US-based biotechnology company Airway Therapeutics is to launch a multinational Phase III clinical trial of zelpultide alfa, a drug designed to prevent bronchopulmonary dysplasia (BPD) in preterm infants.
The randomised, double-blind, parallel-group trial will enrol 316 babies born between 23 and 28 weeks’ gestation.
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It will evaluate the efficacy of zelpultide alfa, when administered intratracheally in conjunction with standard of care, to prevent or reduce the severity of BPD.
The trial is due to begin in December this year in Italy and Spain, with plans to expand to additional countries next year.
Preterm neonates often lack sufficient levels of a critical lung protein known as SP-D, which is crucial for immune defence, reducing inflammation and modulating immune responses.
Zelpultide alfa is a recombinant version of human SP-D and could potentially serve as a replacement therapy to safeguard the lungs of these vulnerable infants.
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By GlobalDataThe asset has received orphan drug designation in both the US and Europe.
Zelpultide alfa is Airway Therapeutics’ first candidate in development for the prevention of BPD in very preterm infants and to treat Covid-19 and community-acquired pneumonia in critically ill, mechanically ventilated patients.
Airway Therapeutics chairman, CEO and chief medical officer Marc Salzberg said: “The approval of this Phase III trial is based on the successful completion of our randomised blinded Phase Ib study in the US and Europe, in which no dose-limiting toxicities were found and indications of efficacy were observed.
“We are grateful to the parents of these fragile patients participating in our ground-breaking clinical trials, and we look forward to further improving the health outcomes for babies born very prematurely, hopefully representing a significant advancement in an area needing new solutions.”
Based in Marietta, Georgia, Airway Therapeutics develops biologics to treat injury and inflammation in patients with respiratory and inflammatory diseases.
