According to recent Phase 2 study data reported by Windtree Therapeutics, Aerosurf (lucinactant for inhalation) administered noninvasively via nasal continuous positive airway pressure (nCPAP) in premature infants 29-34 weeks gestational age (GA) with respiratory distress syndrome (RDS) was generally safe and well tolerated and may be reducing the incidence of nCPAP failure (the need for invasive intubation and delayed surfactant therapy). The data was presented in an abstract at the 6th International Congress of European Neonatal and Perinatal Societies in Valencia Spain, where the abstract received the UENPS Congress 2016 Best Abstract Award.

Aerosurf (lucinactant for inhalation) is a novel, investigational combination drug/device product that combines the Windtree’s proprietary KL4 surfactant and aerosolization technologies. Aerosurf is being developed to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with RDS.

“We are very pleased with the safety and tolerability seen with Aerosurf in the phase 2 program thus far and are encouraged by the reduction of nCPAP failures seen when using Aerosurf in preterm neonates 29-34 weeks GA,” stated Steve Simonson, MD, Senior Vice President and Chief Development Officer.  “Though further study is required, if we are successful, we believe Aerosurf will represent a transformational change in the management of RDS.  We are very pleased that UENPS acknowledged this work with the Best Abstract Award at its Congress.  We believe this award recognizes the importance to the neonatal community of pursuing a non-invasive treatment for RDS and acknowledges the quality of the study and the potential of Aerosurf.”

Enrollment is ongoing in a phase 2b clinical trial to study Aerosurf administered to premature infants 29 to 32 week GA receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone.  The phase 2b trial is a blinded, global trial with clinical sites in North America, Europe and Latin America and will study up to 240 infants.  Additionally, the company is currently conducting a separate phase 2a trial in 26-28 week GA infants.

In addition to the study of RDS, Windtree continues to conduct, with support from the National Institutes of Health, pre-clinical investigation of aerosolized KL4 surfactant in various acute lung injury conditions including radiation induced lung injury and viral induced lung injury.