Bronchopulmonary dysplasia

A Critical Unmet Need

Bronchopulmonary dysplasia (BPD) is a serious chronic lung disease that primarily affects very preterm infants requiring prolonged respiratory support. It is defined by a continued need for supplemental oxygen and/or ventilation, with severity classified according to respiratory support requirements at 36 weeks postmenstrual age (PMA). The disease arises from a convergence of factors, including lung immaturity, reduced surfactant protein D (SP-D) expression, ventilation–associated injury, oxygen toxicity, inflammation, and secondary infections. Together, these insults impair alveolarization and vascular development, resulting in impaired gas exchange, chronic lung injury, and an increased risk of neurodevelopmental delay and other acute and long-term comorbidities.

Key Facts

  • Epidemiology: Affects ~50% of neonates <28 weeks GA (~600,000 at risk annually).
  • Unmet Need: No approved therapies to prevent BPD; current treatments manage symptoms or complications only.
  • Economic Burden: Neonatal intensive care costs $8,000 or more per day, mean hospitalization costs of ~$700,000 in the first year; prolonged stays drive billions in annual costs.​
  • Clinical Opportunity: Zelpultide alfa has Orphan Drug Designation in the U.S. and EU and is currently in a Phase 2b/3 trial.
  • Investor Opportunity: Peak global sales estimated at $6B.

Phase 1B Trial – Early Success in BPD

Airway’s Phase 1B trial evaluated the safety, tolerability, and preliminary efficacy of zelpultide alfa in extremely preterm infants, demonstrating promising early clinical results. The study was randomized, blinded, and placebo controlled, across 20 sites in the U.S. and Spain, with dosing started within 48 hours of intubation.

Key Results

  • Cohorts: Four GA-based cohorts (23–<29 weeks), including 3 dose-escalation cohorts.
  • Safety: Well-tolerated with no dose-limiting toxicities; mortality consistent with historical norms.
  • Efficacy Signals: 30% relative risk reduction in grade 2 or grade 3 BPD or death; no grade 3 BPD in treatment group. Exploratory analysis: 55% risk reduction among infants surviving >14 days.
  • Mechanical Ventilation: 8 fewer days (31% reduction) at 36 weeks PMA.
  • Hospitalization: Average 96 hospital days in first year vs 127 days for controls.