#USA #Marietta #Airway Therapeutics #Zelpultide Alfa #BPD prevention

Airway Therapeutics Achieves Landmark Approval from EMA for Zelpultide Alfa

Airway Therapeutics, a company at the forefront of biopharmaceutical innovation, has received significant recognition from the European Medicines Agency (EMA). Their investigational treatment, zelpultide alfa, has been granted a Pediatric Investigation Plan (PIP) approval. This groundbreaking study aims to tackle the severe condition bronchopulmonary dysplasia (BPD) in extraordinarily preterm infants born between 22 and 27 weeks of gestation.

Introduction to Zelpultide Alfa
Zelpultide alfa showcases a first-in-class recombinant human surfactant protein D (rhSP-D). It has been designed specifically to modulate immune responses, consequently reducing inflammation, aiding in the clearance of pathogens, and maintaining surfactant homeostasis. These mechanisms collectively contribute to enhancing lung function.

Dr. Marc Salzberg, Chairman and Chief Medical Officer at Airway Therapeutics, expressed his excitement about the agreement reached with the Pediatric Committee (PDCO) on the PIP, stating it represents a crucial step towards improving outcomes for highly vulnerable infants suffering from BPD. He emphasized the lack of approved preventative treatments for this condition, making zelpultide alfa a significant advancement in pediatric health.

BPD is a serious complication often faced in neonatal intensive care units, leading to lasting effects on respiratory and neurodevelopmental outcomes. Dr. Daniele De Luca, the trial’s Principal Investigator and a Professor of Pediatrics at Paris Saclay University, also noted that the therapy offers a novel and scientifically grounded approach to combat the intrinsic factors leading to lung injuries in preterm infants.

Study Details and Future Plans
The approved PIP sets forth a multi-phase clinical trial comprising Phase 2b and Phase 3 trials. The initial Phase 2b will focus on assessing two dosing levels of zelpultide alfa administered over seven days, juxtaposed against a placebo group. Following the treatment of 150 patients, one dosing regimen will advance into the Phase 3 trial. Here, an additional 216 participants will join the study, where researchers will track a three-day consecutive evaluation targeting BPD.

Airway Therapeutics anticipates submitting the PDCO-approved protocol to health authorities across multiple countries, including Italy, Spain, and Israel, with hopes to commence the clinical trial by late 2025. Future submissions will extend to France, Germany, Belgium, Poland, and even further afield into Argentina, Australia, and the United States.

About Zelpultide Alfa's Mechanism
Zelpultide alfa’s therapeutic profile rests on three operational mechanisms: modulation of immune responses to thwart excessive inflammation, enhancement of pathogen detection and elimination, and the preservation of surfactant equilibrium vital for lung function. Such features render zelpultide alfa a versatile biologic, showing potential across wider demographics — from preventing BPD in very preterm infants to addressing various respiratory, inflammatory, and infectious conditions in adults.

As Airway Therapeutics continues to advance zelpultide alfa — which is already in late-stage clinical development — the company strengthens its commitment to redefining treatment paradigms for challenging conditions like BPD, where treatment options have been severely limited. Their innovative approach to therapeutic design is poised to improve patient outcomes significantly, especially in vulnerable populations who have traditionally faced a lack of treatment options.

Conclusion
This EMA approval heralds a new era in the management of BPD, providing hope for many families impacted by this severe condition in premature infants. As Airway Therapeutics carves its path forward, the commitment to thorough scientific evaluation will remain at the forefront of their endeavors to bring zelpultide alfa to market, ultimately aiming to fulfill an urgent medical need in neonatal care.

For more insights and updates, visit Airway Therapeutics.