ONY Biotech is excited to announce that the first patient has been enrolled in the Aero-05 clinical study, marking a significant milestone in the evaluation of non-invasive surfactant delivery for neonatal respiratory distress syndrome (RDS). This study is designed to assess the efficacy and safety of InfasurfAero™, our novel delivery system for aerosolized Infasurf® (calfactant).
About the Aero-05 Study
The Aero-05 study is a Phase 3, double-blind, randomized, sham-controlled clinical trial designed to assess whether a single dose of aerosolized Infasurf can prevent continuous positive airway pressure (CPAP) failure. The trial plans to enroll approximately 220 preterm infants, born between 29 weeks 0 days and 35 weeks 6 days of gestation, with birth weights ranging from 1,000 to 3,500 grams, that have RDS and are stable on non-invasive nasal respiratory support.
Primary objectives:
- To assess the effectiveness of a single dose of Infasurf administered through InfasurfAero™ in preventing CPAP failure.
- To evaluate the safety of Infasurf when delivered via InfasurfAero™.
Advancing Neonatal Care
The study will take place across 10+ clinical sites. The enrollment of the first patient signifies an important step toward furthering our understanding of the potential benefits of non-invasive surfactant administration. Research from earlier studies has shown that aerosolized surfactant can nearly halve the need for intubation in newborns experiencing early, mild to moderate respiratory distress. By reducing the need for intubation and invasive surfactant administration, this approach could help reduce adverse events and complications, ultimately improving outcomes for preterm infants.
ONY Biotech remains committed to advancing neonatal respiratory care through innovation and research. Stay tuned for more information on how InfasurfAero™ could shape the future of neonatal respiratory care.
For more details about our research and ongoing clinical trials, visit ONY Biotech’s Pipeline.