#USA #Marietta #Airway Therapeutics #Bronchopulmonary Dysplasia #Zelpultide Alpha

Airway Therapeutics Receives Approval for Zelpultide Alpha Study

Airway Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on innovative therapies for respiratory conditions, has announced a significant advancement in its research regarding zelpultide alpha, a potential treatment for bronchopulmonary dysplasia (BPD) in very premature infants. The European Medicines Agency's Pediatric Committee (PDCO) has given the green light for the Pediatric Investigation Plan (PIP), which outlines the parameters for a clinical study targeting BPD prevention.

The upcoming multi-national dose-selection Phase 2b and Phase 3 trials of zelpultide alpha are set to commence in the latter half of 2025. This study represents a critical step forward, as it aims to address a pressing health concern—BPD—commonly affecting neonates born between 22 and 27 weeks of gestation, a demographic that currently lacks approved preventive treatments.

Zelpultide Alpha: A Promising New Therapy

Zelpultide alpha is a recombinant human surfactant protein D (rhSP-D) designed to modulate immune responses, reduce inflammation, enhance pathogen clearance, and support surfactant homeostasis, which in turn could significantly improve lung function in affected infants. As Dr. Marc Salzberg, the President and CEO of Airway Therapeutics, stated during the announcement, this therapy is not just another treatment; it represents a breakthrough innovation addressing a vital unmet medical need for extremely vulnerable newborns.

The approved research plan includes a Phase 2b trial that will compare two different doses of zelpultide alpha, administered over a period of up to seven days, against a placebo. After the initial treatment involving 150 participants, a single effective dose will be selected for subsequent evaluation in the Phase 3 study, which will enroll an additional 216 patients. One of the objectives of this extensive study is to refine efficacy metrics related to BPD, potentially transforming therapeutic pathways and patient outcomes for this critical condition.

Scientific Insight on BPD

Despite advancements in neonatal care, BPD remains one of the most complex complications in intensive care units, often resulting in enduring repercussions on respiratory and neurological development for affected children. Dr. Daniele De Luca, the principal investigator and a professor of Pediatrics at the University of Paris Saclay, emphasizes the innovative nature of zelpultide alpha. This drug is based on established scientific principles regarding immune modulation and tissue injury, thus offering a plausible means to combat the underlying causes of lung injury in extremely premature infants—a population with very few existing treatment options.

Airway Therapeutics is advancing preparations to submit the approved PIP protocol to health authorities in Italy (AIFA), Spain (AEMPS), and Israel (MoH) with the aim of initiating clinical trials in those countries in late 2025. Further submissions are planned in France, Germany, Belgium, and Poland, along with anticipated regulatory applications in Argentina, Australia, and the United States.

The Future of Zelpultide Alpha

The development of zelpultide alpha not only aims to provide a targeted approach to prevent BPD but also opens avenues for broader applications. The therapy is being designed with versatility to tackle respiratory, inflammatory, and infectious conditions across various age groups—all aiming for improved medical outcomes in vulnerable patient populations.

To conclude, this announcement marks a critical milestone in the ongoing journey towards safe and effective therapies for BPD, directly contributing to better health outcomes for some of the most fragile individuals—premature infants—while addressing a dire need in neonatal care.

For more information about Airway Therapeutics, please visit Airway Therapeutics' Website.