Initiating bronchopulmonary dysplasia (BPD) clinical trial in very preterm infants in 2020 with orphan drug designation
Advancing preclinical research in influenza, RSV, cystic fibrosis
Bolsters executive leadership with key finance and regulatory hires
CINCINNATI, OH (January 8, 2020) – Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the injury cycle of inflammation for patients with respiratory and inflammatory diseases, announced today the closing of a $15.5 million oversubscribed Series C financing round. This funding will enable clinical development of AT-100 (rhSP-D), an investigational preventive treatment for the serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants, while also supporting preclinical research in influenza, respiratory syncytial virus (RSV) and cystic fibrosis.
“We are pleased to have the strong support of our existing investor base and the new investors for the round,” said John M. Rice, Ph.D., Airway Therapeutics’ Chairman of the Board and Managing Director, CincyTech.
AT-100 is a novel recombinant human protein rhSP-D, an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response to break the injury cycle of inflammation. Preclinical research in BPD demonstrated that Airway’s AT-100 prevented the onset of lung tissue damage, and reduced inflammation and infection triggered by mechanical ventilation and oxygen support. The U.S. Food and Drug Administration and European Medicines Agency have granted AT-100 Orphan Drug Designation.
“We are pleased to announce the latest round of funding for Airway Therapeutics, which will enable the company to initiate the first clinical trial with AT-100, our novel recombinant human protein for prevention of BPD in very preterm neonates,” said Marc Salzberg, M.D., president and CEO of Airway. “In preclinical studies, AT-100 reduced inflammation and infection, while also modulating the immune system. We expect to initiate our BPD Phase 1b/2 clinical trial in the second half of 2020, where we will begin evaluating AT-100’s potential in patients with limited preventive and treatment options.”
Very preterm neonates whose lungs are not fully developed are intubated and ventilated to allow breathing, but the mechanical ventilation and oxygenation can cause lung inflammation and infection, resulting in the arrest of lung development and ultimately BPD.
“Consequently, these premature babies suffer from short- and long-term respiratory and neurodevelopmental issues,” said Dr. Salzberg. “There are currently no approved treatments for BPD, and AT-100 has the potential to reduce the incidence and severity of BPD, reduce the amount of time of intubation and intensive care, and ultimately improve the survival and life of these vulnerable patients.”
As many as 160,000 preterm babies are at high risk to develop BPD each year in the U.S. and Europe. Babies with BPD have higher mortality and those that survive suffer from lifelong chronic consequences. Management of the disease costs an estimated $2 billion annually in the U.S. alone.
AT-100’s anti-inflammatory and anti-infective properties also make it a potential treatment for other respiratory diseases such as influenza, RSV, cystic fibrosis, asthma and COPD. Funding from the Series C financing will enable Airway to further develop its preclinical package for influenza, RSV and cystic fibrosis in preparation for additional clinical trials in 2021.
In addition to the financing, Airway announced recent hires of Mr. Alan S. Wolk as Chief Financial and Operating Officer and Mr. Uday Patel as Vice President of Regulatory Affairs and Quality. Mr. Wolk has more than 30 years of finance and general management experience with DuPont and Invista, a subsidiary of Koch Industries, while also serving as a finance instructor at the University of Georgia’s Terry College of Business. Mr. Patel has more than 25 years of experience covering all aspects of biopharmaceutical clinical development, including program management, clinical operations, regulatory affairs, analytical development and quality. He holds a bachelor’s degree in Biochemistry from Suffolk University and a Master’s degree in Biology from Harvard University.
AT-100 is a novel recombinant human protein rhSP-D, an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response to break the injury cycle of inflammation. AT-100’s anti-inflammatory and anti-infective properties also make it a potential treatment for other respiratory diseases such as influenza, RSV, cystic fibrosis, asthma, COPD and inflammatory diseases outside the lung.
About bronchopulmonary dysplasia
Bronchopulmonary dysplasia is a ventilation-induced respiratory illness affecting 160,000 very preterm infants in the U.S. and the EU each year. BPD creates long-term lung damage that can lead to prolonged NICU stays, a range of co-morbidities and even death.
About Airway Therapeutics
Airway Therapeutics, based in Cincinnati, OH, is a biopharmaceutical company developing a new class of biologics to break the injury cycle of inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing the novel recombinant human protein rhSP-D, an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response. Airway’s first candidate AT-100 is in development for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants. To learn more, visit https://www.airwaytherapeutics.com.