closely to develop OHB-607, a clinical-stage investigational drug candidate being developed to treat complications of extremely premature birth.
• This agreement expands Chiesi’s commitment to Neonatology, a highly strategic area for the company.
• Partners intend to continue Phase 2b clinical trial of OHB-607 in 2024.

MANCHESTER, UK, 9^th January 2024 – Chiesi Farmaceutici S.p.A (“Chiesi Group”), an international, research-focused biopharmaceuticals and healthcare group, and Oak Hill Bio, a clinical-stage neonatology and rare disease therapeutics company, today announced the execution of a License and Development Agreement to develop, manufacture, and commercialise OHB-607, an investigational drug candidate being developed to treat complications of extremely premature birth.

OHB-607 is a recombinant version of insulin-like growth factor-1 (IGF-1), a key driver of foetal growth and development, and its binding protein, IGFBP-3. For the developing foetus, mothers are the primary source of IGF-1. Babies born at less than 28 weeks gestational age have low levels of IGF-1 and face high risk of severe bronchopulmonary dysplasia (BPD), which may lead to chronic lung disease. There are currently no approved medicines to prevent BPD in pre-term infants. OHB-607, a human IGF-1 replacement, is designed to help prevent BPD and its long-term respiratory consequences. 

“BPD represents a challenging complication of prematurity for which there is currently no available treatment. Innovative solutions are needed, and the therapy may provide a solution for a disease with one of the highest unmet medical needs in the field of neonatology,” commented Ralph Blom, General Manager, Chiesi UK and Ireland.

Chiesi and Oak Hill Bio intend to continue a Phase 2b clinical trial in 2024 in the United States, Europe, and Japan. Clinical studies conducted to date have demonstrated OHB-607’s potential to significantly reduce the risk of severe BPD.¹

“We hope that OHB-607 will lead to improved outcomes for extremely preterm infants at risk of severe BPD and subsequently chronic lung disease,” said Josh Distler, President, and Chief Financial Officer of Oak Hill Bio. “We are thrilled to partner with Chiesi. Their deep expertise in neonatology will help to rapidly advance this promising therapy to patients.”

Guggenheim Securities LLC acted as exclusive financial advisor to Oak Hill Bio and Goodwin Procter LLP served as its legal advisor.