Windtree to Pursue Clinical Study of Lung Injury Treatment in COVID-19 Patients with its KL4 Surfactant Therapy

WARRINGTON, Pa., March 24, 2020 /PRNewswire/ -- Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today announced it is planning to study its proprietary KL4 surfactant to potentially mitigate the pulmonary effects of severe COVID-19 infection. The Company is actively pursuing several non-dilutive opportunities to fund this project, including government agencies and private foundations.

"Patients with COVID-19 pneumonia may progress to severe respiratory failure requiring supplemental oxygen and mechanical ventilation. This acute lung injury, known as acute respiratory distress syndrome (ARDS), has no approved therapies and is associated with significant morbidity, mortality and healthcare resource utilization." said Steve Simonson, M.D., Senior Vice President and Chief Medical Officer of Windtree Therapeutics. "The COVID-19 virus infects the specific cells that make pulmonary surfactant and is believed to result in inadequate levels of functional surfactant. We believe this mechanism of injury may differentiate COVID-19 lung injury from other etiologies of ARDS and is the basis for a potentially important role for our KL4 surfactant. Numerous preclinical studies have shown positive effects of our KL4 surfactant in various models of severe lung injury and our clinical studies have demonstrated beneficial effects in respiratory distress syndrome in premature infants leading us to believe there may be potential to provide benefit in patients with severe COVID-19 lung injury."

The COVID-19 virus infects via angiotensin-converting enzyme 2 (ACE2) on cells in the lung which impair surfactant production, resulting in decreased lung compliance, and increased likelihood of needing mechanical ventilation. Lung fibrosis and severe interstitial changes occurring in these COVID-19 patients resemble those seen in premature infants who are initially ventilated due to respiratory distress syndrome (RDS) and later develop bronchopulmonary dysplasia (BPD) - a condition in which KL4 surfactant clinical data suggests potential benefit. Pre-clinical and clinical evidence shows surfactant replacement therapy has the potential to improve lung function, oxygenation, lung compliance and decrease pulmonary inflammation. These beneficial effects could lead to potential clinical improvements such as decreased need for mechanical ventilation, decreased time on ventilator (freeing the devices for other patients) and possibly mortality.

Windtree's proprietary synthetic, peptide-containing KL4 surfactant is similar to human surfactant and has been approved by the FDA in a previous liquid dose formulation for RDS in premature infants. Windtree has also developed an innovative Aerosol Delivery System (ADS) which, in combination with KL4 surfactant, is being studied for non-invasive treatment of RDS. This program called AEROSURF, has been studied in three phase 2 trials in premature infants with RDS. KL4 surfactant has been widely studied across 17 clinical studies in approximately 2,500 patients with various related acute pulmonary syndromes. The Company also previously announced results of a National Institutes of Health (NIH) funded preclinical study of aerosolized KL4 surfactant demonstrating reduced lung inflammation and improved overall survival in a well-established animal model of highly pathogenic avian influenza.

Craig Fraser, CEO of Windtree added, "Our Company is committed to help minimize the devastating impact of this virus. With the appropriate funding, we plan to initiate a pilot study to assess KL4 surfactant's ability to impact key respiratory parameters in ventilated COVID-19 patients. Depending on the results, we would be prepared to move forward in this indication very quickly."

To support the studies, the Company is actively pursuing multiple non-dilutive funding opportunities to fund this project through a variety of government agencies and private foundations. Additionally, the Company is working with Lee's Pharma (our KL4 surfactant partner in Asia) in their efforts to potentially study patients in China.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage, biopharmaceutical and medical device company focused on the development of novel therapeutics intended to address significant unmet medical needs in important acute care markets. Windtree has three lead clinical development programs spanning respiratory and cardiovascular disease states, including istaroxime, a novel, dual-acting agent being developed to improve cardiac function in patients with acute heart failure and cardiogenic shock; AEROSURF®, an innovative combination drug/device product candidate that is designed to deliver the Company's proprietary synthetic, peptide-containing surfactant noninvasively to premature infants with respiratory distress syndrome (RDS); and rostafuroxin, a novel precision drug product being developed to target hypertensive patients with certain genetic profiles in the important group of patients with resistant hypertension. Windtree also has multiple pre-clinical programs, including potential heart failure therapies delivered orally that are based on SERCA2a mechanism of action.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We 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 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: the Company's ability to continue as a going concern, the success and advancement of the clinical development programs for istaroxime and AEROSURF®; the Company's ability to secure significant additional capital as and when needed, the ability to access the debt or equity markets, risks related to Windtree's development programs,; risks related to technology transfers to contract manufacturers and manufacturing development activities, delays encountered by Windtree, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with Windtree on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree's product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to Windtree's efforts to maintain and protect the patents and licenses related to its products. These and other risks are described in the Company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

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