Windtree Therapeutics has announced the enrollment of the first patient in a Phase 2b bridging study of Aerosurf aerosolized KL4 surfactant in premature infants with respiratory distress syndrome (RDS). In March 2020, Windtree announced that Lee Pharmaceuticals would provide funding for the bridging study, which will evaluate use of the company’s new aerosol delivery system (ADS) in the neonatal intensive care unit as well as a new dosing regimen.
A previous Phase 2b study of Aerosurf for this indication failed to meet its primary endpoint, which the company attributed to problems with the prototype delivery device that resulted in interruptions of Aerosurf delivery in a significant percentage of the cases.
In July 2018, Windtree announced that it had completed design verification of the new ADS, which would be used in Phase 3 studies. The bridging study using the new delivery technology is expected to enroll up to 90 premature infants receiving nCPAP for RDS and will compare a new, more intensive dosing regimen of Aerosurf, with higher and more frequent doses, compared to nCPAP alone.
Windtree Chief Medical Officer Steve Simonson said, “The current standard of care for administration of surfactant therapy is via an invasive process through a tube placed in the trachea. The trend in neonatology has been to use non-invasive respiratory support such as nasal continuous positive airway pressure (nCPAP) to treat RDS, but this method precludes the administration of surfactant therapy in a timely manner. Aerosurf allows for non-invasive delivery of aerosolized KL4 surfactant to premature infants receiving nCPAP. Data from our previous trials suggest that Aerosurf may reduce the incidence of nCPAP failure and the need for invasive intubation and delayed surfactant therapy.”
CEO Craig Fraser commented, “Enrollment of the first patient in our Phase 2b bridging study is an important step to build upon the positive results observed in the three previous Aerosurf Phase 2 clinical trials. If successful, this bridging study will validate our new ADS technology and transition the program to phase 3 clinical development. We believe Aerosurf represents a significant medical advancement in neonatology and look forward to the results from this bridging study.”
Read the Windtree Therapeutics press release.
