WARRINGTON, Pa., March 22, 2021 /PRNewswire/ -- Windtree
Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical
device company focused on advancing multiple late-stage
interventions for acute cardiovascular and pulmonary disorders,
today announced the company is extending its collaboration with the
University of Milan-Bicocca for the discovery and development of
new SERCA2a compounds for the potential treatment of chronic and
acute human heart failure. Over the next 12 months, the
program will focus on the further characterization of Windtree's
SERCA2a activators and their interaction with SERCA2a and
associated regulatory proteins.
"We are delighted to extend our collaboration with the
scientific team at the University in Milan-Bicocca as we continue
to develop SERCA2a activators and understand their potential in
chronic and acute heart failure," said Steve Simonson, M.D., senior vice president and
chief medical officer. "The potential role of SERCA2a activation as
a treatment in heart failure (including heart failure with
preserved ejection fraction, or HFpEF) has been recognized but
successful intervention at this target has been elusive. By
utilizing a novel approach to SERCA2a activation, Windtree has
developed a portfolio of oral (and i.v.) SERCA2a activitors which
are progressing through pre-clinical testing and development. This
collaboration strengthens and extends the SERCA2a program and will
provide important scientific support to Windtree efforts to bring
these compounds forward."
Two aspects of SERCA modulation to be explored under the terms
of this collaboration include the antiarrhythmic potential and
modulation of smooth muscle activity resulting from SERCA2a
activation. Ahead of this preclinical research, Windtree is
advancing istaroxime, a first-in-class, dual action, luso-inotropic
agent for the treatment of acute decompensated heart failure.
Istaroxime is currently being assessed in a Phase 2 study in
patients experiencing early cardiogenic shock and has been granted
Fast Track designation by the FDA based on positive Phase 2a and
Phase 2b trial results in patients
with acute heart failure. Istaroxime has a dual mechanism of action
including inhibition of the sodium-potasium ATPase and activation
of SERCA2a.
About Windtree Therapeutics
Windtree Therapeutics,
Inc. is advancing multiple late-stage interventions for acute
cardiovascular and pulmonary disorders to treat patients in moments
of crisis. Using new clinical approaches, Windtree is developing a
multi-asset franchise anchored around compounds with an ability to
activate SERCA2a, with lead candidate istaroxime being developed as
a first-in-class treatment for acute heart failure and early
cardiogenic shock in heart failure. Windtree has also focused on
developing AEROSURF® as a non-invasive surfactant
treatment for premature infants with respiratory distress syndrome,
and is facilitating transfer of clinical development of
AEROSURF® to its licensee in Asia, Lee's HK,
while Windtree evaluates other uses for its synthetic KL4
surfactant for the treatment of acute pulmonary conditions
including lung injury due to viral, chemical and radiation induced
insults. Also, in its portfolio is rostafuroxin, a novel precision
drug product targeting hypertensive patients with certain genetic
profiles.
For more information, please visit the Company's website
at www.windtreetx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. The Company may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could,"
"might," "will," "should" or other words that convey uncertainty of
future events or outcomes to identify these forward-looking
statements. Such statements are based on information available to
the Company as of the date of this press release and are subject to
numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from the Company's
current expectations. Examples of such risks and uncertainties
include: risks and uncertainties associated with the ongoing
economic and social consequences of the COVID-19 pandemic,
including any adverse impact on the Company's clinical trials or
disruption in supply chain; the success and advancement of
the clinical development programs for istaroxime, KL4
surfactant and the Company's other product candidates; the
Company's ability to secure significant additional capital as and
when needed; the Company's ability to access the debt or equity
markets; the Company's ability to manage costs and execute on its
operational and budget plans; the results, cost and timing of the
Company's clinical development programs, including any delays to
such clinical trials relating to enrollment or site initiation;
risks related to technology transfers to contract manufacturers and
manufacturing development activities; delays encountered by the
Company, contract manufacturers or suppliers in manufacturing drug
products, drug substances, aerosol delivery systems and other
materials on a timely basis and in sufficient amounts; risks
relating to rigorous regulatory requirements, including that: (i)
the FDA or other regulatory authorities may not agree with the
Company on matters raised during regulatory reviews, 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 the Company's product candidates,
and (ii) changes in the national or international political and
regulatory environment may make it more difficult to gain
regulatory approvals and risks related to the Company's efforts to
maintain and protect the patents and licenses related to its
product candidates; risks related to the size and growth potential
of the markets for the Company's product candidates, and the
Company's ability to service those markets; the Company's ability
to develop sales and marketing capabilities, whether alone or with
potential future collaborators; and the rate and degree of market
acceptance of the Company's product candidates, if approved.
These and other risks are described in the Company's periodic
reports, including the annual report on Form 10-K, quarterly
reports on Form 10-Q and current reports on Form 8-K, filed with or
furnished to the Securities and Exchange Commission and available
at www.sec.gov. Any forward-looking statements that the
Company makes in this press release speak only as of the date of
this press release. The Company assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
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SOURCE Windtree Therapeutics, Inc.