Windtree's Aerosurf misses in Phase IIb for RDS

Windtree Therapeutics Inc. (OTCQB:WINT) reported top-line data from a blinded, international Phase IIb trial in 221 premature infants 28-32 weeks of gestational age with respiratory distress syndrome (RDS) showing that up to 2 repeat doses of 25 or 50 minutes aerosolized Aerosurf lucinactant plus nasal continuous positive airway pressure (nCPAP) each missed the primary endpoint of reducing nCPAP failure at 72 hours vs. nCPAP alone. Specifically, the rate of nCPAP failure for all treatment groups was 44%.

Windtree said the results were due “in large part to an unexpected rate of treatment interruptions." The company said treatment interruptions were primarily due to clogging of disposable cartridge filters. In 45 patients in the 50-minute cohort whose dosing was not impacted by device-related treatment interruptions, the nCPAP failure rate was 31%...