Windtree Therapeutics Announces Istaroxime Cardiogenic Shock SCAI Stage C Phase 2 Study Planned Interim Analysis Results Targeted for July 2025
- Previous Phase 2 studies in SCAI Stage B cardiogenic shock showed positive results
- Global trial scope across multiple regions (U.S., Europe, Latin America)
- Comprehensive study design with multiple important endpoints and measurements
- Results not expected until July 2025
- Still in Phase 2 testing, with Phase 3 trials yet to begin
- Efficacy in more severe SCAI Stage C patients still unproven
Insights
Windtree's announcement provides a timeline for istaroxime's interim analysis in more severe cardiogenic shock patients, building on previous positive studies.
Windtree Therapeutics has set July 2025 as the target for interim analysis results from their Phase 2 SEISMiC C Study of istaroxime in SCAI Stage C cardiogenic shock patients. This represents a strategic advancement in their clinical program, as the company has already completed two positive Phase 2 studies in less severe SCAI Stage B cardiogenic shock patients.
The SEISMiC C Study design is particularly notable for targeting more critically ill patients. It's a global, placebo-controlled, double-blinded trial evaluating istaroxime on top of current standard of care, including inotropes and vasopressors. The study will measure both immediate hemodynamic effects (with systolic blood pressure profile as the primary endpoint) and potential to reduce dependency on other vasopressors/inotropes.
This progression to SCAI Stage C patients is significant from a development perspective - success here would expand the potential patient population and provide evidence of efficacy in a more severely ill group with higher unmet medical need. The company frames this study as an important milestone toward initiating their Phase 3 program.
The interim analysis will include data from the first 20 patients, offering early insights into whether the hemodynamic benefits observed in Stage B patients translate to this more critical population. This stepwise approach of gradually testing in increasingly severe patient populations follows a logical clinical development strategy for critical care therapeutics. The comprehensive set of secondary endpoints will provide a well-rounded efficacy and safety profile in this higher-risk population.
Istaroxime has previously completed two positive Phase 2 studies in SCAI Stage B cardiogenic shock; the SEISMiC C study in SCAI Stage C cardiogenic shock is another step progressing to the istaroxime cardiogenic shock Phase 3 program
WARRINGTON, Pa., May 22, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue-generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, today announced it is targeting the planned interim analysis results for the istaroxime cardiogenic shock SEISMiC SCAI Stage C Phase 2 study (the “SEISMiC C Study”) for July 2025.
The SEISMiC C Study is a global trial including sites in the U.S., Europe and Latin America. It is a placebo-controlled, double-blinded study with istaroxime being added to current standard of care, including inotropes or vasopressors. The effect of istaroxime in addition to these therapies will be assessed for six hours followed by the ability for istaroxime to allow reduction in the other inotropes and vasopressors based on the patient’s condition. The primary endpoint of the study is the systolic blood pressure (“SBP”) profile over the first six hours of treatment. Other key study measurements include various measures of cardiac function, SBP changes at specified timepoints, the vasopressor-inotrope score, avoidance of progression to SCAI Stage D or E cardiogenic shock and need for mechanical cardiac support, time to treatment failure, arrhythmia assessments, days alive and out of the hospital through day 30, physiologic measures (e.g., cardiac index) and length of stay in the intensive care unit and hospital.
“The interim data from the SEISMiC C Study are very important as we continue to evaluate the profile of istaroxime in more seriously ill patients with cardiogenic shock due to heart failure. The data from the first 20 patients will provide an initial assessment of the ability of istaroxime to show the same kind of physiological impact on top of standard of care to what has been seen in the previous studies in SCAI Stage B cardiogenic shock, as well as the emerging safety profile in this population,” said Dr. Steve Simonson, Chief Medical Officer and Senior Vice President of Windtree Therapeutics. “Completion of the SEISMiC C Study is an important milestone to move steadily toward Phase 3 with istaroxime in cardiogenic shock.”
About Istaroxime
Istaroxime 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 can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue-generating company and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.
Forward Looking Statements
This press release contains statements related to the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. Such statements constitute 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, among other things: the Company could lose its deposit on the real estate property discussed above; the Company may fail to acquire such real estate property; the Company’s ability to acquire revenue generating subsidiaries; the market’s reaction to potential acquisitions by the Company; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; 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 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 the Middle East, 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:
Eric Curtis
ecurtis@windtreetx.com
FAQ
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