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Discovery Labs Announces Completion of Enrollment in AEROSURF® Phase 2a Dose Expansion Trial Top-line Results Expected to be Released in Mid-November Company Expects to Initiate AEROSURF Phase 2b Clinical Trial in Fourth Quarter of 2015

WARRINGTON, Pa., Oct. 21, 2015 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that it has completed enrollment in the AEROSURF® phase 2a dose expansion clinical trial to assess the administration of higher doses of AEROSURF in premature infants 29 to 34 week gestational age (GA) with respiratory distress syndrome (RDS). With the completion of enrollment in this trial, the Company expects to initiate its AEROSURF phase 2b trial in the fourth quarter of 2015 beginning with premature infants 29 to 32 weeks GA.

The AEROSURF phase 2a dose expansion trial is designed to expand upon the knowledge gained in the initial phase 2a clinical trial, which assessed the safety and tolerability of a single exposure of three escalating (15, 30 and 45 minutes) inhaled doses of aerosolized KL4 surfactant to 48 premature infants 29 to 34 weeks GA receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone. All key objectives in the initial trial were met, including establishment of proof of concept based on physiological data suggesting that aerosolized KL4 surfactant is being delivered into the lung of premature infants. The dose expansion trial is a multicenter, randomized, open-label, controlled study in 32 premature infants, which is designed to evaluate the safety and tolerability of aerosolized KL4 surfactant administered in higher (60 and 90 minutes) doses in premature infants 29 to 34 weeks. Additionally, the Company continues to evaluate the physiological effects of aerosolized KL4 surfactant. The Company anticipates releasing top-line results of the dose expansion study and holding an investor conference call in mid-November.

"We are pleased to have achieved another milestone in our AEROSURF development program with the completion of...


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