Phase IIb trial initiated for Aerosurf (aerosolized KL4 surfactant) to treat respiratory distress syndrome- Discovery Laboratories

Discovery Laboratories has initiated its AEROSURF phase IIb clinical trial in premature infants 26 to 32 weeks gestational age (GA) receiving non-invasive nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS). The trial is designed to evaluate premature infants receiving aerosolized KL4 surfactant (including potentially repeat doses) compared to nCPAP alone. Two dose groups will be evaluated. The primary objective of the trial is to demonstrate evidence of efficacy and, if successful, inform the design of a phase III clinical programme.

Comment: Currently marketed respiratory surfactants are available only as liquid instillate formulations and their therapeutic use is limited to infants who are intubated and undergoing mechanical ventilation for the treatment of RDS. Aerosurf (aerosolized KL4 Surfactant Drug-Device product) represents the first potential opportunity to deliver a clinically-relevant dose of surfactant to RDS patients in aerosol form, without the need for either intubation or mechanical ventilation. By doing so, Aerosurf holds the promise to significantly expand the use of surfactant in paediatric respiratory medicine.

Comment: Esteve have licensed rights in Spain, Portugal, Greece and Italy from Discovery Laboratories.