Airway Therapeutics Receives Approval for Zelpultide Alfa Study in Preterm Infants
Wednesday, August 13, 2025
Airway Therapeutics has received approval from the European Medicines Agency’s Paediatric Committee (PDCO) for its Paediatric Investigation Plan (PIP) for zelpultide alfa.
Zelpultide alfa is being developed for a range of respiratory, inflammatory, and infectious diseases, from neonatal BPD prevention to adult acute and chronic conditions. The current programme follows a Phase 1 study that showed a favourable safety and tolerability profile.
Zelpultide alfa is a recombinant human surfactant protein D (rhSP-D) designed to reduce inflammation, improve pathogen clearance, and maintain surfactant balance to support lung function. It is the first therapy of its kind for this high-risk group, for whom no approved preventive treatment currently exists.
The investigational biologic is being developed to prevent bronchopulmonary dysplasia (BPD) in very preterm infants born between 22 and 27 weeks of gestation.
The approved PIP outlines a pivotal Phase 2b/3 trial. The Phase 2b stage will compare two dose levels administered for up to seven days against a placebo. Following treatment in 150 patients, one dose will be selected for Phase 3, which will enrol about 216 additional participants. The trial will also assess a three-day BPD endpoint to explore improved outcome measures.
The company plans to submit the protocol for regulatory review in Italy, Spain, and Israel, aiming to start the trial in these countries by late 2025. Further submissions are expected in France, Germany, Belgium, Poland, and in markets including Argentina, Australia, and the United States.
Source: prnewswire.com
