WARRINGTON, Pa., April 28, 2016 /PRNewswire/ -- Windtree
Therapeutics, Inc. (NASDAQ: WINT) today announced that data from
the AEROSURF® Phase 2a clinical program in premature infants 29 to
34 weeks gestational age (GA) with respiratory distress syndrome
(RDS) will be presented as a poster at the 2016 Pediatric Academic
Societies (PAS) Meeting to be held April
30 – May 3, 2016 in
Baltimore, MD.
The AEROSURF phase 2a clinical program in premature infants 29
to 34 week GA consisted of two multicenter, randomized, open-label,
controlled studies in a total of 80 premature infants receiving
nasal continuous positive airway pressure (nCPAP) for RDS.
The studies were designed to evaluate the safety and tolerability
of aerosolized KL4 surfactant administered in five dose groups (15,
30, 45, 60 and 90 minutes), compared to infants receiving nCPAP
alone. Overall, the safety and tolerability profile of the
AEROSURF-treated groups was generally comparable to the control
group. In addition, data suggest that AEROSURF may be
reducing the incidence of nCPAP failure (the need for intubation
and delayed surfactant therapy).
The PAS Meeting brings together thousands of pediatricians and
other health care providers united by a common mission: improve the
health and well-being of children worldwide. This international
gathering includes researchers, academics, as well as clinical care
providers and community practitioners. Presentations cover issues
of interest to generalists as well as topics critical to a wide
array of specialty and subspecialty areas. The PAS Meeting is
produced through a partnership of four pediatric organizations that
are leaders in advancement of pediatric research and child advocacy
- American Pediatric Society (APS), Society for Pediatric Research
(SPR), Academic Pediatric Association (APA), and American Academy
of Pediatrics (AAP).
About AEROSURF®
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). A phase 2b
clinical trial in up to 240 premature infants was initiated late
last year to study AEROSURF in premature infants 26 to 32-week
gestational age receiving nasal continuous positive airway pressure
(nCPAP) for RDS, compared to infants receiving nCPAP alone.
The phase 2b trial is a global trial with clinical sites in
North America, Europe and Latin
America. The Company remains on track to complete enrollment
in this trial by the end of 2016 and release top-line results in
the first quarter of 2017.
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 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, including those affecting Windtree
Therapeutics' ability successfully to secure required additional
capital when needed, complete its development programs, secure
regulatory approvals for its product candidates in the U.S. and
abroad, and realize the potential value and benefits of its RDS
product portfolio, are described in its filings with the Securities
and Exchange Commission, including its most recent reports on Forms
10-K, and any amendments thereto. Any forward-looking statement in
this release speaks only as of the date on which it is made.
Windtree Therapeutics assumes no obligation to update or revise any
forward-looking statements.
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SOURCE Windtree Therapeutics, Inc.