Discovery Laboratories has announced additional data from its Phase 2a trials of Aerosurf aerosolized surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants 29 to 34 week gestational age. that are receiving nasal continuous positive airway pressure (nCPAP). The company said that the data are “encouraging” and demonstrate that Aerosurf “may decrease nCPAP failure and the need for intubation” in these infants. Data from an initial Phase 2a study were announced in May 2015.
According to the company, infants receiving nCPAP alone had nCPAP failure rates of 53%, while infants in the 45 and 60 minute Aerosurf dose groups had only a 33% nCPAP failure rate. Discovery Labs confirmed that it is now advancing Aerosurf into Phase 2b, as it said in a recent update, with an initial trial in premature infants 29 to 32 week gestational age focused on those dose groups.
Discovery Labs Chief Development Officer Steve Simonson said, “Premature infants with RDS are born with immature lungs and are frequently unable to produce their own endogenous surfactant for up to 48 to 72 hours of life. With Aerosurf, we potentially have an opportunity to administer aerosolized KL4 surfactant non-invasively to support premature infants until they are able to produce their own surfactant. The data from the Phase 2a program to date are very encouraging. We are seeing signals that suggest our goal of reducing nCPAP failures and intubations with Aerosurf appears achievable. If we are successful, we believe Aerosurf will represent a transformational change in the management of RDS.”
Read the Discovery Labs press release.
