Discovery Labs reports data from SURFAXIN preclinical study on RDS

May 10 2012

Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, reported that data from a preclinical study of SURFAXIN LS™ (lyophilized KL₄ surfactant) was recently published in the May issue of Pediatric Research.  The results of the study demonstrate that improvements in lung function following administration of SURFAXIN LS compares favorably to improvements in lung function following administration with Curosurf^®.  In addition, physiologic findings suggest that SURFAXIN LS may have a more favorable safety profile at the time of surfactant administration.  The study was conducted in the preterm lamb model of surfactant deficiency, a preclinical model recognized by the neonatal academic community as a well-established surrogate for human respiratory distress syndrome (RDS).  Curosurf is the current global, market-leading, animal-derived surfactant.  SURFAXIN LS, is being developed as a lyophilized dosage form of SURFAXIN^®, the first synthetic, peptide-containing surfactant approved by the U.S. Food and Drug Administration (FDA) for use in neonatal medicine.

The objective of the study was to compare the effects of SURFAXIN LS and Curosurf on pulmonary function, as well as the physiologic reactions to surfactant administration in preterm lambs with RDS.  The results of this study, which were previously presented to the 2010 Pediatric Academic Societies Annual Congress in May 2010 include:

• Both surfactants significantly improved pulmonary function (p < 0.05).  However, lambs treated with SURFAXIN LS required significantly lower mechanical ventilator pressures to maintain pulmonary function compared with Curosurf-treated lambs (p < 0.05). 
• In contrast to lambs treated with SURFAXIN LS, lambs treated with Curosurf experienced significant reductions in heart rate and rapidly increased brain oxygenation during the peridosing period (p < 0.05).
• The investigators concluded that SURFAXIN LS may enable ventilation at lower mean airway pressures, thereby potentially reducing the incidence of chronic lung disease, and as such may be an effective substitute for the currently-marketed surfactant products.

Dr. Russell G. Clayton, Senior Vice President, Research & Development of Discovery Labs commented, "The observations in this study suggest that SURFAXIN LS may reduce potentially unfavorable responses to surfactant administration.  These study results, when combined with the anticipated flexibility and ease of use benefits, suggest that SURFAXIN LS potentially represents a meaningful improvement in this class of drugs."

On March 6, 2012, the FDA granted marketing approval for SURFAXIN (lucinactant) for the prevention of RDS in premature infants at high risk for RDS.  SURFAXIN provides U.S. healthcare practitioners with an alternative to the animal-derived surfactants that today are the standard of care to manage RDS in premature infants. While SURFAXIN is stored and delivered in a liquid dosage form, SURFAXIN LS is stored as a powder and re-suspended to liquid form prior to use, eliminating the need for refrigerated storage.  Discovery Labs is implementing a development plan intended to gain marketing authorization for SURFAXIN LS in the U.S., the European Union and other major markets worldwide.

Dr. Clayton continued, "Our development strategy for SURFAXIN LS is to build upon the SURFAXIN clinical experience and advance a dosage form that will improve ease of use of surfactant administration for healthcare practitioners, as well as potentially prolong shelf life and eliminate the need for a temperature-controlled supply chain. We look forward to continued advancement of this important program, with the goal of initiating our clinical program in the second half of 2013."