Discovery Laboratories has announced that data from a Phase 2a clinical trial of Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants show that the novel delivery technology performed acceptably and that Aerosurf was safe and well tolerated.
During the study, the effects of three escalating doses of the surfactant delivered by the company’s novel capillary aerosol generator (CAG) to infants receiving nasal continuous positive airway pressure (nCPAP) were compared to nCPAP alone.
According to the company, the incidence of adverse events was comparable in both the treatment and control groups and no upward trend in the incidence of adverse events was observed over increasing doses of Aerosurf. Measurement of gas exchange parameters indicated that the surfactant reached the lungs.
Discovery Labs Chief Development Officer Steve Simonson said, “The ability to administer surfactant without invasive endotracheal intubation in the management of premature infants with RDS would represent a significant medical advancement. We are encouraged by the results from this Aerosurf Phase 2a clinical trial as it represents a positive indication that our technology has the potential to achieve this goal. While the trial was designed as a safety study and the number of patients was limited, the results suggest that the company’s combination drug/device product has the ability to deliver aerosolized KL4 surfactant to the lungs of premature infants with RDS.”
Given the positive results from this trial, the company said, it will move forward with the Phase 2 program, with plans to complete two more Phase 2a studies and a Phase 2b study by mid-2016. Earlier this year, Discovery Labs said that it was restructuring its business to focus on Aerosurf development.
Read the Discovery Labs press release.
