Windtree Therapeutics, Inc. Announces First Patient Dosed in its Phase 2 Clinical Trial Studying KL4 Surfactant in Acute Lung Injury in Adults with COVID-19
January 06, 2021 at 08:00 am EST
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Windtree Therapeutics, Inc. announced that it 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 (ARDS). 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 (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. 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 U.S. sites. Dosing will be through the endotracheal tube, with repeat dosing based on changes in oxygenation. Planned outcome measures include: physiologic response - Oxygenation Index (OI), 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 (ADS) 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, Inc. is a biotechnology company. The Company is focused on advancing early and late-stage therapies for critical conditions and diseases. The Companyâs portfolio of product candidates includes istaroxime, a Phase II candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, pre-clinical SERCA2a activators for heart failure and VAR-101 and VAR-102, pre-clinical precision atypical protein kinase C iota (aPKCi) inhibitors that are being developed for potential in rare and broad oncology applications. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum, enhancing calcium reuptake from the cytoplasm. It also has a licensing business model with partnership out-licenses in place.
Windtree Therapeutics, Inc. Announces First Patient Dosed in its Phase 2 Clinical Trial Studying KL4 Surfactant in Acute Lung Injury in Adults with COVID-19