Discovery Laboratories has provided an update on its clinical development program for Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants. In March 2015, the company announced that it was restructuring to focus all its attention on Aerosurf.
According to Discovery Labs, enrollment in a Phase 2a expansion trial has been completed. The new trial involves 32 premature infants with RDS who are receiving nasal continuous positive airway pressure and will evaluate higher doses of Aerosurf than have been tested previously. The company announced results from the initial Phase 2a trial of Aerosurf in 48 premature infants in May 2014.
Discovery Labs also said that it plans to begin a Phase 2b trial in as many as 250 premature infants by the end of the year, with enrollment expected to be complete by the middle of 2016. The Phase 2b trial will compare two doses of Aerosurf plus nCPAP to nCPAP alone.
Discovery Labs President and CEO John G. Cooper said, “Our goal with Aerosurf is to provide neonatal medical practitioners with a means to administer aerosolized KL4 surfactant without invasive endotracheal intubation and, if we are successful, potentially transform the management of premature infants with RDS. The continued advancement of the Aerosurf clinical program and the steps taken in the third quarter to strengthen the company’s financial position represent important milestones towards achieving our goal.”
Read the Discovery Laboratories press release.
