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Windtree Completes Enrollment in Its Phase 2 Study of Lucinactant (KL4 Surfactant) for COVID-19 Associated Lung Injury and Acute Respiratory Distress Syndrome

Data anticipated in first quarter 2022

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Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced it has completed enrollment in its Phase 2 study of lucinactant (KL4 surfactant) for patients with COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS). Data is anticipated in the first quarter of 2022.

The Phase 2 trial is a multicenter, single-treatment study in 20 patients designed to evaluate the safety and tolerability of lucinactant delivered as a liquid via the endotracheal tube in patients who are mechanically ventilated as a result of COVID-19 associated acute lung injury. Functional changes in gas exchange and lung compliance are also being measured.

“COVID-19 infection can cause serious lung injury resulting in acute respiratory distress syndrome (ARDS) where surfactant destruction and abnormalities may be a contributing factor. This initial pilot study is to determine if we can safely administer lucinactant as a surfactant replacement in these severely ill patients and to learn about potential dosing and respiratory benefits,” said Steve Simonson, MD, Chief Medical Officer of Windtree Therapeutics. “We are pleased to have completed enrollment and look forward to data from this trial in this first quarter of 2022.”

About Lucinactant
Lucinactant is a synthetic surfactant that is structurally similar to human pulmonary surfactant and contains a proprietary synthetic peptide KL4 (sinapultide), a 21-amino acid peptide that is designed to imitate the essential attributes of the human surfactant protein B (SP-B). SP-B is one of four known surfactant proteins and is the most important for proper functioning of the respiratory system. Surfactant is a natural lubricant produced by specialized cells in the lung called alveolar Type 2 cells and is critical for proper lung function. Surfactant helps keep the lungs from collapsing when exhaling and also improves oxygen transfer to the blood. Windtree’s lucinactant can be given either through an endotracheal tube or via a proprietary aerosolized delivery system. It has the potential to mitigate surfactant deficiency and inactivation that can occur as a result of infectious diseases that affect the lung, such as COVID-19. Preclinical data demonstrated that lucinactant may possess other beneficial properties, including modulation of the inflammatory process, antimicrobial properties, and lack of immunogenicity.

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