Airway Therapeutics to Begin Global Phase 3 Trial of Zelpultide Alfa for Preterm Infants at Risk of BPD

ATLANTA, GA, USA I October 15, 2024 I Airway Therapeutics, Inc., a biopharmaceutical company, announced its plan to initiate a multinational Phase 3 clinical trial in December 2024 for zelpultide alfa (rhSP-D). This drug aims to prevent bronchopulmonary dysplasia (BPD) and minimize lung damage in preterm infants.

Globally, around 2.5 million very preterm infants are at risk of BPD, a condition caused by the damage from mechanical ventilation and oxygen support. This disease can lead to lifelong issues such as asthma, pneumonia, and growth and developmental delays.

The upcoming pivotal trial will start in Italy and Spain, with plans to expand to other countries in 2025. It will be a randomized, double-blind, parallel-group study involving 316 neonates born between 23 and less than 28 weeks of gestation. The trial will assess the efficacy of zelpultide alfa, administered intratracheally, alongside the standard care to prevent or reduce BPD severity.

Marc Salzberg, M.D., Chairman, CEO, and Chief Medical Officer of Airway Therapeutics, stated that the approval for this Phase 3 trial is based on the positive outcomes from their Phase 1b study in the US and Europe. The study showed no dose-limiting toxicities and signs of efficacy. If successful, zelpultide alfa could become the first therapy to prevent BPD, a severe lung disease.

Dr. Salzberg expressed gratitude towards the parents who allow their fragile infants to participate in these groundbreaking clinical trials, hoping to improve health outcomes for very premature babies. This potential therapy could mark a significant advancement in addressing unmet needs in neonatal care.

Preterm infants lack a crucial lung protein called SP-D, essential for lung immune defense, reducing inflammation and infection, and modulating immune responses. Airway Therapeutics has developed zelpultide alfa as a recombinant human SP-D to replace this protein and protect infants' lungs.

Professors Daniele De Luca and Maximo Vento, Principal Investigators, expressed their honor and excitement to work on zelpultide alfa's development for BPD prevention. The neonatology community holds high hopes for this scientifically supported intervention.

Zelpultide alfa has received orphan drug designation in both the US and Europe. The global market for BPD prevention is valued at over $5 billion annually.

Airway Therapeutics focuses on developing biologics to break the cycle of injury and inflammation in patients with respiratory and inflammatory diseases, starting with the most vulnerable populations. The company's lead candidate, zelpultide alfa, is a novel recombinant human protein hSP-D designed to reduce inflammation and infection while modulating the immune response. It is currently being developed for BPD prevention in very preterm infants and for treating COVID/CAP in critically ill, mechanically ventilated patients.