Discovery Laboratories announced that the U.S. Food and Drug Administration has cleared the company's investigational new drug application for AEROSURF and the company can initiate its phase 2 clinical program. The phase 2 clinical program is expected to include two studies. The primary goal of the initial study, phase 2a, 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 second study, phase 2b, will be informed by the results of the phase 2a study. The primary objective of the phase 2b study will be to determine optimal dose and to estimate the efficacy margin. Results of the phase 2b study will inform the design of the phase 3 efficacy and safety study. Phase 2b is expected to be conducted in multiple centers and completed by mid-2015.
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