Discovery Labs Cleared For IIa/b Aerosurf Trial

Discovery Laboratories’ IND for Aerosurf has been cleared by the FDA, enabling the company to initiate its Phase II trial. The trial is expected to include two studies. The primary goal of the initial study, Phase IIa, is to evaluate the safety and tolerability of a single exposure of aerosolized KL4 surfactant drug product.  This study is planned as an escalating dose study evaluating three dose levels of aerosolized KL4 surfactant. The comparator is nCPAP alone. The study will be conducted in three centers in the U.S. and is expected to be completed by mid-2014.

The design of the Phase IIb study will be informed by the results of the IIa study. The primary objective of the Phase IIb study will be to determine optimal dose and to estimate the efficacy margin. Results of the study will inform the design of the Phase III efficacy and safety study.  Phase IIb is expected to be conducted in multiple centers and completed by mid-2015.

Aerosurf is a novel investigational drug-device combination product being developed to deliver Discovery Labs’ KL4 surfactant in aerosolized form to premature infants with respiratory distress syndrome (RDS).