FDA Approves Key Step for Biologic to Treat Severe Lung Condition Affecting Preterm Infants

Post Date: April 1, 2021

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Airway Therapeutics’ AT-100 treatment for bronchopulmonary dysplasia (BPD) based on discoveries from researchers at Cincinnati Children’s

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Jeffrey Whitsett, MD

The U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application from Airway Therapeutics Inc. to develop AT-100 (rhSP-D) as a preventive treatment for BPD in very preterm babies.

Later this year, Airway plans to begin a Phase 1b clinical trial to evaluate the safety and tolerability of intratracheal administration of AT-100. If successful, a larger clinical trial would follow, with preliminary results expected as soon as second half 2023.

Airway Therapeutics was formed in June 2011 in part with funding support from CincyTech and the Cincinnati Children’s Tomorrow Fund.

The company’s product is based on years of research led by Jeffrey Whitsett, MD, a leading figure in pulmonary medicine research. Whitsett is chief of the Section of Neonatology, Perinatal and Pulmonary Biology, and co-director of the Perinatal Institute at Cincinnati Children’s.

Whitsett’s work includes cloning the genes for surfactant proteins A, B, C and D, and clarifying their roles in lung development and function. His work was central to the development of artificial surfactant, a treatment that has preserved lung function for a generation of preterm infants.

The investigational treatment AT-100 seeks to improve upon existing surfactant treatments by helping prevent a severe form of lung tissue inflammation that can occur among preterm infants relying on mechanical ventilation.

Whitsett remains involved with Airway, serving as chair of the company’s scientific advisory board. Cincinnati Children’s neonatologist Paul Kingma, MD, PhD, neonatal director at the Cincinnati Fetal Center and co-director of the Cincinnati Bronchopulmonary Dysplasia Center, is the company’s chief medical officer.

 

Read the Airway Therapeutics announcement

Explore related news and research:

View publications from the Whitsett lab

Modulating pulmonary inflammation, Feb. 2016,  Science, by Whitsett et al.

Cincinnati Enquirer, April 2014, Big Step Forward for Airway Therapeutics

The Molecular Era of Surfactant Biology, May 2014, Neonatology, by Jeffrey Whitsett, MD