- Multinational Phase 2b dose selection and Phase 3 expansion study for zelpultide alfa set to begin in late Q3/Q4 2025
MARIETTA, Ga., Aug. 12, 2025 /PRNewswire/ -- Airway Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel biologic therapies for respiratory, inflammatory, and infectious diseases, today announced that the European Medicines Agency (EMA) Pediatric Committee (PDCO) has approved its Pediatric Investigation Plan (PIP) for its investigational biologic, zelpultide alfa, in its initial indication for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants born between 22 and 27 weeks gestational age.
Zelpultide alfa is a first-in-class recombinant human surfactant protein D (rhSP-D) designed to modulate immune responses to reduce inflammation, enhance pathogen clearance, and support surfactant homeostasis for improved lung function.
"We are pleased to have reached agreement with the PDCO on the Pediatric Investigation Plan and pivotal study design for zelpultide alfa, a ground-breaking therapy being developed to prevent BPD in very preterm infants, a highly vulnerable population with no approved preventative treatments," said Dr. Marc Salzberg, Chairman, Chief Executive & Medical Officer of Airway Therapeutics. "This marks a significant milestone in advancing a potential first-in-class preventive therapy to improve outcomes for these fragile infants and address a critical unmet medical need."
The approved PIP includes the design and execution plan for a pivotal Phase 2b/3 clinical trial. The Phase 2b trial will evaluate two different dose levels of zelpultide alfa administered for up to seven days, compared to placebo. Following completion of treatment in 150 patients (50 per arm), one dose will be selected for continuation into Phase 3, during which approximately 216 additional patients will be enrolled. As part of the study, Airway Therapeutics will assess a three-day consecutive BPD evaluation endpoint, which may contribute to the development of improved outcome measures during the studies.
"Bronchopulmonary dysplasia remains one of the most challenging complications in neonatal intensive care, with long-term consequences for respiratory and neurodevelopmental outcomes," said Dr. Daniele De Luca, Principal Investigator of the trial and Professor of Pediatrics (Neonatology) at Paris Saclay University. "Zelpultide alfa represents a novel and scientifically promising approach, grounded in our understanding of immune modulation and tissue injury. This study will allow us to rigorously evaluate its potential to change clinical practice by addressing the root drivers of lung injury in very preterm infants."
Airway Therapeutics plans to submit the PDCO-approved protocol immediately to health authorities in Italy (AIFA), Spain (AEMPS), and Israel (MoH), with the objective of initiating the clinical trial in these countries in late Q3 or Q4 2025. Additional submissions will follow in France, Germany, Belgium, and Poland, along with planned regulatory filings in Argentina, Australia, and the United States.
About Zelpultide Alfa
Zelpultide alfa is a recombinant human surfactant protein D (rhSP-D) precisely engineered to replicate the native protein's full quaternary structure and biological function, incorporating optimized glycosylation through advanced cell line technology.
Its therapeutic activity is driven by three key mechanisms: modulation of immune responses to mitigate excessive inflammation, enhancement of pathogen recognition and clearance, and maintenance of surfactant homeostasis to support pulmonary function. As a versatile biologic platform, zelpultide alfa is being developed for patients across all age groups-from preventing bronchopulmonary dysplasia (BPD) in very preterm infants to treating acute and chronic respiratory, inflammatory and infectious conditions in adults.
Zelpultide alfa's lead indication, BPD prevention, is currently progressing through a pivotal Phase 2b/3 clinical trial, following Phase 1 study that demonstrated a favorable safety and tolerability profile.
About Airway Therapeutics
Airway Therapeutics is a clinical-stage biopharmaceutical company developing a new class of biologic therapies to redefine the prevention and treatment of respiratory, inflammatory, and infectious diseases. Its lead candidate, zelpultide alfa, is currently in late-stage clinical development for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants, a condition with no approved preventive therapies. As a platform biologic, zelpultide alfa is also being advanced for broader application across age groups and disease settings, with the goal of improving outcomes for vulnerable patient populations.
For more information, please visit https://www.airwaytherapeutics.com
Company Contact:
Libba Muzi
Airway Therapeutics
muzi@airwaytherapeutics.com
513-770-9630
Media Contact:
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Russo Partners, LLC
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212-845-4251
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