Windtree Therapeutics Announces the Start of Patient Dosing In Phase 2 SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock
December 18 2023 - 8:00AM
Windtree Therapeutics, Inc. (“Windtree” or the “Company”)
(NasdaqCM: WINT), a biotechnology company focused on advancing
late-stage interventions for critical cardiovascular disorders,
today announced that the Company recently enrolled the first
subject in its Phase 2 SEISMiC Extension Study of istaroxime in the
treatment of early cardiogenic shock. Study results are expected in
mid-2024.
Building upon the positive SEISMiC study results, the Extension
Study is expected to enroll up to 30 subjects with the objective to
evaluate a longer dosing cycle of istaroxime, a novel
first-in-class therapy that is designed to improve systolic
contraction and diastolic relaxation of the heart while also
increasing blood pressure. The study of hospitalized patients with
early cardiogenic shock (SCAI Stage B) due to acute heart failure
(AHF) will evaluate two dose regimens of istaroxime compared to
placebo. Subjects on istaroxime will receive infusions for up to 60
hours with one istaroxime group receiving a tapered decreasing dose
over time and the second istaroxime group receiving a consistent
lower dose. In the previous SEISMiC study in early cardiogenic
shock, patients were infused with drug or placebo for 24 hours. We
believe extending the dosing duration of istaroxime has the
potential to provide additional benefit and, along with dose
titration, is an important factor in determining the optimal dosing
regimen to study in a potential Phase 3 trial. The Extension Study
will also gather data to characterize the potential benefits of
SERCA2a activation in these patients, advancing the Company’s
clinical and regulatory position for potential Phase 3
readiness.
The Company is also progressing the start-up of a parallel study
in more severe, SCAI Stage C cardiogenic shock patients. SCAI Stage
C patients have low blood pressure and inadequate blood flow to
vital organs. The istaroxime cardiogenic shock SCAI Stage C study
is expected to enroll up to 20 subjects with SCAI Stage C
cardiogenic shock due to AHF. Multiple physiologic measures
associated with cardiac function, blood pressure and safety will be
assessed. The Company is targeting data from this study in a
similar timeframe as the SEISMiC Extension Study.
“The SEISMiC Extension Study builds upon the positive data from
our three Phase 2 studies in acute heart failure and early
cardiogenic shock and is expected to determine the best dosing
regimen for our anticipated Phase 3 program in cardiogenic shock,”
said Craig Fraser, Windtree's President and Chief Executive
Officer. “Along with data from more severe, SCAI Stage C
cardiogenic shock patients coming from a parallel study, program
results in mid-2024 are expected to contribute to finalizing our
strategy and design for Phase 3 clinical trials and our end of
Phase 2 discussions with FDA.”
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 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 the 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
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