Windtree Therapeutics' Aerosolized KL4 Surfactant Reduces Lung Inflammation and Improves Survival in a High-Pathogen Avian Influenza Preclinical Study

WARRINGTON, Pa., Feb. 16, 2017 /PRNewswire/ -- Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focusing on developing aerosolized KL4 surfactant therapies for respiratory diseases, announced today that data from a preclinical influenza study showed that aerosolized KL4 surfactant reduced lung inflammation and improved overall survival in a well-established preclinical animal model. The Company believes that these preclinical data add to a growing body of evidence that supports the role of KL4 surfactant as a potential medical intervention to reduce morbidity and mortality associated with both seasonal and pandemic influenza pneumonia.

"While we remain focused on the rigorous and timely execution of the AEROSURF^® phase 2 clinical program in premature infants with respiratory distress syndrome (RDS), we are encouraged by the results of this study in influenza as there is significant unmet need to protect the lungs in patients with severe influenza pneumonia," commented Craig Fraser, President and Chief Executive Officer. "A Phase I SBIR contract from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) provided us the opportunity to study the use of KL4 surfactant to reduce lung injury after exposure to a highly pathogenic influenza strain. We are grateful for the support provided by the NIH for this study as well as the previously announced preclinical study in the use of KL4 surfactant as a medical countermeasure to mitigate damage to lungs after radiation exposure. Windtree plans to seek additional funding from the NIH to support further exploration of aerosolized KL4 surfactant as a potential medical countermeasure for treating influenza-associated lung injury."

In this preclinical study, aerosolized KL4 surfactant was compared to treatment with a daily oral dose of an antiviral, oseltamivir, alone (Tamiflu^®, Genentech) and placebo controls. Ferrets were evaluated for clinical signs of influenza infection and lung histopathology changes, after virus exposure. Preselected animals underwent histopathological evaluation of their lungs on Day 5, or if they were moribund; lungs of all surviving animals were also evaluated at Day 14.

Analysis from this study indicate that KL4 surfactant treatment substantially improved survival and reduced lung injury from influenza infection both at Day 5 and Day 14 based on a histopathologic evaluation of the lungs. KL4-surfactant treated animals showed an 80 percent survival that was the same as those receiving the oseltamivir. This is in comparison to controls where only a 20 percent survival was seen. The KL4 surfactant treatment group also showed fewer clinical signs of influenza when compared with animals receiving oseltamivir.

"Though this is an early proof-of-concept study of aerosolized KL4 surfactant for treatment of a lethal flu strain, these data are especially encouraging as the NIH has stated that there is an urgent need to develop new therapeutic candidates that have the potential to prevent severe life-threatening complications of human influenza, improve patient outcomes, and provide more and better options for monotherapy and combination therapy with existing antivirals. These data represent progress toward a potentially effective and efficient therapeutic to prevent lung injury associated with influenza, particularly when highly lethal, pandemic strains are involved," said Dr. Robert Segal, Senior Vice-President, Clinical Development and Academic Affairs, Windtree Therapeutics. Dr. Segal, the study's principle investigator, conducted this research in collaboration with the Battelle Biomedical Research Center (BBRC), in West Jefferson, OH.

Influenza viruses are consistently responsible for an average of 20,000 deaths and over 100,000 hospitalizations per year in the United States, and up to 500,000 deaths world-wide annually. KL4 surfactant is being evaluated as a multi-use medical countermeasure (MCM) against a variety of threat agents affecting the lung including avian influenza. While KL4 surfactant is not a traditional antiviral drug, its properties as an exogenous surfactant replacement therapy to maintain alveolar patency, and to supplement inactivated surfactant in severely inflamed lungs, and its immune-modulatory properties supports the goals of developing therapeutic interventions with broad activity that target host factors involved in reducing lung injury and immunopathology.

This project has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500027C. The content of this press release is solely the responsibility of Windtree Therapeutics, Inc. and does not necessarily represent the official views of the National Institutes of Health or Battelle Biomedical Research Center.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree's proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.

Windtree's lead product candidate is AEROSURF^®, a novel, investigational drug/device product that combines the Company's proprietary KL4 surfactant and aerosolization technologies.  AEROSURF is being developed to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). Enrollment is ongoing in a phase 2b clinical trial in up to 240 premature infants 28 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS, comparing AEROSURF to infants receiving nCPAP alone. The phase 2b trial is a global trial with clinical sites in North America, Europe and Latin America.

For more information, please visit the Company's website at www.windtreetx.com.

Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties include those risks related to Windtree's aerosolized KL4 surfactant development programs,  including AEROSURF, which may involve time-consuming and expensive clinical trials that may be subject to potentially significant delays or regulatory holds, or fail; risks related to the development of aerosol delivery systems (ADS) and related components; risks related to the manufacture by contract manufacturers or suppliers of drug products, drug substances, ADS and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of the U.S. Food and Drug Administration or other regulatory authorities that 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 products; and other risks and uncertainties described in Windtree's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.

SOURCE Windtree Therapeutics, Inc.

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