The trial will assess the efficacy of the drug, which has been granted orphan drug designation, when added to the standard of care in preventing or reducing the severity of bronchopulmonary dysplasia.
RT’s Three Key Takeaways:
- Zelpultide Alfa Targets BPD Prevention: The recombinant protein therapy, administered intratracheally, aims to prevent or reduce the severity of bronchopulmonary dysplasia (BPD) in preterm infants born between 23 and 28 weeks gestation.
- Multinational Phase 3 Trial to Begin in December: The trial will launch in Italy and Spain, enrolling 316 preterm infants, with plans to expand to additional countries in 2025.
- Previous Trial Showed Promising Safety and Efficacy: A completed phase 1b study found no dose-limiting toxicities and suggested potential efficacy, supporting the launch of the phase 3 trial.
Biopharmaceutical company Airway Therapeutics Inc announced it will launch a multinational phase 3 clinical trial in December of zelpultide alfa (rhSP-D) for the prevention of bronchopulmonary dysplasia (BPD) and minimization of resulting lung damage in preterm infants.
As many as 2.5 million very preterm infants globally are at risk of developing BPD from lung damage caused by mechanical ventilation and oxygen support. BPD can cause lifelong complications such as asthma and pneumonia as well as growth and developmental problems.
The pivotal trial will begin in Italy and Spain and expand to additional countries in 2025. The randomized, double-blind, parallel-group study will enroll 316 neonates born between 23 weeks and less than 28 weeks to assess the efficacy of zelpultide alfa (administered intratracheally) when added to standard of care in preventing or reducing the severity of BPD.
“The approval of this phase 3 trial is based on the successful completion of our randomized blinded phase 1b study in the US and Europe, in which no dose-limiting toxicities were found, and indications of efficacy were observed,” says Airway chairman, CEO, and chief medical officer Marc Salzberg, MD, in a release. “Zelpultide alfa would be the first preventive therapy to protect babies from BPD, which is a debilitating lung disease.”
Salzberg adds, “We are grateful to the parents of these fragile patients participating in our groundbreaking clinical trials, and we look forward to further improving the health outcomes for babies born very prematurely, hopefully representing a significant advancement in an area needing new solutions.”
These very early preterm-born babies lack a vital protein in their lungs called SP-D, which is essential to the lung’s immune defense in reducing inflammation and infection while modulating immune responses. Airway Therapeutics has developed zelpultide alfa, a recombinant version of human SP-D developed as a replacement therapy to protect the infants’ lungs.
Zelpultide alfa has been granted orphan drug designation in the United States and Europe.
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