In 2008, more than 530,000 babies were born prematurely in the U.S. That's about one in eight babies, according to the March of Dimes. Many have lungs that are not yet fully developed. That's where Airway Therapeutics
comes in - the local business was created to help premature infants with their lung development and even survival rates.
Based on ten years of research at Cincinnati Children's Hospital Medical Center, Airway Therapeutics was created to develop a surfactant protein that lines the surface and airways of babies' lungs to help inflate them and keep their air sacs from collapsing.
Airway's initial focus will be on the prevention of bronchopulmonary dysplasia (BPD) and also the prevention and treatment of neonatal respiratory distress syndrome (nRDS) in very premature infants. Normally, lungs mature to produce surfactant in the seventh month of gestation. Very premature infants (before 32 weeks gestation) have generally not developed lung surfactant to make the transition during birth from fluid-filled lungs to lungs that can easily expand to handle air movement. Administering surfactant to these very premature infants shortly after birth allows them to breathe.
Airway's product, rhSP-D, would be added to existing surfactant prior to treating a premature newborn, and has been shown in the lab of Dr. Jeffrey Whitsett to be useful in reducing lung inflammation, a condition associated with BPD. Dr. Whitsett is chief of the Section of Neonatology, and Perinatal and Pulmonary Biology at Children's. Bringing his research into the market is CEO Steve Linberg, Ph.D., who has more than 30 years of clinical research, drug development and biologic development experience.
The company recently received a seed-stage investment by CincyTech
- a Cincinnati-based venture development firm that invests in technology-based startup companies - and the Cincinnati Children's Tomorrow Fund. Each has invested $250,000 as part of a projected $1.2 million seed-stage funding round led by CincyTech. The company is headquartered at BioStart
, the Cincinnati bioscience startup center located in Clifton, which is a previous investor in Airway.
The new investment will allow Airway to meet with the Food and Drug Administration within a few months to confirm their plans to begin developing rhSP-D in combination with an already-available surfactant, and then file an Investigational New Drug (IND) application within 15 months. Linberg estimates a total estimated cost of $25 million to bring the drug to market.
"This drug will save babies that don't survive today and radically improve the lives of millions of others," says CincyTech Executive-in-Residence Mike Venerable.
Writer: Sarah Blazak