Windtree to Pursue Clinical Study of Lung Injury Treatment in COVID-19 Patients

Windtree Therapeutics announced it is planning to 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.

"Patients with COVID-19 pneumonia may progress to severe respiratory failure requiring supplemental oxygen and mechanical ventilation. This acute lung injury, known as acute respiratory distress syndrome (ARDS), has no approved therapies and is associated with significant morbidity, mortality and healthcare resource utilization." said Steve Simonson, M.D., Senior Vice President and Chief Medical Officer of Windtree Therapeutics. "The COVID-19 virus infects the specific cells that make pulmonary surfactant and is believed to result in inadequate levels of functional surfactant. We believe this mechanism of injury may differentiate COVID-19 lung injury from other etiologies of ARDS and is the basis for a potentially important role for our KL4 surfactant. Numerous preclinical studies have shown positive effects of our KL4 surfactant in various models of severe lung injury and our clinical studies have demonstrated beneficial effects in respiratory distress syndrome in premature infants leading us to believe there may be potential to provide benefit in patients with severe COVID-19 lung injury."

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.

"Our Company is committed to help minimize the devastating impact of this virus. With the appropriate funding, we plan to initiate a pilot study to assess KL4 surfactant's ability to impact key respiratory parameters in ventilated COVID-19 patients. Depending on the results, we would be prepared to move forward in this indication very quickly," Craig Fraser, CEO of Windtree said.

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