Discovery Laboratories Inc. announced that data from a preclinical study using Surfaxin (lucinactant) in a well-established preterm lamb model of respiratory distress syndrome (RDS), demonstrated improved lung surfactant distribution as compared with Curosurf, the global market-leading animal-derived surfactant available today. The data were presented at the Pediatric Academic Society's annual meeting, which is internationally recognized as the largest, most relevant medical congress dedicated to paediatric research.
Data from the study "Comparison of two pulmonary surfactants administered to premature lambs with respect to cerebral blood flow, oxygenation and pulmonary distribution" were presented by Dr Arlin Blood from Loma Linda University School of Medicine. It has been hypothesised that a larger dose volume of surfactant could potentially result in more homogeneous distribution of surfactant throughout the lungs and may ultimately result in improved pulmonary and clinical outcomes.
The objective of the study was to compare Surfaxin, at a dose of 5.8 mL/kg (the dose used in the Surfaxin phase 3 clinical trials for RDS), with Curosurf, at a dose of 2.5 mL/kg (the dose prescribed in its label), in the well-established preterm lamb model. The lungs of preterm lambs closely resemble those of human lungs in development, structure and function and are most relevant to study the pathophysiology and treatment of RDS. The lambs were mechanically ventilated and received via endotracheal administration either Surfaxin or Curosurf.
The data showed that both surfactants significantly increased pulmonary compliance and tidal volume in this preterm lamb model of RDS without adversely affecting heart rate, blood pressure, or cerebral blood flow, irrespective of the dose volume employed. However, significantly more homogeneous lung distribution of Surfaxin (p < 0.001) was observed compared with Curosurf, as measured by pulmonary distribution of a mix of gold-labelled microspheres and surfactant.
Robert Segal, M.D., senior vice president and chief medical officer of Discovery Labs, commented, "Surfaxin was specifically formulated to provide both a smooth onset of action and a durable effect at a dose volume that would result in better lung distribution. The data from this study supports prior observations in other preclinical models that the clinical dose volume chosen for Surfaxin is likely to result in more uniform distribution throughout the lung. Of particular importance was the observation that there were no differences between Surfaxin and Curosurf following dosing in the stability of blood pressure, heart rate and cerebral blood flow, despite significantly different dose volumes of the surfactants studied."
Preterm infants are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen, leaving them at risk for RDS. Surfaxin is a synthetic, peptide-containing surfactant that is structurally similar to human lung surfactant, a substance produced naturally in the lung and essential for survival and normal respiratory function. Surfaxin represents a potential alternative to the currently-available animal-derived surfactants that are approved for preventing and treating RDS. Surfaxin is an investigational product that has not been approved by the US FDA or any other world health regulatory authorities. The data listed above include information that may be of interest to healthcare practitioners; however, the clinical relevance of this information has not been fully established.
The Pediatric Academic Societies (PAS) consists of the American Pediatric Society, the Society for Pediatric Research and the Ambulatory Pediatric Association. The PAS annual meeting is recognized as the largest, most prestigious meeting dedicated to pediatric research and education in the world and brings together scientists and physicians with expertise in all areas of paediatrics. More than 5,000 paediatric healthcare providers, including approximately 1,100 neonatologists attend this meeting annually.
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing.