Windtree Announces Results from Its Phase 2 Study of Lucinactant for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and Lung Injury
Mar 22, 2022
The rationale for the study was that the SARS-CoV-2 virus causing COVID-19 uses the angiotensin-converting enzyme 2 (ACE2) receptor for entry into host cells. The ACE2 receptor is found on alveolar Type 2 cells in the lung. Type 2 cells are the source of pulmonary surfactant production. When these cells are infected and damaged, surfactant production is impaired, increasing the risk for respiratory failure as surfactant is necessary for the lungs to stay inflated and for proper gas exchange. Surfactant deficiency is known to contribute to the pathophysiology of ARDS, respiratory failure, and lung injury in patients on mechanical ventilation.
The Phase 2 trial was designed to assess feasibility, safety, and tolerability of administration of reconstituted lyophilized lucinactant in these critically ill patients. The multicenter, single-arm study enrolled 20 critically ill patients who were intubated and on mechanical ventilation due to severe COVID-19 associated ARDS. Patients received lucinactant as a liquid via the endotracheal tube assessing safety and tolerability of the administration procedure and of the drug. Oxygenation and other physiological responses were also measured. Study sites were in the
Key findings from the study were:
- The trial demonstrated that intratracheal administration of reconstituted lyophilized lucinactant was generally safe and well tolerated and could be safely administered to critically ill, mechanically ventilated patients with severe COVID-19 associated ARDS.
- Compared to earlier trials in non-COVID-19 ARDS where patients were administered SURFAXIN®, a different formulation of lucinactant approved to treat premature neonates with RDS, it appeared reconstituted lyophilized lucinactant was easier and faster to administer and was associated with fewer peri-dosing side effects that commonly occur when liquid surfactants are administered in the airway. This apparent difference may be due to reconstituted lyophilized lucinactant having substantially lower viscosity than SURFAXIN®.
- Oxygenation and other physiological outcomes were generally stable or improved in these critically ill patients. Only a few patients received multiple doses of surfactant, suggesting that the amount of surfactant delivered was at the low end of the dose response curve.
- The results in this study support the feasibility of this treatment approach to develop a potential treatment for critically ill patients with severe ARDS due to COVID-19 or other causes.
“We are pleased to report these study results which demonstrate the feasibility of lucinactant delivered as a liquid via the endotracheal tube in treating critically ill patients who are intubated and mechanically ventilated due to severe COVID-19 associated ARDS,” said
About KL4 Surfactant Platform Programs
The Company has been supporting Lee’s (HK) in its development of the KL4 surfactant platform in
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 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 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 because of infectious diseases and inflammation in 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.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company's clinical trials, clinical trial timelines or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime, KL4 surfactant and the Company's other product candidates; the impacts of political unrest, including as a result geopolitical tension, including escalation in the conflict between Russia and
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Source: Windtree Therapeutics