On Mar. 24, 2020, Windtree Therapeutics announced it will study its proprietary KL4 surfactant to potentially mitigate the pulmonary effects of severe COVID-19 infection. The Company is actively pursuing several non-dilutive opportunities to fund this project, including government agencies and private foundations.

Windtree’s proprietary synthetic, peptide-containing KL4 surfactant is similar to human surfactant and has been approved by the U.S. Food and Drug Administration (FDA) in a previous liquid dose formulation for RDS in premature infants. Windtree has also developed an innovative Aerosol Delivery System which, in combination with KL4 surfactant, is being studied for non-invasive treatment of RDS.

The COVID-19 virus infects via angiotensin-converting enzyme 2 (ACE2) on cells in the lung which impair surfactant production, resulting in decreased lung compliance, and increased likelihood of needing mechanical ventilation. Lung fibrosis and severe interstitial changes occurring in these COVID-19 patients resemble those seen in premature infants who are initially ventilated due to respiratory distress syndrome (RDS) and later develop bronchopulmonary dysplasia (BPD) – a condition in which KL4 surfactant clinical data suggests potential benefit.

Pre-clinical and clinical evidence shows surfactant replacement therapy has the potential to improve lung function, oxygenation, lung compliance and decrease pulmonary inflammation. These beneficial effects could lead to potential clinical improvements such as decreased need for mechanical ventilation, decreased time on ventilator (freeing the devices for other patients) and possibly mortality.

Windtree’s proprietary synthetic, peptide-containing KL4 surfactant is similar to human surfactant and has been approved by the FDA in a previous liquid dose formulation for RDS in premature infants. Windtree has also developed an innovative Aerosol Delivery System (ADS) which, in combination with KL4 surfactant, is being studied for non-invasive treatment of RDS.

This program called AEROSURF, has been studied in three phase 2 trials in premature infants with RDS. KL4 surfactant has been widely studied across 17 clinical studies in approximately 2,500 patients with various related acute pulmonary syndromes. The Company also previously announced results of a National Institutes of Health (NIH) funded preclinical study of aerosolized KL4 surfactant demonstrating reduced lung inflammation and improved overall survival in a well-established animal model of highly pathogenic avian influenza.

To support the studies, the Company is actively pursuing multiple non-dilutive funding opportunities to fund this project through a variety of government agencies and private foundations. Additionally, the Company is working with Lee’s Pharma (our KL4 surfactant partner in Asia) in their efforts to potentially study patients in China.