Windtree Therapeutics has announced that a lung deposition study in cynomolgus macaques showed that its proprietary aerosol delivery system (ADS) delivered KL4 surfactant uniformly to all regions of the lung. The ADS is being developed to deliver Windtree’s Aerosurf inhaled lucinactant, which is in Phase 2 development for the treatment of respiratory distress syndrome (RDS) and which recently received Fast Track designation from the FDA.
According to the company’s website, the ADS system works “by pumping KL4 surfactant through a heated capillary, after which the aerosol cools and slows in velocity, yielding a dense aerosol with a defined particle size suitable for respiration.”
Windtree President and CEO Craig Fraser said, “These study results confirm the ability of our aerosol delivery technology to overcome the barriers of successfully aerosolizing and delivering a surfactant with particle sizes appropriate for deep lung delivery with uniform distribution across all regions of the lung. These results not only support the premise of our Aerosurf RDS program, but also complement the clinical evidence seen in our phase 2a trial in premature infants 29 to 34 week gestational age and provide further insight into other potential applications of this novel technology in the future.”
Senior VP and Chief Development Officer Steve Simonson commented, “We are extremely pleased with the results of this study because, along with other work we have done, it serves as yet another validation of the potentially transformational capabilities of our ADS device, which aerosolizes our KL4 surfactant in a consistent and controlled flow and delivers it throughout the lungs to the areas where a surfactant needs to reach to produce its beneficial effects.”
Read the Windtree Therapeutics press release.
