Discovery Laboratories has initiated a phase IIB study to evaluate AEROSURF in premature infants receiving noninvasive nasal continuous positive airway pressure (nCPAP).
Discovery Laboratories Inc (DSCO – Snapshot Report) announced that it has initiated a phase IIb study, which will evaluate its aerosolized KL4 surfactant, AEROSURF, in premature infants 26 to 32 weeks of gestational age (GA) receiving noninvasive nCPAP for respiratory distress syndrome (RDS).
The multicenter, randomized, controlled phase IIb study will compare the addition of AEROSURF to nCPAP in premature infants with nCPAP alone. Two dose strengths of AEROSURF will be evaluated. Positive data from the phase IIb study will enable the company to initiate a phase III study on the candidate.
We note that the initiation of the phase IIb study follows closely on the heels of release of data from a recently completed phase IIa study in premature infants 29 to 34 weeks GA. Data from the phase IIa study was encouraging and hinted at the ability of AEROSURF in reducing the incidence of nCPAP failure and the need for intubation and delayed surfactant therapy.