Airway Therapeutics LLC has been created to commercialize pulmonary therapy research developed at Cincinnati Children's Hospital Medical Center and has received a $500,000 investment from CincyTech and Cincinnati Children's Tomorrow Fund.
The investments are part of a projected $1.2 million seed-stage funding round led by CincyTech.
CincyTech and the Tomorrow Fund each invested $250,000 in the company, which is developing a new surfactant protein that would significantly improve lung function in premature infants. The company is headquartered at BioStart, the Cincinnati bioscience startup center located in Clifton, which is a previous investor in Airway.
Airway's recombinant human surfactant protein D technology (rhSP-D) is based on 10 years of research by Jeffrey Whitsett, M.D., at Cincinnati Children's. Dr. Whitsett is chief of the Section of Neonatology, Perinatal and Pulmonary Biology at Children's and one of Children's most prolific researchers.
The company is run by CEO Steve Linberg, Ph.D., who has more than 30 years of clinical research, drug development and biologic development experience.
Airway's initial focus will be on the prevention of bronchopulmonary dysplasia (BPD) in conjunction with the prevention and treatment of neonatal respiratory distress syndrome (nRDS) and 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 yet 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 these infants to breathe. Currently there are three companies marketing surfactant in the U.S. for nRDS, but none is approved for BPD.
Surfactant Protein D is a normal component of animal (including human) surfactant but is missing in the available surfactants. Airway's product, rhSP-D, would be added to existing surfactant prior to treating the very premature newborn, and has been shown in Dr. Whitsett's lab to be useful in reducing lung inflammation, a condition associated with BPD.
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.
"The company is already in discussion with one of the three surfactant manufacturers as a potential partner to produce the proposed new rhSP-D combination surfactant for use in treating these very premature infants," Linberg said.
It is estimated that it will cost about $25 million to take the new combination product for the prevention of BPD in premature infants to market. Future goals include combining rhSP-D with a separate inhaled surfactant for the treatment for cystic fibrosis.
CincyTech Executive-in-Residence Mike Venerable says Airway has the potential to bring to market a treatment that can save lives and improve child health.
"Within the U.S., it's estimated that between 5,000 and 10,000 newborns develop bronchopulmonary dysplasia each year," said Venerable. "rhSP-D will save babies that don't survive today and radically improve the lives of millions of others."
About Airway Therapeutics
Airway Therapeutics LLC was created to develop novel surfactant products based on 10 years of research conducted by Dr. Jeffrey Whitsett at Cincinnati Children's Hospital Medical Center. The initial target applications include bronchopulmonary dysplasia (BPD) in premature infants and cystic fibrosis.
CincyTech is a public-private venture development organization that invests in startup businesses in high-tech industries in Southwest Ohio. With substantial support from Ohio Third Frontier and corporations, foundations, civic organizations and individuals here, it is stimulating the growth of venture-worthy companies in information technology, bioscience and advanced manufacturing.
Steven E. Linberg, Ph.D.
Airway Therapeutics LLC
Carolyn Pione Micheli