Phase 2a study results of Aerosurf for prevention of RDS in premature infants published

Discovery Laboratories, Inc. (Nasdaq:DSCO), announces the publication of results from its previously-conducted Phase 2a feasibility study of Aerosurf®, the Company's aerosolized KL4 surfactant, for the prevention of respiratory distress syndrome (RDS) in premature infants, in the May 2010 issue of the Journal of Aerosol Medicine and Pulmonary Drug Delivery in the study titled "An Open Label, Pilot Study of Aerosurf® Combined with nCPAP to Prevent RDS in Preterm Neonates" (Finer et al., Journal of Aerosol Medicine and Pulmonary Drug Delivery 2010).

Dr. Robert Segal, Senior Vice President and Chief Medical Officer of Discovery Labs commented, "We are extremely pleased that the Journal of Aerosol Medicine and Pulmonary Drug Delivery has published these data and made them more widely available to the medical community. We believe that Aerosurf holds the promise to significantly expand the use of surfactant therapy by providing neonatologists with a means of delivering KL4 surfactant in a less-invasive form, potentially avoiding the risks associated with endotracheal intubation and mechanical ventilation. This study played an important role in our Aerosurf development program, including our decision to license our proprietary capillary aerosol generating technology, which is better suited to effectively aerosolize our KL4 surfactant."

Phase 2a Trial Summary

The Phase 2a clinical trial was an open label, multicenter study to evaluate the feasibility, safety and tolerability of Aerosurf for the prevention of RDS in premature infants. The trial was conducted in the United States and enrolled 17 infants with a mean birth weight of 1,460 grams and a gestational age ranging between 28-32 weeks.  Aerosurf was administered to infants within 30 minutes of birth using a commercially-available aerosolization device (Aeroneb Pro®) via nCPAP over a three-hour duration. A proprietary nCPAP adapter was employed to optimize surfactant aerosol flow.

Key observations of the study included:

  • Twelve (71%) of the infants required a single dose of Aerosurf only.
     
  • All infants survived through the assessment period (day 28 of life).
     
  • Fifteen (88%) of the infants survived with no evidence of bronchopulmonary dysplasia (commonly known as BPD, a chronic lung disease) at day 28 of life.
     
  • Five (29%) of the infants required intubation and mechanical ventilation (commonly known as nCPAP failure).
     
  • Aerosurf was generally safe and well tolerated.

These data were previously presented at the 2006 Pediatric Academic Societies Annual Meeting and the 2007 Meeting of European Society of Pediatric Research.

SOURCE Discovery Laboratories, Inc.

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