WARRINGTON, Pa.,
Nov. 28, 2016 /PRNewswire/
-- Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology
company focused on developing aerosolized KL4
surfactant therapies for respiratory diseases, today
announced the Company's previously released AEROSURF® (lucinactant
for inhalation) phase 2a data was presented at the
6th International Congress of European Neonatal and
Perinatal Societies (UENPS) held in Valencia, Spain by Jan
Mazela, M.D., PhD, Poznan University of Medical Sciences.
The data demonstrate that AEROSURF administered non-invasively via
nasal continuous positive airway pressure (nCPAP) in premature
infants 29-34 weeks gestational age (GA) with respiratory distress
syndrome (RDS) was generally safe and well tolerated and
may be reducing the incidence of nCPAP failure (the need for
invasive intubation and delayed surfactant therapy).
Additionally, the abstract received the UENPS Congress 2016
Best Abstract Award.
"We are very pleased with the safety and tolerability seen
with AEROSURF in the phase 2 program thus far and are encouraged by
the reduction of nCPAP failures seen when using AEROSURF in preterm
neonates 29-34 weeks GA," stated Steve
Simonson, M.D, Senior Vice President and Chief Development
Officer. "Though further study is required, if
we are successful, we believe AEROSURF will represent a
transformational change in the management of
RDS. We are very pleased that UENPS acknowledged
this work with the Best Abstract Award at its Congress. We
believe this award recognizes the importance to the neonatal
community of pursuing a non-invasive treatment for RDS and
acknowledges the quality of the study and the potential of
AEROSURF."
About AEROSURF® (lucinactant for inhalation) and
KL4 Surfactant
Pipeline
Windtree's lead product candidate is AEROSURF® (lucinactant for
inhalation), a novel, investigational combination 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 to study AEROSURF administered to
premature infants 29 to 32 week GA receiving nasal continuous
positive airway pressure (nCPAP) for RDS, compared to infants
receiving nCPAP alone. The phase 2b trial is a blinded,
global trial with clinical sites in North
America, Europe and Latin America and will study up
to 240 infants. Additionally, the company is currently
conducting a separate phase 2a trial in 26-28 week GA
infants.
In addition to the study of RDS, Windtree continues to
conduct, with support from the National Institutes of Health,
pre-clinical investigation of aerosolized
KL4 surfactant in various acute
lung injury conditions including radiation induced lung injury and
viral induced lung injury.
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 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-aerosurf-lucinactant-for-inhalation-phase-2a-data-presented-at-the-2016-international-congress-of-union-of-european-neonatal-and-perinatal-societies-300369148.html
SOURCE Windtree Therapeutics, Inc.