Windtree announces FDA acceptance of IND application for Phase 2 clinical trial studying KL4 surfactant in acute lung lesions in adults with COVID-19

The SARS-CoV-2 virus that causes COVID-19 uses angiostene converting enzyme receptor 2 (ACE2) to enter host cells. ACE2 is a surface molecule on type 2 alveolar cells of the lungs. Type 2 cells are guilty of surfactant production in the lung. Type 2 cell damage or loss and COVID-19-related viral pneumonia can lead to poor surfactant production leading to loss of lung compliance and poor fuel exchange. This increases the likelihood of ARDS which can manifest as respiratory failure and the need for mechanical ventilation. There is no approved medicine for ARDS, however, surfactant abnormalities are a known feature of the disease. The Company believes that its artificial surfactant KL4 possibly has the potential to alleviate surfactant deficiency and resist the widespread destruction of surfactant that can occur as a result of COVID-19 related lung injury.

“The KL4 surfactant has been studied in several preclinical models of acute lung lesions, adding highly pathogenic H5N1 viral pneumonia, and has been shown to have structural and favorable effects. In addition, past clinical experience in SED patients provides a basis on which we can evaluate the KL4 surfactant in acute lung lesions that possibly occur in COVID-19. The KL4 surfactant was safely administered to newborns and adults with various surfactant deficiency conditions,” said Steve Simonson, MD, Medical Director of Windtree Therapeutics. Before reading the KL4 surfactant in patients with COVID-19 with acute lung injury, the lung serves to facilitate recovery and decrease the need for mechanical ventilation.

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