Airway Therapeutics Secures $1.9 Million NIH Grant for BPD Study

Airway Therapeutics, Inc., a biopharmaceutical company currently in late-stage clinical development, has announced that it has been awarded a grant of $1.9 million from the National Institutes of Health (NIH). This grant will support the company's Phase 2b/3 study focused on Zelpultide alfa, targeting the prevention of bronchopulmonary dysplasia (BPD) in extremely preterm infants.

The funding comes from the NIH's National Heart, Lung, and Blood Institute (NHLBI) as part of the Small Business Innovation Research (SBIR) program. This non-dilutive financial boost is intended to enhance Airway Therapeutics' clinical development efforts for addressing BPD—an affliction for which there are currently no approved preventive therapies.

Dr. Marc Salzberg, the company’s Managing Director, Chairman, and CEO, remarked on the significance of this grant: "This NIH funding is a vital acknowledgment of the scientific rationale behind our program and reflects the urgent need for new preventive strategies in addressing BPD. It strengthens our ability to implement our late-stage development strategy and advance a differentiated biological product in a field with significant unmet medical needs. We remain focused on progressing the clinical development of Zelpultide alfa and evaluating its potential to improve treatment outcomes for at-risk premature infants."

BPD is a serious chronic lung disease typically found in preterm infants, characterized by inflammation and damage to the developing lungs. Preterm infants are particularly vulnerable due to underdeveloped lung defense mechanisms, including those mediated by surfactant protein D (SP-D). SP-D is crucial for regulating lung inflammation, supporting the innate immune response, and maintaining surfactant homeostasis. The recombinant human SP-D, Zelpultide alfa, aims to restore these protective functions in very premature infants whose immature lungs are at heightened risk for inflammation and damage that can lead to BPD.

The ongoing Phase 2b program in the United States builds upon positive safety and tolerability results from a completed Phase 1b trial of Zelpultide alfa, alongside a promising initiation of clinical studies in Europe, Argentina, and Israel. This advanced-stage trial aims to further evaluate the efficacy and safety of Zelpultide alfa in comparison to standard therapy in high-risk preterm infants, with the objective of assessing its potential to reduce both the incidence and severity of BPD.

About Zelpultide Alfa

Zelpultide alfa, a recombinant human surfactant protein D (rhSP-D), is precisely engineered to mirror the complete quaternary structure and biological function of the native protein through advanced cell line technology that incorporates optimized glycosylation. Its therapeutic efficacy is based on three key mechanisms that modulate immune responses to alleviate excessive inflammation, enhance pathogen recognition and clearance, and maintain surfactant homeostasis to support lung function. As a versatile biological platform, Zelpultide alfa is being developed for patients of all ages, ranging from preventing BPD in extremely preterm infants to treating acute and chronic respiratory, inflammatory, and infectious disorders in adults.

Currently, Zelpultide alfa’s primary indication, the prevention of BPD, is undergoing a clinical study in the Phase 2b/3 stage following positive safety and tolerability findings from the Phase 1b study.

About Airway Therapeutics

Airway Therapeutics is a biopharmaceutical company in late-stage clinical development, dedicated to developing a new class of biological therapies aimed at redefining the prevention and treatment of respiratory, inflammatory, and infectious diseases. Its lead candidate, Zelpultide alfa, is currently in late-stage clinical development for the prevention of bronchopulmonary dysplasia (BPD) in extremely preterm infants, a condition for which no preventive therapies have yet been approved. As a platform biologic, Zelpultide alfa is also being further developed for broader applications across various age groups and disease indications, with the aim of improving treatment outcomes for particularly vulnerable patient populations.