AEROSOLIZED LUCINACTANT (KL4 SURFACTANT FOR INHALATION)
AEROSURF® is drug-device combination that incorporates lucinactant to treat premature infants suffering from respiratory distress syndrome a complication with preterm births due to the infant’s lungs lacking endogenous surfactant. AEROSURF® allows for the non-invasive delivery of surfactant in order to avoid the well-known complications associated with invasive administration, intubation and ventilation using its proprietary aerosol delivery system (ADS). Data from Phase 2 trials have demonstrated that AEROSURF has the potential to improve lung function in premature infants with RDS.
Surfactant is an essential component of healthy lungs to keeps them fully expanded and without a sufficient amount of surfactant, lungs collapse, taking more effort to breathe. Infants born prematurely do not make adequate surfactant, so replacement therapy is often used until the infant is developed enough to produce its own.
Surfactant therapy is a treatment for respiratory distress syndrome and the primary therapy to address an underlying surfactant deficiency. Current delivery of animal-derived surfactant in these infants is highly invasive by way of endotracheal intubation frequently along with mechanical ventilation, each of which may result in serious respiratory conditions and other complications. Intubation is associated with airway trauma and clinical instability that can extend beyond the respiratory system such as increased intracranial pressure and risk for brain injury. Mechanical ventilation is associated with ventilator-associated lung injury, chronic lung disease and increased risk of infection. Invasive therapy and respiratory support increases the risk of developing bronchopulmonary dysplasia (BPD), a serious chronic lung condition that can be accompanied by neurodevelopmental complications. The current alternative to invasive surfactant therapy is a non-invasive method, nasal continuous positive airway pressure (nCPAP), which is unsuccessful in many infants. Since nCPAP does not address the underlying cause of RDS, namely surfactant deficiency, many premature infants respond poorly to nCPAP (typically within the first 72 hours of life) and may require intubation and delayed surfactant therapy (an outcome referred to as nCPAP failure)
AEROSOL DELIVERY SYSTEM (ADS) TECHNOLOGY PLATFORM
Windtree’s proprietary ADS is designed to aerosolize lucinactant. An aerosol is created by passing the KL4 surfactant through a heated capillary under pressure, after which the aerosol cools and slows in velocity, yielding a dense aerosol with a defined particle size suitable for respiration in infants.
Windtree has demonstrated that its ADS is able to produce aerosolized lucinactant with the following important characteristics:
· Full retention of the surface-tension lowering properties of a functioning surfactant necessary to restore lung function and maintain patency of the conducting airways.
· Full retention of the surfactant composition upon aerosolization.
· Drug particle size believed to be suitable for deposition into the lung.
AEROSURF® CLINICAL FINDINGS
AEROSURF has been studied in nearly 400 preterm infants with RDS in three Phase 2 trials. Phase 2 data to date demonstrate that AEROSURF®, when added to nCPAP demonstrated the ability to improve lung function in premature infants with RDS by improving respiratory parameters, decrease nCPAP failure (the need for intubation and mechanical ventilation), and reduce the rates of BPD. Additionally, AEROSURF has a favorable safety profile.
In 2021, we plan to continue supporting Lee’s Pharmaceuticals (HK) efforts to plan, fund and initiate in Asia the Phase 2b bridging study needed to advance AEROSURF to Phase 3 clinical trials.