As many as 2.5 million very preterm infants globally are at risk of developing BPD from lung damage caused by mechanical ventilation and oxygen support. BPD can cause lifelong complications such as asthma and pneumonia as well as growth and developmental problems.

The pivotal trial will begin in Italy and Spain and expand to additional countries in 2025. The randomized, double-blind, parallel-group study will enroll 316 neonates born between 23 weeks and less than 28 weeks to assess the efficacy of zelpultide alfa (administered intratracheally) when added to standard of care in preventing or reducing the severity of BPD.

“The approval of this Phase 3 trial is based on the successful completion of our randomized blinded Phase 1b study in the US and Europe, in which no dose limiting toxicities were found and indications of efficacy were observed,” said Airway Chairman, CEO and Chief Medical Officer Marc Salzberg, M.D. “Zelpultide alfa would be the first preventive therapy to protect babies from BPD, which is a debilitating lung disease.”

Dr. Salzberg added, “We are grateful to the parents of these fragile patients participating in our ground-breaking clinical trials, and we look forward to further improving the health outcomes for babies born very prematurely, hopefully representing a significant advancement in an area needing new solutions.”

These very early preterm born babies lack a vital protein in their lungs called SP-D, which is essential to the lung’s immune defense in reducing inflammation and infection while modulating immune responses. Airway Therapeutics has developed zelpultide alfa, the only recombinant version of human SP-D developed as a replacement therapy to protect the infants’ lungs.

“We feel so honored and blessed to work on the development of zelpultide alfa for prevention of BPD. The neonatology community has big hopes in this novel scientifically well supported intervention for BPD,” stated Prof. Daniele De Luca and Prof. Maximo Vento, Principal Investigators.

Zelpultide alfa has been granted orphan drug designation in US and Europe. The global market for preventing BPD is estimated in excess of $5 billion annually.

About Airway Therapeutics

Airway Therapeutics is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing zelpultide alfa, a novel recombinant human protein hSP-D that reduces inflammation and infection in the body while modulating the immune response. Zelpultide alfa is Airway’s first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID/CAP in seriously ill mechanically ventilated patients.