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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/windtree-therapeutics-aerosolized-kl4-surfactant-reduces-lung-inflammation-and-improves-survival-in-a-high-pathogen-avian-influenza-preclinical-study-300408538.html
SOURCE Windtree Therapeutics, Inc.