Company plans to initiate a multinational pivotal trial of zelpultide alfa (rhSP-D) in Q4/2024 beginning in Europe. The study will enroll more than 300 neonates born at 23 weeks to 27 weeks and 6 days
ATLANTA–(BUSINESS WIRE)– Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, announced today it received the Whitsett Award for highest scoring abstracts from the Neonatal and Developing Lung Executive Committee at the American Thoracic Society (ATS) 2024 International Conference.
The abstract is titled “Randomized Blinded Phase 1b Study Demonstrates Safety and Tolerability of Zelpultide Alfa (rhSP-D) in Preterm Neonates at High Risk for the Development of Bronchopulmonary Dysplasia (BPD).” Thirty-seven infants, born at 23 weeks to 28 weeks and 6 days, were enrolled in the study in the US and Europe. No dose limiting toxicities were found while indications of efficacy were observed.
As many as 2.5 million very preterm infants globally are at risk of developing BPD from lung damage caused by mechanical ventilation and oxygen support. Babies who develop BPD can suffer lifelong complications such as asthma and pneumonia as well as growth and developmental problems.
The Whitsett Award is named for Jeffrey A. Whitsett, M.D., Director of the Section of Neonatology, Perinatal and Pulmonary Biology at Cincinnati Children’s Hospital Medical Center. Raquel Arroyo, Ph.D., PharmD, Airway’s Director of Clinical Sciences, accepted the award as lead author of the abstract.
“We are grateful to the parents of these fragile patients participating in the first clinical study with zelpultide alfa in very preterm neonates, and also thank the investigators and their study teams for their participation,” said Airway CEO and Chief Medical Officer Marc Salzberg, M.D. “Dr. Arroyo proudly received the Whitsett award on behalf of the investigators and in recognition of her invaluable contribution to the development of zelpultide alfa. Based on the successful completion of the Phase 1b study we plan to launch a pivotal multinational trial in Q4/2024 enrolling more than 300 neonates born at 23 weeks to 27 weeks and 6 days.”
The pivotal trial, which will begin in Spain and Italy, will be a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy of zelpultide alfa (administered intratracheally) in preventing BPD compared to standard of care plus air-sham (intratracheal administration of room air).
Zelpultide alfa is a recombinant version of the endogenous human SP-D, a protein essential to the lung’s immune defense in reducing inflammation and infection while modulating immune responses. The biologic is administered intratracheally during mechanical ventilation. The FDA and European Medicines Agency have granted orphan drug status to zelpultide alfa.
About Airway Therapeutics
Airway Therapeutics is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing zelpultide alfa, a novel recombinant human protein hSP-D that reduces inflammation and infection in the body while modulating the immune response. Zelpultide alfa is Airway’s first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID/CAP in seriously ill mechanically ventilated patients.
Media contact:
Meghan Riley riley@airwaytherapeutics.com
Source: Airway Therapeutics, Inc.
