Cincinnati, Ohio, U.S., September 30, 2026
Airway Therapeutics, Inc. has been awarded a $1.9 million grant from the National Institutes of Health (NIH) to advance clinical development of zelpultide alfa, the company’s investigational recombinant human SP-B protein therapy being developed to prevent bronchopulmonary dysplasia (BPD) in extremely premature infants. The NIH-supported program will help advance preparations for a pivotal Phase 2b/3 clinical study, representing an important development milestone for a therapy targeting one of the major chronic respiratory complications associated with extreme prematurity. The grant is expected to support clinical and regulatory activities as Airway Therapeutics progresses toward a larger late-stage evaluation of zelpultide alfa.
Zelpultide Alfa Targets Severe Lung Disease
Bronchopulmonary dysplasia is a chronic lung disease that primarily affects premature infants who require respiratory support after birth. The condition can result from the combination of immature lungs, inflammation, oxygen exposure and mechanical ventilation. Infants who develop BPD may require prolonged respiratory support and can experience continuing respiratory problems after leaving the neonatal intensive care unit. Because extremely premature infants have limited lung development at birth, strategies designed to protect or support developing lung function remain an important area of neonatal medicine research. Zelpultide alfa is being developed as a replacement therapy for surfactant protein B (SP-B). SP-B is an essential component of pulmonary surfactant, the substance that helps maintain the stability and function of the lung’s air sacs. Insufficient or impaired pulmonary surfactant function can contribute to respiratory distress and impaired lung function in premature infants. Airway Therapeutics is developing zelpultide alfa with the objective of supporting normal pulmonary surfactant activity and protecting developing lungs during a critical period of neonatal care. The investigational therapy is designed to address an underlying biological component of immature lung function rather than simply providing mechanical respiratory support. Its development therefore represents a potential therapeutic strategy aimed at reducing the long-term consequences associated with severe respiratory disease in extremely premature infants.
NIH Funding Supports Phase 2b/3 Development
The $1.9 million NIH grant will support activities required to advance zelpultide alfa toward a planned Phase 2b/3 study. Late-stage clinical development requires extensive preparation, including regulatory interactions, clinical trial planning, manufacturing activities and other development work needed before large-scale patient evaluation can begin. The planned Phase 2b/3 program is intended to generate additional evidence regarding the safety and efficacy of zelpultide alfa in extremely premature infants at risk of developing BPD. Earlier clinical development has provided the foundation for continued investigation, while the NIH funding is expected to help Airway Therapeutics move the program toward a pivotal evaluation. For a neonatal therapy, clinical development can involve substantial challenges because the intended patient population consists of extremely premature infants who may have complex medical conditions and require intensive respiratory care. Trial design must therefore carefully consider clinical outcomes, safety monitoring and the unique characteristics of this vulnerable population.
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Airway Therapeutics Advances BPD Prevention Program
The NIH award strengthens Airway Therapeutics’ efforts to develop zelpultide alfa as a potential preventive treatment for bronchopulmonary dysplasia. The company has focused its development program on therapies designed to improve respiratory outcomes in premature infants and address significant unmet needs in neonatal medicine. BPD remains an important complication of extreme prematurity, and currently available approaches primarily focus on supportive neonatal care and management of established respiratory disease. A therapy capable of reducing the development or severity of BPD could potentially address an important gap in neonatal care, although the clinical benefit of zelpultide alfa remains to be established through ongoing and future clinical studies.
The NIH grant also highlights the role of public-sector research funding in advancing innovative drug development programs for diseases affecting relatively small and medically vulnerable populations. Continued clinical evaluation will be required to determine whether zelpultide alfa can demonstrate sufficient safety and efficacy to support regulatory approval. For cGxP.wire, the announcement represents a significant pharmaceutical clinical-development and NIH-funded research milestone, particularly because it involves a late-stage investigational therapy targeting bronchopulmonary dysplasia in extremely premature infants.
Source: Airway Therapeutics press release
