WARRINGTON, Pa., Aug. 8, 2016 /PRNewswire/ -- Windtree
Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company
focused on developing aerosolized KL4 surfactant therapies for
respiratory diseases, today announced that the Company
has been awarded a Phase II Small Business Innovation Research
Grant (SBIR) valued at up to $2.6
million from the National Heart, Lung, and Blood Institute
(NHLBI) of the National Institutes of Health (NIH) to support the
AEROSURF® phase 2b clinical trial in premature infants
26 to 32 week gestational age (GA) receiving nasal continuous
positive airway pressure (nCPAP) for respiratory distress syndrome
(RDS). Under the terms of the grant, the Company has initially been
awarded $1.0 million and, over the
next two years, may be awarded up to an additional $1.6 million through the completion of the phase
2b clinical trial and one-year patient follow-up. The Company had
previously been awarded a $1.9
million SBIR grant from the NHLBI in support of the AEROSURF
phase 2a clinical trial in premature infants 29 to 34 week GA which
was completed in late 2015.
"We appreciate the NIH's continued recognition of the importance
of our RDS research and support of our AEROSURF development
program," commented Craig Fraser,
Windtree's President and Chief Executive Officer. "We believe that
the NIH's decision to continue to support this program is the
result of encouraging results in the AEROSURF phase 2a trial in
premature infants 29 to 34 week gestational age. Our key focus for
2016 remains the rigorous and timely execution of the AEROSURF
phase 2 program while effectively managing existing cash resources
and this NIH funding contributes directly towards achieving these
objectives."
The Company is currently enrolling the AEROSURF phase 2b
clinical trial in premature infants 26 to 32 weeks GA receiving
nCPAP for RDS. The trial is a multicenter, randomized,
controlled study with masked treatment assignment in approximately
240 premature infants and is designed to evaluate the safety and
tolerability of aerosolized KL4 surfactant (including with
potential repeat doses) administered in two dose groups (25 and 50
minutes), compared to infants receiving nCPAP alone. The
following endpoints will be evaluated: time to nCPAP failure (the
need for intubation and delayed surfactant therapy), incidence of
nCPAP failure and physiological parameters indicating the
effectiveness of lung function. The trial is expected to be
conducted in up to 50 clinical sites in the North America, Europe and Latin America. Enrollment has
begun with premature infants 29 to 32 weeks GA, and will include
premature infants 26 to 28 weeks GA after completion of the ongoing
phase 2a clinical trial in this age group.
Research under this SBIR grant is being conducted by
Robert Segal, MD, Principle
Investigator at Windtree.
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.