Nov. 12, 2013
/PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's investigational new drug (IND) 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.
About AEROSURF ®
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). AEROSURF could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.
About Respiratory Distress Syndrome (RDS)
RDS is a condition in which premature infants are born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen. Premature infants born prior to 37 weeks gestation have not fully developed their own natural lung surfactant and therefore need treatment to sustain life. RDS is experienced in approximately half of the babies born between 26 and 32 weeks gestational age. The incidence of RDS approaches 100 percent in babies born less than 26 weeks gestational age. RDS can result in long-term respiratory problems and death.