6 January 2021 - - US-based biotechnology and medical device company Windtree Therapeutics, Inc. (NASDAQ: WINT) has dosed the first patient in its Phase 2 clinical trial studying lucinactant in acute lung injury in adults with COVID-19 associated lung injury and acute respiratory distress syndrome, the company said.

Lucinactant is the company's synthetic KL4 surfactant that is structurally similar to human pulmonary surfactant.

The SARS-CoV-2 virus causing COVID-19 uses the angiotensin-converting enzyme 2 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.

There are no approved drug therapies for ARDS, yet surfactant abnormalities are a known characteristic of the condition.

The company 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 intensive care unit.

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 4-5 US sites.

Dosing will be through the endotracheal tube, with repeat dosing based on changes in oxygenation.

Planned outcome measures include: physiologic response - Oxygenation Index, lung compliance on the ventilator and clinical parameters including time on mechanical ventilation, days in intensive care unit and mortality (although this first study will not be powered for these measures). Recruitment is expected to take 3-6 months (depending on COVID-19 rates at study sites).

If the initial Phase 2 study results demonstrate adequate safety/tolerability and efficacy on physiological variables, Windtree may initiate two additional clinical trials.

One study would more fully assess the impact of KL4 surfactant on clinical endpoints such as time on mechanical ventilation, time in the ICU, mortality.

The second study would be to utilize the company's novel and proprietary Aerosolized Delivery System to aerosolize and deliver the KL4 surfactant noninvasively in COVID-19 patients that are at high risk of respiratory failure with an intent to avoid mechanical ventilation, a similar strategy to the company's respiratory distress syndrome studies in preterm infants.

Windtree Therapeutics is advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in moments of crisis.

Using new clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate istaroxime being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock in heart failure.