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

Airway Therapeutics Achieves Milestone with EMA Approval

Airway Therapeutics, Inc., a cutting-edge biopharmaceutical entity focused on the development of innovative biologic treatments, has made significant progress by securing approval from the European Medicines Agency (EMA) Pediatric Committee for its Pediatric Investigation Plan (PIP). This approval is related to the company's investigational product, zelpultide alfa, which is aimed at preventing bronchopulmonary dysplasia (BPD) in very preterm infants born between 22 and 27 weeks of gestation.

Zelpultide alfa is a groundbreaking therapy designed as a recombinant human surfactant protein D (rhSP-D). Its primary function is to modulate immune responses, thereby reducing inflammation, enhancing pathogen clearance, and supporting surfactant balance, all crucial for optimal lung function in this vulnerable population.

Dr. Marc Salzberg, the CEO and Medical Officer of Airway Therapeutics, expressed enthusiasm over reaching an agreement with the Pediatric Committee regarding the PIP. He noted, “We are pleased to have reached an agreement with the PDCO on the Pediatric Investigation Plan and pivotal study design for zelpultide alfa, a ground-breaking therapy being developed to prevent BPD in very preterm infants, a highly vulnerable population with no approved preventative treatments.”

The approved PIP outlines the study design and execution plan for a pivotal Phase 2b/3 clinical trial. This trial will focus on evaluating different dosages of zelpultide alfa over a period of seven days, comparing its efficacy to a placebo. The initial phase aims to treat 150 patients, with approximately 50 individuals in each dosing arm. The data gathered will assist in determining the optimal dosage to proceed to Phase 3, which is projected to enroll about 216 additional participants.

In order to contribute to enhanced outcome measures, the study will also assess a three-day consecutive BPD evaluation endpoint.

Dr. Daniele De Luca, the principal investigator of the trial, emphasized the ongoing challenges of BPD, which remains a major complication in neonatal intensive care settings, with significant long-term impacts on both respiratory and neurodevelopmental outcomes. He referred to zelpultide alfa as a scientifically promising approach based on a thorough understanding of immune modulation and the mechanisms of tissue injury.

Airway Therapeutics is aiming to promptly submit the EMA-approved protocol to health authorities in Italy (AIFA), Spain (AEMPS), and Israel (MoH), with a goal to kick-start the clinical trial in these nations by late Q3 or early Q4 of 2025. Additional submissions are planned for France, Germany, Belgium, and Poland, with further regulatory filings anticipated in Argentina, Australia, and the United States.

A Closer Look at Zelpultide Alfa

Zelpultide alfa is no ordinary therapy; it’s precisely designed to mimic the structure and function of the native human surfactant protein D. The advanced cell line technology used in its creation ensures optimized glycosylation, enhancing its therapeutic activity through three key mechanisms:
1. Immune Modulation: Aims to reduce inflammation and prevent excessive immune responses.
2. Enhanced Pathogen Clearance: Improves the body's ability to recognize and manage pathogens effectively.
3. Surfactant Homeostasis: Maintains the balance of surfactant, essential for lung function.

Currently, zelpultide alfa is advancing through a pivotal Phase 2b/3 clinical trial concerning its lead indication of BPD prevention, following a successful Phase 1 trial that confirmed its safety and tolerability. Airway Therapeutics envisions a broadened application of zelpultide alfa, targeting a diverse age range and various disease conditions, thus striving to improve health outcomes for many vulnerable patient populations.

About Airway Therapeutics

Founded with the vision of reshaping the landscape of respiratory and inflammatory diseases, Airway Therapeutics is on a mission to develop a new class of biologic therapies. Its commitment to addressing the unmet medical needs of patients, particularly in high-risk categories such as very preterm infants, underscores its dedication to innovate and implement effective treatments.

For more detailed information, visit Airway Therapeutics.