The Aerosurf trial evaluated aerosolized KL4 surfactant administered to premature infants 28 to 32 weeks gestational age in 2 dose groups with up to 2 repeat doses, compared to infants receiving nasal continuous positive airway pressure.
The trial evaluated incidence of nCPAP failure, time to nCPAP failure and physiological parameters indicating the effectiveness of lung function.
The inhaled therapy did not meet the primary endpoint of the study, which was reducing nCPAP failure at 72 hours.
The company said that the study failed to meet its primary endpoint because of the unexpected rate of treatment interruptions, after the disposable cartridge filters clogged in 23% of active enrollments.
Data analysis of patients in the 50-minute dose group, who were not impacted by device-related treatment interruptions, demonstrated a nCPAP failure rate of 31% compared to 44% in the control group.
The safety and tolerability profile of the Aerosurf therapy was comparable to the control, according to Windtree.
“While the results did not meet the planned top-line analysis, we are very encouraged to see that, when dose is delivered as intended, the 50 minute dose exhibited a positive treatment effect with a safety profile comparable to that of nCPAP and consistent with the results we obtained in our previously completed Phase IIa open-label clinical trial in similar gestational age infants,” chief medical officer Steve Simonson said in prepared remarks.
The company said it plans to work with regulatory bodies and determine a path forward with a Phase III plan, using its next-gen therapy which has been designed to mitigate the device-related treatment interruptions experienced in this trial.
“While analysis of data is ongoing, we believe we have achieved a number of important clinical objectives including providing evidence of a treatment effect in the higher dose and the potential to replicate desired results. We look forward to finalizing a regulatory and clinical plan to incorporate our next generation ADS, along with other learning’s from this trial, as we pursue a path that will allow us to advance Aerosurf into Phase III development,” CEO Craig Fraser added.