Chiesi Enters Licensing Agreement with Oak Hill Bio for Neonatal Therapy

Rare Daily Staff

Chiesi Farmaceutici has entered into a license and development agreement with Oak Hill Bio for its experimental therapy to treat complications of extremely premature birth.

Bronchopulmonary dysplasia (BPD) is a form of chronic lung disease affecting newborns who are born prematurely, particularly those who are exposed to oxygen therapy or to use of breathing machine for a long time. Due to their immaturity, the lungs of premature newborns are particularly vulnerable and may undergo abnormal development in the postnatal period; in particular, high amounts of inhaled oxygen and pressure may overstretch the alveoli, causing inflammation and damage to the inside lining of the airways, the alveoli and the blood vessels around them.

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. For the developing fetus, 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, 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 for Chiesi, given the potential benefits it may bring to the babies born extremely prematurely,” said 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 plan 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.

Photo: Giuseppe Accogli, CEO of Chiesi Group