Studying a Surfactant Therapy for ARDS and COVID-19 Lung Injury

Windtree Therapeutics is in a phase 2 clinical trial for its investigational therapy, Lucinactant, which produces a synthetic surfactant being studied for acute lung injury in patients with COVID-19 and acute respiratory distress syndrome (ARDS).

Warrington, PA-based Windtree Therapeutics, a biotechnology and medical device company, is studying its therapy, Lucinactant, in adults with acute lung injury with COVID-19 and ARDS.

Earlier this year, the company announced it had begun a phase 2 clinical trial for this therapy, which utilizes its synthetic KL4 surfactant therapy platform.

“Our surfactant has a peptide component that makes it very analogous to the surfactant proteins that occur naturally in the lung,” Steve Simonson, MD, chief medical officer, Windtree Therapeutics, said.

The initial study will evaluate changes in physiological parameters in COVID-19 patients who are intubated and mechanically ventilated for associated lung injury and ARDS. The study will establish the dosing regimen, tolerability, and functional changes in gas exchange and lung compliance after KL4 surfactant administration. The study will include up to 20 patients with COVID-19 and ARDS and on mechanical ventilation from 4 to 5 sites in the US.

SARS-CoV-2 uses the angiotensin-converting enzyme 2 (ACE2) receptor for entry into host cells. ACE2 is a surface molecule on alveolar type 2 cells in the lungs. The type 2 cells are the source of surfactant production in the lung. Damage or loss of type 2 cells and the viral pneumonia often associated with COVID-19 may result in impaired surfactant production and increased surfactant degradation. This process can result in decreased lung compliance and impaired gas exchange leading to increased risk for respiratory failure and ARDS requiring mechanical ventilation.

Windtree believes its synthetic KL4 surfactant may have the potential to mitigate surfactant deficiency, improve respiratory parameters and reduce the time a patient spends on mechanical ventilation and the number of days a patient spends in the ICU.

Contagion spoke to Simonson about Lucinactant’s mechanism of action, details about their phase 2 trial, and potentially identifying other less severe COVID-19 patients for surfactant therapy.