Airway Therapeutics Gains EMA Approval for Study Plan of Zelpultide Alfa in Preventing Bronchopulmonary Dysplasia in Very Preterm Infants
Wednesday, August 13, 2025
Airway Therapeutics, Inc., a clinical-stage biopharmaceutical company developing biologic therapies for respiratory, inflammatory, and infectious diseases, has received approval from the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) for its Paediatric Investigation Plan (PIP) for zelpultide alfa. The initial focus is on preventing bronchopulmonary dysplasia (BPD) in very preterm infants born between 22 and 27 weeks of gestation.
Zelpultide alfa is a first-in-class recombinant human surfactant protein D (rhSP-D) designed to modulate immune responses, reduce inflammation, enhance pathogen clearance, and maintain surfactant balance to improve lung function.
The approved plan includes a pivotal Phase 2b/3 clinical trial. The Phase 2b stage will test two dosage levels of zelpultide alfa, administered for up to seven days, against placebo. Treatment will be evaluated in 150 patients, with one dose selected for the Phase 3 stage, which will enrol around 216 additional patients. The study will also assess a three-day consecutive BPD evaluation endpoint, aiming to improve outcome measures for the trials.
BPD is one of the most common and challenging complications in neonatal intensive care, often leading to long-term respiratory and neurodevelopmental issues. There are currently no approved preventive treatments for this condition in very preterm infants.
Airway Therapeutics plans to submit the PDCO-approved protocol to regulatory bodies in Italy, Spain, and Israel, with the aim of starting the trial in these countries in late Q3 or Q4 2025. Further submissions are expected in France, Germany, Belgium, and Poland, alongside planned filings in Argentina, Australia, and the United States.
Source: prnewswire.com
