Airway Therapeutics Wins 2024 ATS Whitsett Award for Abstract of Positive Phase 1b Results of Zelpultide Alfa in Preterm Neonates at Risk of Bronchopulmonary Dysplasia
24 June 2024 - 10:30AM
Business Wire
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
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.
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Media contact: Meghan Riley riley@airwaytherapeutics.com