In the preclinical study, researchers compared Windtree’s aerosolized KL4 surfactant with a daily oral dose of oseltamivir, an antiviral, and placebo controls. Following exposure to the influenza virus, investigators evaluated the ferrets for clinical signs of infection and lung histopathology changes.
“While we remain focused on the rigorous and timely execution of the Aerosurf phase II clinical program in premature infants with respiratory distress syndrome, we are encouraged by the results of this study in influenza as there is significant unmet need to protect the lungs in patients with severe influenza pneumonia,” president & CEO Craig Fraser said in prepared remarks. “A Phase I SBIR contract from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health provided us the opportunity to study the use of KL4 surfactant to reduce lung injury after exposure to a highly pathogenic influenza strain. We are grateful for the support provided by the NIH for this study as well as the previously announced preclinical study in the use of KL4 surfactant as a medical countermeasure to mitigate damage to lungs after radiation exposure. Windtree plans to seek additional funding from the NIH to support further exploration of aerosolized KL4 surfactant as a potential medical countermeasure for treating influenza-associated lung injury.”
Analysis of the study’s data showed that treatment with Windtree’s KL4 surfactant substantially improved survival and reduced lung injury from influenza infection both at day 5 and day 14. Animals that were treated with Kl4 surfactant or oseltamivir had survival ratings of 80%, while the animals in the control arm had a 20% survival rate.
The KL4 group had fewer clinical signs of influenza compared to the oseltamivir group, Windtree reported.
“Though this is an early proof-of-concept study of aerosolized KL4 surfactant for treatment of a lethal flu strain, these data are especially encouraging as the NIH has stated that there is an urgent need to develop new therapeutic candidates that have the potential to prevent severe life-threatening complications of human influenza, improve patient outcomes, and provide more and better options for monotherapy and combination therapy with existing antivirals,” senior VP of clinical development and academic affairs, Dr. Robert Segal, added. “These data represent progress toward a potentially effective and efficient therapeutic to prevent lung injury associated with influenza, particularly when highly lethal, pandemic strains are involved.”