Windtree completes recruitment in its Phase 2 study on


WARRINGTON, Pennsylvania, Feb. 01. 10, 2022 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing several late-stage interventions for acute cardiovascular and pulmonary disorders, announced today that it has completed enrollment in its Phase 2 study of lucinactant (surfactant KL4) for patients with COVID-19-associated lung injury and acute respiratory distress syndrome (ARDS). Data is expected in the first quarter of 2022.

The Phase 2 trial is a 20-patient, single-treatment, multicenter study designed to assess the safety and tolerability of lucinactant administered in liquid form via the endotracheal tube in mechanically ventilated patients following associated acute lung injury. to COVID-19. Functional changes in gas exchange and lung compliance are also measured.

“COVID-19 infection can cause severe lung damage leading to acute respiratory distress syndrome (ARDS) where surfactant destruction and abnormalities may be a contributing factor. This first pilot study aims to determine if we can safely administer lucinactant as a replacement for surfactant in these critically ill patients and to learn more about the potential dosage and respiratory benefits,” said Steve Simonson, MD, Medical Director of Windtree Therapeutics. “We are delighted to have completed recruitment and look forward to data from this trial during this first quarter of 2022.”

About Lucinactant
Lucinactant is a synthetic surfactant that is structurally similar to human lung surfactant and contains a proprietary synthetic peptide KL4 (sinapultide), a 21 amino acid peptide designed to mimic essential attributes of human surfactant protein B (SP-B). SP-B is one of the four known surfactant proteins and is the most important for the proper functioning of the respiratory system. Surfactant is a natural lubricant produced by specialized cells in the lungs called type 2 alveolar cells and is essential for proper lung function. Surfactant helps prevent the lungs from collapsing when exhaling and also improves the transfer of oxygen to the blood. Windtree’s lucinactant can be delivered either through an endotracheal tube or a patented aerosol delivery system. It has the potential to alleviate surfactant deficiency and inactivation that can occur as a result of infectious diseases that affect the lungs, such as COVID-19. Preclinical data has demonstrated that lucinactant may possess other beneficial properties, including modulation of the inflammatory process, antimicrobial properties, and lack of immunogenicity.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is advancing several late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in crisis. Using novel scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds capable of activating SERCA2a, with the lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock. Windtree’s heart failure platform also includes follow-on oral preclinical SERCA2a activator assets. In pulmonary care, Windtree focused on facilitating clinical development transfer of AEROSURF®, to its licensee in Asia, Lee’s HK. Windtree is also evaluating surfactant KL4 for the treatment of acute respiratory distress syndrome in COVID-19 patients. Windtree’s portfolio includes rostafuroxin, a new precision drug targeting hypertensive patients with certain genetic profiles.

Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Company may, in certain circumstances, use terms such as “predicted”, “believes”, “potential”, “proposed”, ” continues”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “could”, “will”, “should” or other words that reflect the uncertainty of future events or results to identify such forward-looking statements.These statements are based on information available to the Company as of the date of this press release and are subject to numerous 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 continued economic and social consequences of the VOC pandemic ID-19, including any adverse impact on the Company’s clinical trials, clinical trial delays or supply chain disruptions; the success and progress of clinical development programs for istaroxime, surfactant KL4 and the Company’s other product candidates; the Company’s ability to obtain significant additional capital as needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute its operating plans and budgets; the results, cost and timing of the Company’s clinical development programs, including delays in such clinical trials related to registration or site initiation; risks related to technology transfers to subcontractors and manufacturing development activities; delays experienced by the Company, contractors or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials in a timely manner and in sufficient quantities; risks related to stringent regulatory requirements, including that: (i) the FDA or other regulatory authorities may disagree with the Company on issues raised during regulatory reviews, may require significant additional activities, may not accept or may suspend or delay consideration of applications, or may not approve or limit the approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make more difficulty in obtaining regulatory approvals and the risks associated with the Company’s efforts to maintain and protect patents and licenses related to its product candidates; the risks that the Company may never realize the value of its intangible assets and may incur future impairment charges; risks relating to the size and growth potential of markets for the Company’s product candidates, and the Company’s ability to serve such markets; the Company’s ability to develop its sales and marketing capabilities, alone or with potential future employees; and the rate and degree of market acceptance of the Company’s product candidates, if approved. These and other risks are described in the Company’s periodic reports, including Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed or furnished to the Securities and Exchange Commission and available at Any forward-looking statements the Company makes in this press release speak only as of the date of this press release. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

Contact details:
Monique Kosse
LifeSci Advisors
212.915.3820 or [email protected]

Media contact:
Andrew Mielach
LifeSci Communications
646.876.5868 or [email protected]


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