Discovery Labs Says Key Objectives of Phase 2a Clinical Trial of AEROSURF Were Achieved
Benzinga 11 years ago
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Discovery Laboratories, Inc. (NASDAQ: DSCO) today reported top line data from its recently completed AEROSURF® phase 2a clinical trial in premature infants with respiratory distress syndrome (RDS). Key objectives of the study were achieved, including (1) the primary objective of demonstrating the safety and tolerability of a single exposure of aerosolized KL4 surfactant administered in three escalating inhaled doses to premature infants 29 to 34 week gestational age and receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone, and (2) establishing proof of concept for the Company's proprietary technology platform based on physiological data suggesting that aerosolized KL4 surfactant is being delivered into the lung of premature infants, and acceptable performance of the novel capillary aerosol generator (CAG) technology in the neonatal intensive care unit (NICU).
"The ability to administer surfactant without invasive endotracheal intubation in the management of premature infants with RDS would represent
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