Discovery Laboratories, Inc. (Nasdaq:DSCO), announced that new data regarding Surfaxin LSTM (its novel, lyophilized KL4 surfactant dosage form) were presented at the 2010 Pediatric Academic Societies (PAS) Annual Meeting. The two studies presented demonstrate that Surfaxin LS improves lung function and oxygenation while attenuating lung inflammation in the preterm lamb model of respiratory distress syndrome (RDS). The preterm lamb model is recognized by the neonatal scientific community as an acceptable and well-established animal model of RDS in human preterm infants. The PAS Annual Meeting is internationally recognized as the largest, most relevant medical meeting dedicated to pediatric research.
Dr. Robert Segal, Senior Vice President and Chief Medical Officer of Discovery Labs, commented, "Surfaxin®, our lead product for RDS, has demonstrated a very favorable clinical profile and could potentially be approved by the FDA in 2011 for the prevention of RDS in premature infants. We have also been working with leading neonatology research centers to characterize the pharmacologic profile of our novel lyophilized KL4 surfactant, our second generation surfactant product candidate that we refer to as Surfaxin LS. Our strategy for Surfaxin LS development is to build upon the Surfaxin clinical experience to create a best-in-class product with improved preparation and administration flexibility with the potential to improve clinical performance by reducing potentially unfavorable peri-dosing events."
The following studies were presented:
Lyophilized KL4 Surfactant Sustains Oxygenation and Attenuates Inflammation Versus Animal- Derived Surfactant Replacement Therapy (SRT) in Ventilated-Hyperoxic Respiratory Distress (RDS) Model; Marla R Wolfson, et al.
- The objective of this study was to compare lyophilized KL4 surfactant to commercially available animal-derived surfactants with regard to improvements in pulmonary function (lung compliance, functional residual capacity and ventilator support requirements), integrity of lung tissue structure (assessed histologically), and the potential impact on inflammatory mediators in preterm lambs with RDS.
- Compared with untreated controls, treatment with lyophilized KL4 surfactant resulted in significant improvements in pulmonary function (p < 0.05), significantly better microscopic lung tissue structure (p < 0.05), and a significant reduction in two potent inflammatory mediators: interleukin (IL) – 8 and myeloperoxidase (p < 0.05). Significant improvements in pulmonary function were observed in lambs treated with the animal-derived surfactants, Survanta® and Curosurf®, compared with controls (p < 0.05); however, oxygenation was significantly improved in lambs treated with lyophilized KL4 surfactant compared with those treated with comparator animal-derived surfactants (p < 0.05).
- The investigators concluded that lyophilized KL4 surfactant improved oxygenation and attenuated lung inflammation in preterm lambs with RDS to a greater extent than animal-derived surfactants. These data suggest that lyophilized KL4 surfactant may mitigate the progression of RDS to bronchopulmonary disease (BPD) and, as a lyophilized formulation, may expand flexibility of use and patient access.
Comprehensive Comparison of Poractant Alfa and Lyophilized KL4 Surfactant in a Preterm Lamb Model of Respiratory Distress Syndrome; Arlin B. Blood, et al
- The objective of this study was to compare the effects of lyophilized KL4 surfactant and poractant alfa (Curosurf) on pulmonary function and peri-dosing associated effects of surfactant administration in preterm lambs with RDS.
- Both surfactants significantly improved pulmonary function (p < 0.05). However, lambs treated with lyophilized KL4 surfactant required significantly lower mechanical ventilator pressures to maintain pulmonary function compared with Curosurf-treated lambs (p < 0.05).
- In contrast to lambs treated with lyophilized KL4 surfactant, lambs treated with Curosurf experienced significant reductions in heart rate and rapidly increased brain oxygenation during the peri-dosing period (p < 0.05).
- The investigators concluded that the lyophilized KL4 surfactant may enable ventilation at lower mean airway pressures which may reduce the incidence of chronic lung disease and as such may be an effective substitute for the currently marketed surfactant products.
Dr. Segal continued, "These two studies indicate that Surfaxin LS favorably improves lung physiology and attenuates lung inflammation, which may reduce the risk for chronic lung disease. Additionally, we believe that Dr. Blood's observations with respect to heart rate and brain oxygenation suggest that lyophilized KL4 surfactant may also support a reduction in potentially unfavorable peri-dosing events following surfactant administration. These observations, coupled with the flexibility and anticipated ease of use of a reconstituted, lyophilized product represent a potentially meaningful improvement in this class of drugs relative to currently marketed surfactants. We look forward to continued advancement of the Surfaxin LS program."
SOURCE Discovery Laboratories, Inc.