Windtree Therapeutics said that it has completed design verification of a new version of its aerosol delivery system (ADS) for Aerosurf inhaled KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants and plans to use the new system in Phase 3 studies of the drug. The company said that Mack Medical is preparing to manufacture the new ADS.
According to the company, the new system is designed to overcome clogging problems experienced with the prototype delivery system, which Windtree blamed for the failure of a Phase 2b trial to meet its primary endpoint.
Windtree President and CEO Craig Fraser commented, “Completing design verification of the ADS represents a significant milestone for Windtree and the Aerosurf program. We have an extensive history evaluating our KL4 surfactant in RDS and multiple phase 2 clinical trials suggest that Aerosurf, when dosed as intended, produces a level of efficacy and safety that gives us confidence in the drug component of Aerosurf. Now, with our move from our prototype device to the new improved ADS, which has passed comprehensive performance and reliability testing, we believe that we have significantly advanced this aspect of our program. We are excited to utilize this new device in late-stage Aerosurf clinical development. As we noted in announcing a recent research collaboration, we also look forward to potentially leveraging our innovative drug and device technology beyond RDS.”
Senior VP and Chief Medical Officer Steve Simonson said, “Following ADS demonstrations with several of our clinician partners, we share their enthusiasm to be taking this ADS into the Neonatal Intensive Care Unit (NICU). This ADS was designed to be easier for NICU staff to use and potentially may allow for more rapid initiation of treatments, which could potentially have therapeutic benefit. We are looking forward to initiating our next clinical trial, which will be focused on gaining clinical experience with the new ADS, studying more intensive dosing and potentially confirming and extending the clinical effect seen when Aerosurf was delivered as intended in our phase 2b trial last year as a transition to planned phase 3 clinical development.”
Read the Windtree Therapeutics press release.
