Discovery Laboratories has announced the initiation of a Phase 2b trial of Aerosurf aerosolized KL4 surfactant to treat respiratory distress syndrome (RDS) in premature infants. The trial, which is expected to enroll up to 250 patients will compare outcomes for infants receiving Aerosurf plus non-invasive nasal continuous positive airway pressure (nCPAP) to outcomes for those receiving nCPAP alone.
Discovery Labs Chief Development Officer Steve Simonson commented, “Currently, surfactant therapy is primarily administered to premature infants with RDS via invasive endotracheal intubation. The trend in neonatology is to use less- or non-invasive methods to treat RDS but these preclude the administration of surfactant therapy in a timely manner. Aerosurf allows for non-invasive delivery of aerosolized KL4 surfactant to premature infants receiving nCPAP. The initiation of the phase 2b trial is an important next step to build upon the results observed in our recently completed phase 2a clinical trials in premature infants 29 to 34 weeks GA. Data from these trials are encouraging and suggest that Aerosurf may reduce the incidence of nCPAP failure and the need for intubation and delayed surfactant therapy. If this result is confirmed as we advance our development program, Aerosurf could represent a significant medical advancement in neonatology.”
Read the Discovery Labs press release.
