WARRINGTON, Pa., Sept. 19, 2016 /PRNewswire/ -- Windtree
Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused
on developing aerosolized KL4 surfactant therapies for respiratory
diseases, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for
AEROSURF® (lucinactant for inhalation) for the treatment of
premature infants with respiratory distress syndrome (RDS).
AEROSURF is a novel, investigational combination drug/device
product that is being developed to deliver aerosolized KL4
surfactant to premature infants with RDS, potentially reducing the
need for invasive endotracheal intubation and mechanical
ventilation to administer surfactant therapy.
"This Fast Track designation for AEROSURF underscores the
significant need to reduce the use of invasive intubation and
mechanical ventilation, which are required to administer surfactant
therapy, but may result in serious complications and increase the
risk for other respiratory conditions," commented Craig Fraser, President and Chief Executive
Officer. "By enabling non-invasive delivery of our aerosolized KL4
surfactant, we believe that AEROSURF will address a serious unmet
medical need and potentially provide transformative clinical and
pharmacoeconomic benefits. We look forward to continuing our work
with the FDA to advance AEROSURF through the clinical development
and regulatory approval process, with the goal of bringing a
transformative therapy to treat premature infants in an expedited
time frame."
The Fast Track program was created by the FDA to facilitate the
development and expedite the review of new drugs that are intended
to treat serious or life-threatening conditions that demonstrate
the potential to address unmet medical needs. Drugs that receive
this designation benefit from more frequent communications and
meetings with FDA to review the drug's development plan including
the design of the proposed clinical trials, use of biomarkers and
the extent of data needed for approval. Drugs with Fast Track
Designation may qualify for priority review to expedite the FDA
review process, if relevant criteria are met.
AEROSURF is currently being studied in a phase 2b clinical trial
in premature infants 26 to 32-week gestational age receiving nasal
continuous positive airway pressure (nCPAP) for RDS. The phase
2b trial includes clinical sites in North
America, Europe and
South America.
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.
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 for AEROSURF, which may involve
time-consuming and expensive clinical trials, which 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, 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.
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SOURCE Windtree Therapeutics, Inc.