Windtree Therapeutics Announces Reduction In Arrythmias In A New Study With Istaroxime And A Pure SERCA2a Activator
2024年1月3日 - 6:05AM
Windtree Therapeutics, Inc. (“Windtree” or the “Company”)
(NasdaqCM: WINT), a biotechnology company focused on advancing
late-stage interventions for critical cardiovascular disorders,
today announced new preclinical data on the Company’s lead product
candidate, istaroxime, and another preclinical pipeline drug
candidate, CVie-216, showing reductions in ventricular arrythmias
in a rat heart model of diabetes with restricted and restored
coronary blood flow induced injury. Istaroxime and CVie-216 are
each designed to act on pumps in the cardiac cells that are
important in calcium handling. Istaroxime is a dual mechanism of
action compound that has been shown to inhibit the sodium potassium
ATPase and activates SERCA2a. CVie-216 is designed to selectively
activate SERCA2a.
Nearly 300 patients with acute decompensated heart failure were
treated with istaroxime in three Phase 2 studies, including a study
that evaluated patients with early cardiogenic shock. In these
studies, istaroxime has not been associated with an increase in
clinically significant arrythmias, raising the potential for a new
therapy with substantial advantages over current rescue drug
therapies used to treat acute heart failure and cardiogenic shock.
Windtree is continuing to obtain data to evaluate the potential
benefits of SERCA2a activation on arrythmia risk in all ongoing
clinical trials. To further explore this potential benefit
associated with SERCA2a activation, Windtree conducted a study of
restricted and restored coronary blood flow induced injury in the
hearts of rats with diabetes that were infused with either
istaroxime, pure SERCA2a activator CVie-216 or placebo (control).
The rat model generated a reproducible incidence of ventricular
arrythmias. This study demonstrated a reduction in arrythmias in
the istaroxime and CVie-216 pretreated groups compared to the
control group. The Company plans to publish the results and is in
the process of pursuing additional intellectual property protection
based on these findings.
“This new data suggests that improving SERCA2a activity has the
potential to improve arrythmia risk as well as improve overall
cardiac function,” said Craig Fraser, CEO of Windtree Therapeutics.
“We expect to continue to obtain additional data in our ongoing
clinical trial to characterize the impact of our SERCA2a activation
with istaroxime on clinically significant arrythmias and we expect
to extend these observations with additional preclinical work with
the oral SERCA2a Activators.”
Arrythmias are irregular heartbeats that can impact the pumping
function of the heart. Patients with heart failure and
cardiomyopathy are at risk for arrythmias. Arrythmias in these
patients can be caused by their underlying cardiac disease or by
drugs used to treat the heart failure such as catecholamines.
Arrythmias can impair proper filling of the heart with blood and,
importantly, cardiac output to the body. Ventricular arrythmias are
particularly dangerous and can be fatal.
Innovative drugs have the potential to treat acute heart failure
and cardiogenic shock to improve cardiac function without
increasing the risk for arrythmias. Acute decompensation of heart
failure is responsible for approximately 1.3 million hospital
admissions in the U.S. and approximately 1.5 million in the EU. It
is the #1 cause of U.S. hospitalizations in patients >65 years
of age and is the most expensive Medicare diagnosis to treat.
Cardiogenic shock can be a severe presentation of heart failure
characterized by low blood pressure and inadequate blood flow to
vital organs. It has a mortality rate as high as 30-40% and
substantial morbidity in survivors. Istaroxime is administered
intravenously in the hospital where acute heart failure and
cardiogenic shock patients are treated. CVie-216 is in the
preclinical stage of development and has potential for intravenous
administration or oral (tablet) use in the out-patient setting in
chronic heart failure. Chronic heart failure affects approximately
6 million people (nearly 2% of the adult population) in the U.S.
The combined U.S., EU and Japan market has more than 18 million
patients with chronic heart failure.
About IstaroximeIstaroxime is a first-in-class
dual mechanism therapy designed to improve both systolic and
diastolic cardiac function. Istaroxime is a positive inotropic
agent that increases myocardial contractility through inhibition of
Na+/K+- ATPase with a complimentary mechanism that facilitates
myocardial relaxation through activation of the SERCA2a calcium
pump on the sarcoplasmic reticulum enhancing calcium reuptake from
the cytoplasm. Data from multiple Phase 2 studies in patients with
early cardiogenic shock or acute decompensated heart failure
demonstrate that istaroxime infused intravenously significantly
improves cardiac function and blood pressure without increasing
heart rate or the incidence of cardiac rhythm disturbances.
About Pure SERCA2a ActivatorsThese compounds
activate SERCA2a and Windtree Therapeutic’s research and
development program is evaluating these preclinical product
candidates, including oral and intravenous SERCA2a activator heart
failure compounds.
About Windtree Therapeutics, Inc.Windtree
Therapeutics, Inc. is advancing late-stage interventions for
cardiovascular disorders to treat patients in moments of crisis.
Using new scientific and 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 cardiogenic shock
and acute decompensated heart failure. Windtree’s heart failure
platform includes follow-on pre-clinical SERCA2a activator assets
as well. In pulmonary care, Windtree has focused on facilitating
the transfer of the KL4 surfactant platform, to its licensee, Lee’s
Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd.
Included in Windtree’s portfolio is rostafuroxin, a novel precision
drug product targeting hypertensive patients with certain genetic
profiles.
Forward Looking StatementsThis 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 success and advancement of
the clinical development programs for istaroxime 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, and other materials on a timely basis and in
sufficient amounts; risks relating to rigorous regulatory
requirements, including that: (i) the U.S. Food and Drug
Administration 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
that the Company may never realize the value of its intangible
assets and have to incur future impairment charges; 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; the rate and degree of market acceptance of the
Company’s product candidates, if approved; the economic and social
consequences of the COVID-19 pandemic and the impacts of
political unrest, including as a result of geopolitical tension,
including the conflict between Russia and Ukraine,
the People’s Republic of China and the Republic of
China (Taiwan), and the evolving events in Israel and Gaza,
and any sanctions, export controls or other restrictive actions
that may be imposed by the United States and/or other
countries which could have an adverse impact on the Company’s
operations, including through disruption in supply chain or access
to potential international clinical trial sites, and through
disruption, instability and volatility in the global markets, which
could have an adverse impact on the Company’s ability to access the
capital markets. These and other risks are described in the
Company’s periodic reports, including its 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.
Contact Information:Matt
Epsteinmepstein@kendallir.com
Windtree Therapeutics (NASDAQ:WINT)
過去 株価チャート
から 4 2024 まで 5 2024
Windtree Therapeutics (NASDAQ:WINT)
過去 株価チャート
から 5 2023 まで 5 2024