WARRINGTON, Pa., April 19, 2021 /PRNewswire/ -- Windtree
Therapeutics, Inc. (NasdaqCM: WINT) ("Windtree" or the "Company"),
a biotechnology and medical device company focused on advancing
multiple late-stage interventions for acute cardiovascular and
pulmonary disorders, today announced it has filed a Track One
prioritized application with the United States Patent and Trademark
Office (USPTO) for a patent stemming from an application it filed
previously under the Patent Cooperation Treaty (PCT). Under this
USPTO program, the new istaroxime patent is expected to receive
examination and final disposition within one year of priority
status being granted, rather than the customary three years of
examination anticipated by the USPTO for non-prioritized
examinations.
Windtree is taking steps to strengthen the istaroxime patent
estate since it is the Company's lead pipeline asset. "With such
high unmet need for patients in the disease areas we are studying
istaroxime, we are focusing on ensuring our patent estate has the
most protection possible. If we are successful in our clinical
studies and eventually gain regulatory approval, our plan is for
istaroxime to be well prepared and protected in the
commercialization stage," said Craig
Fraser, CEO and President of Windtree. Istaroxime is
currently being developed in early cardiogenic shock and in acute
heart failure (AHF).
Early cardiogenic shock is a life-threatening state of lack of
heart function and blood flow to vital organs that is associated
with high risk of mortality, despite intensive monitoring and
current treatments. Based on the need in this area, regulatory
precedent exists for an approval in shock settings based upon
improvements in blood pressure with an acceptable safety profile.
The Company is currently executing an international randomized
double blind placebo controlled study to assess the effect of
istaroxime in patients with early cardiogenic shock due to heart
failure. This study will include 60 patients (30 assigned to
istaroxime and 30 assigned to placebo) receiving study drug
infusion over 24 hours. The primary endpoint will evaluate systolic
blood pressure over six hours after initiating the infusion.
Secondary endpoints will include characterization of blood pressure
changes over 24 hours, the number of patients requiring rescue
therapy (vasopressors, inotropes or mechanical devices), assessment
of renal function and measures associated with safety and
tolerability.
After successfully completing positive phase 2a and phase
2b studies in acute heart failure,
the next steps in development are focused on optimizing therapy and
employing study enrichment strategies to create a strong phase 3
and partnership position. With adequate resources, we plan to
conduct an additional phase 2b
clinical trial that will enroll approximately 300 patients
globally. The trial will focus on enrolling acute heart failure
patients with low blood pressure and those who are diuretic
resistant, two of the specific patient populations that we believe
could particularly benefit from the unique profile and potential
ability of istaroxime to increase cardiac function, increase blood
pressure and improve renal function. This trial has been designed
to collect data on measures that may serve as primary endpoints in
a phase 3 clinical trial, and will potentially extend the infusion
time beyond 24 hours. The company is currently preparing for the
trial start and to secure full clinical funding for the trial with
a focus on business development and partnership.
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, AEROSURF®, 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 (ADS) 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.