Discovery Laboratories, Inc. announced that additional clinical data from its SELECT and STAR Phase 3 clinical trials of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants, were presented at the European Academy of Paediatrics Congress (Europaediatrics) in Barcelona, Spain.
These data demonstrate that Surfaxin-treated infants require significantly less re-intubation and experience improved key clinical outcomes compared to those treated with the animal derived surfactants, Survanta and Curosurf, the current market-leading products in the United States and Europe, respectively.
Recent data from Discovery's pivotal and supportive Phase 3 clinical trials, SELECT and STAR, demonstrate statistically significant reductions in re-intubation rates for Surfaxintreated infants as follows:
In a pooling of both studies, re-intubation rates were significantly lower for Surfaxin-treated infants compared with those treated with the animal-derived surfactants (34.2% vs. 43.9%, respectively; p = .005); In the SELECT trial's comparison of Surfaxin with Survanta, re-intubation rates were significantly lower for infants treated with Surfaxin (34.6% vs 42.8%, respectively; p = .014); In the STAR trial's comparison of Surfaxin with Curosurf, re-intubation rates were significantly lower for infants treated with Surfaxin (32.7% vs. 47.2%, respectively; p = .048)
Premature babies are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen, resulting in RDS. These babies often require endotracheal intubation - a breathing tube inserted in the infant's fragile airway - allowing for surfactant administration and respiratory support via mechanical ventilation. This breathing tube is removed when the infant no longer requires ventilatory support.
Unfortunately, many infants suffer a relapse in respiratory function that requires reintubation. This repeated invasive intubation and prolonged mechanical ventilation increases the risk of airway damage, hospital stay, chronic lung disease (also known as bronchopulmonary dysplasia, BPD), and death. In addition, endotracheal intubation and prolonged mechanical ventilation dramatically increases the cost of treating these babies.
These data were presented at Europaediatrics by Fernando Moya, M.D., Chair of the SELECT study Steering Committee and Director of Neonatology at the Coastal Area Health Education Center, North Carolina. Dr. Moya commented, "According to the Centers for Disease Control and Prevention, the most frequent cause of infant death in the United States is preterm birth. Premature infants often have lung dysfunction usually associated with RDS. Current surfactant treatment options for RDS are limited to animal derived surfactants harvested from bovine (cow) and porcine (pig) sources. Surfaxin has already shown a robust survival benefit compared to these animal derived surfactants.
These new data are particularly important as they now show that Surfaxin decreases reintubation procedures, which are associated with long-term respiratory morbidity, compared with animal derived alternatives. Any therapy capable of improving odds for survival while reducing complications associated with prematurity represents a potential significant advancement in neonatal care."
Dr Moya also presented previously reported long-term clinical data derived from a pooled analysis combining data from the SELECT and STAR trials in a symposium at Europaediatrics entitled "Surfactant Therapy; Past, Present and Future." These data demonstrated that premature infants treated with Surfaxin experienced a significant survival benefit through one year of life compared with the currently available animal derived surfactants.
Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative to the animal-derived and non-protein containing synthetic surfactants. Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and maintain proper airflow through the respiratory system. Surfaxin, an investigational drug, is currently the subject of an Approvable Letter from the FDA for the prevention of RDS in premature infants.
RDS afflicts tens of thousands of premature infants in the United States each year, with a global at-risk population in excess of 500,000 infants. Approximately 75,000 infants are treated with surfactants in the United States annually.