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Discovery Laboratories commences phase 2b clinical trial of AEROSURF.

M2 EQUITYBITES-December 30, 2015-Discovery Laboratories commences phase 2b clinical trial of AEROSURF

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Discovery Laboratories Inc (NASDAQ: DSCO), a biotechnology company focused on developing aerosolised KL4 surfactant therapies for respiratory diseases, has started its AEROSURF phase 2b clinical trial in premature infants 26 to 32 weeks gestational age receiving non-invasive nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome, it was reported yesterday.

The trial is aimed at assessing premature infants receiving aerosolised KL4 surfactant (including potentially repeat doses) compared to nCPAP alone. Two dose groups will be assessed. The main aim of the trial is to demonstrate evidence of efficacy and, if successful, inform the design of a phase 3 clinical program.

Steve Simonson, MD, Discovery Labs' chief development officer, said, 'Currently, surfactant therapy is primarily administered to premature infants with RDS via invasive endotracheal intubation. The trend in neonatology is to use less- or non-invasive methods to treat RDS but these preclude the administration of surfactant therapy in a timely manner. AEROSURF allows for non-invasive delivery of aerosolised KL4 surfactant to premature infants receiving nCPAP. The initiation of the phase 2b trial is an important next step to build upon the results observed in our recently completed phase 2a clinical trials in premature infants 29 to 34 weeks GA. Data from these trials are encouraging and suggest that AEROSURF may reduce the incidence of nCPAP failure and the need for intubation and delayed surfactant therapy. If this result is confirmed as we advance our development program, AEROSURF could represent a significant medical advancement in neonatology.'

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Publication:M2 EquityBites (EQB)
Date:Dec 30, 2015
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