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, 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 restart Phase 2b clinical trial of OHB-607 in 2024.

PARMA, Italy and CAMBRIDGE, Mass., Jan. 9, 2024 /PRNewswire/ -- 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 an 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 fetal growth and development, and its binding protein, IGFBP-3. 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 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.  

"Targeting a challenging complication of prematurity with an innovative solution is an important step given the potential benefits it may bring to the babies born extremely prematurely" commented Giuseppe Accogli, CEO of Chiesi Group. "This potentially transformative therapy may provide a breakthrough solution for bronchopulmonary dysplasia, one of the diseases with the highest unmet medical needs in the field of neonatology."

Chiesi and Oak Hill Bio intend to restart 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.

"We believe that OHB-607 has the potential to be the first major therapeutic breakthrough for extremely preterm infants since lung surfactants were first approved more than 30 years ago," 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."