Airway Therapeutics, Inc. has announced the launch of a multinational Phase 3 clinical trial for zelpultide alfa (rhSP-D). This study aims to prevent bronchopulmonary dysplasia (BPD) and mitigate lung injury in premature infants. The biopharmaceutical company focuses on developing innovative biologics to address respiratory and inflammatory diseases.
Up to 2.5 million extremely premature infants worldwide face the risk of developing bronchopulmonary dysplasia (BPD) due to lung damage from mechanical ventilation and oxygen support. BPD can lead to lifelong issues, including asthma, pneumonia, and developmental challenges.
Airway Therapeutics will launch a pivotal Phase 3 clinical trial starting in Italy and Spain, expanding to additional countries in 2025. This randomized, double-blind, parallel-group study will involve 316 newborns born between 23 and 28 weeks of gestation, evaluating the efficacy of zelpultide alfa (administered intratracheally) when added to standard care in preventing or lessening the severity of BPD.
Marc Salzberg, Airway’s Chairman, CEO, and Chief Medical Officer, stated, “The approval of this Phase 3 study follows the successful completion of our randomized, blinded Phase 1b study in the U.S. and Europe, which found no dose-limiting toxicities and showed promising efficacy.” He emphasized that zelpultide alfa could be the first preventive therapy for BPD, a serious lung condition.
Dr. Salzberg expressed gratitude to the parents of these vulnerable infants for participating in the clinical trials and underscored the goal of improving health outcomes for preterm babies.
Very premature infants lack a critical lung protein, SP-D, which is vital for immune defense, reducing inflammation, and managing infections. Zelpultide alfa is the only recombinant form of human SP-D, designed as a replacement therapy to protect these infants’ lungs.
Professors Daniele De Luca and Maximo Vento, principal investigators, noted, “We are honored to develop zelpultide alfa as a scientifically sound intervention for BPD, which the neonatology community has high expectations for.”
Zelpultide alfa has received orphan drug designation in the U.S. and Europe, and the global market for BPD prevention is estimated to exceed $5 billion annually.
About Airway Therapeutics
Airway Therapeutics is a biopharmaceutical company focused on developing innovative biologics to address injury and inflammation in respiratory and inflammatory diseases, starting with vulnerable populations. Zelpultide alfa is their first candidate aimed at preventing BPD in extremely preterm infants and treating COVID/CAP in critically ill patients on ventilation.
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