Airway Therapeutics, a biopharmaceutical company focused on respiratory and inflammatory diseases, has announced the initiation of a multinational Phase 3 clinical trial for zelpultide alfa (rhSP-D) in December 2024. The trial aims to evaluate the efficacy of zelpultide alfa in preventing bronchopulmonary dysplasia (BPD) and minimizing lung damage in preterm infants.
Addressing a Critical Need in Preterm Infants
BPD poses a significant risk to approximately 2.5 million preterm infants globally, resulting from lung damage caused by mechanical ventilation and oxygen support. This condition can lead to lifelong complications, including asthma, pneumonia, and developmental issues. Zelpultide alfa is designed to address the deficiency of SP-D, a vital protein in the lungs of these infants that is essential for immune defense, inflammation reduction, and immune response modulation.
Trial Design and Objectives
The Phase 3 trial is structured as a randomized, double-blind, parallel-group study, enrolling 316 neonates born between 23 and 28 weeks of gestation. The study will commence in Italy and Spain, with plans for expansion to additional countries in 2025. Participants will receive zelpultide alfa intratracheally in conjunction with standard care. The primary endpoint is to assess the effectiveness of zelpultide alfa in preventing or reducing the severity of BPD.
Scientific Rationale and Prior Findings
The decision to proceed with the Phase 3 trial is supported by the successful completion of a Phase 1b study conducted in the US and Europe. According to Airway Chairman, CEO, and Chief Medical Officer Marc Salzberg, M.D., the Phase 1b study demonstrated no dose-limiting toxicities and showed indications of efficacy. Zelpultide alfa has been granted orphan drug designation in both the US and Europe, underscoring its potential to address an unmet medical need.
Market Opportunity
The global market for preventing BPD is estimated to exceed $5 billion annually. If approved, zelpultide alfa would be the first preventive therapy to protect babies from BPD, representing a significant advancement in neonatology.
