#USA #Marietta #Airway Therapeutics #Zelpultid Alfa #Bronchopulmonary Dysplasia

Airway Therapeutics Secures EMA Approval

Airway Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing innovative biological therapies for respiratory, inflammatory, and infectious diseases, has recently announced a significant milestone in its journey towards improving neonatal care. The European Medicines Agency (EMA) Pediatric Committee (PDCO) has granted approval for the pediatric investigation plan (PIP) involving Zelpultid alfa. This groundbreaking therapy is positioned to prevent bronchopulmonary dysplasia (BPD) in extremely preterm infants born as early as 22 to 27 weeks of gestation.

Zelpultid alfa stands out as a recombinant human surfactant protein D (rhSP-D) that modulates immune responses to reduce inflammation, enhance the clearance of pathogens, and maintain surfactant homeostasis to support lung function. This innovative approach is critical for treating a vulnerable patient group that currently lacks approved preventative therapies for BPD.

Dr. Marc Salzberg, Chairman and Chief Executive Medical Officer at Airway Therapeutics, expressed his enthusiasm regarding this milestone. “We are pleased to have reached an agreement with the PDCO on the pediatric investigation plan and study design for Zelpultid alfa. This therapy has the potential to prevent BPD in very preterm infants—a group at high risk for long-term respiratory complications—and could address a significant unmet medical need.”

The Study Ahead

The approved PIP outlines plans for a phase 2b/3 clinical trial focusing on two different dosages of Zelpultid alfa, administered over a period of up to seven days. This trial will be comparative, pitting the proposed treatments against a placebo. Upon the completion of treatment for 150 patients, with 50 assigned to each study arm, a single dose will be selected for continuation into the pivotal phase 3 study, which aims to enroll an additional 216 participants.

Dr. Daniele De Luca, the principal investigator and a pediatrics professor at Université Paris Saclay, highlighted the significance of this research. “Bronchopulmonary dysplasia remains one of the most challenging complications on the neonatal intensive care unit, leading to long-term airway and neurological issues. Zelpultid alfa represents a novel and scientifically promising approach based on our understanding of immunomodulation and tissue injury. This study will allow us to thoroughly assess its potential to transform clinical practice by addressing the causes of lung injury in extremely preterm infants.”

As part of its strategic roadmap, Airway Therapeutics plans to submit the approved protocol to health authorities in Italy, Spain, and Israel, with anticipated clinical study initiations in these countries by late third or early fourth quarter of 2025. Further submissions are also set to follow in France, Germany, Belgium, and Poland, along with regulatory applications in Argentina, Australia, and the United States.

What is Zelpultid Alfa?

Zelpultid alfa is engineered to replicate the complete quaternary structure and biological functions of native surfactant protein D, distinguished by optimized glycosylation thanks to advanced cell line technology. Its therapeutic effects hinge on three key mechanisms: modulation of immune reactions to curb excessive inflammation, boosting pathogen recognition and clearance, and sustaining surfactant homeostasis to bolster lung function.

The primary indication for Zelpultid alfa currently under a registration-focused clinical trial is the prevention of BPD, following an initial phase 1 study that demonstrated a favorable safety and tolerability profile.

About Airway Therapeutics

Airway Therapeutics is at the forefront of biopharmaceutical innovation, developing a new class of biological therapies aimed at redefining prevention and treatment strategies for respiratory, inflammatory, and infectious diseases. With Zelpultid alfa leading the charge in late-stage clinical development targeting the prevention of BPD in extremely preterm infants, the company is dedicated to making strides in enhancing outcomes for vulnerable patient populations. For more information, visit Airway Therapeutics.