WARRINGTON, Pa., April 11, 2017 /PRNewswire/ -- Windtree
Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused
on developing aerosolized KL4 surfactant therapies for respiratory
diseases, today announced that the AEROSURF® (lucinactant for
inhalation) phase 2b independent Data Safety Monitoring Board
(DSMB) has completed its second and final interim safety review and
has recommended continuing the trial without modification. The
final DSMB interim review was convened following achievement in
mid-March 2017 of a pre-specified
patient enrollment milestone. In addition, the Company
reaffirms its plan to announce top-line results from the AEROSURF
phase 2b clinical trial in mid-year 2017.
"We are very encouraged by the AEROSURF safety and tolerability
profile to date and by the progress we have made with patient
enrollment in this trial," said Steve
Simonson, M.D., Senior Vice President and Chief Development
Officer of Windtree Therapeutics. "We believe that AEROSURF,
if successful, has the potential to transform the treatment of RDS
in premature infants. We look forward to completing this clinical
trial and sharing top-line results in mid-2017."
AEROSURF is a novel, investigational drug/device combination
product that combines the Company's proprietary KL4 surfactant and
aerosolization technologies. AEROSURF is being developed to
potentially reduce the need for endotracheal intubation and
mechanical ventilation in the treatment of premature infants with
respiratory distress syndrome (RDS). The AEROSURF phase 2b
clinical trial is a multicenter, randomized, controlled study with
masked treatment assignment in up to 240 premature infants
receiving nasal continuous positive airway pressure (nCPAP) for
RDS, and is designed to evaluate aerosolized KL4 surfactant
administered to premature infants 28 to 32 week gestational age in
two dose groups (25 and 50 minutes), with up to two potential
repeat doses, compared to infants receiving nCPAP alone. The key
objectives of this trial are to:
- evaluate efficacy by: (i) incidence of nCPAP failure, (ii) time
to nCPAP failure (defined as the need for intubation and delayed
surfactant therapy), and (iii) physiological parameters indicating
the effectiveness of lung function;
- define the dose regimen(s) for the planned phase 3 clinical
program
- provide an estimation of the expected efficacy margin of
AEROSURF treatment; and
- further characterize the AEROSURF safety profile
The trial is being conducted in approximately 50 clinical sites
in North America, Europe and Latin
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: the risk that the Company is a
development company with limited resources and no operating
revenues and its ability to continue as a going concern in the near
term is highly dependent upon obtaining results from the AEROSURF
phase 2b clinical trial in mid-2017 that are sufficient to support
a strategic or financing transaction; risks affecting the Company's
ability to raise capital, including pursuant to its universal shelf
registration statement, which permits only limited primary
offerings and expires in June 2017, a
pending delisting notice from The Nasdaq Market, a potential
shortage of available shares of common stock, and a complex capital
structure; risks affecting the timing of the Company's
planned clinical trials, which may involve time-consuming
and expensive clinical trials and be subject to potentially
significant delays or regulatory holds, or fail, and its ability
successfully to complete its development programs, secure
regulatory approval of its product candidates in the U.S. and in
markets outside the U.S.; risks related to development of
the aerosol delivery systems (ADS) and related components; risks
related to the manufacture of drug products, drug substances, ADS
and other materials on a timely basis and in sufficient amounts;
risks relating to rigorous regulatory requirements 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-announces-successful-completion-of-second-and-final-aerosurf-phase-2b-clinical-trial-interim-safety-review-300437905.html
SOURCE Windtree Therapeutics, Inc.