The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low blood pressure and signs of hypoperfusion (reduced oxygen to organs) which frequently require support with rescue therapies including inotropes, vasopressors, or mechanical devices.
Windtree Therapeutics, Inc. has been studying istaroxime, which has the potential to treat patients in this condition without some of the disadvantages of existing therapies being used to treat patients with acute heart failure and CS.
Participants enrolled in this trial will receive standard of care (SoC) therapy for heart failure and CS. Additionally, half of the participants will be randomly chosen to receive istaroxime. Istaroxime has the potential to increase blood pressure and improve cardiac function.

开始日期2024-06-01

申办/合作机构

Windtree Therapeutics, Inc.

NCT04325035

/ Completed临床2期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock (SEISMiC)

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

开始日期2020-09-28

申办/合作机构

Windtree Therapeutics, Inc.

[+1]

NCT02617446

/ Completed临床2期

The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure - A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study

To assess the safety, tolerability and efficacy of two different doses of istaroxime, a new agent with lusitropic and inotropic activities that improves the cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be infused via i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian patients with Acute Decompensated Heart Failure.

开始日期2015-12-01

申办/合作机构

Windtree Therapeutics, Inc.

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100 项与伊司他肟相关的转化医学

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项与伊司他肟相关的文献（医药）

2025-12-01·ESC Heart Failure

Haemodynamic Effects of Istaroxime in SCAI Stage B HF-Related Cardiogenic Shock: Insights from the SEISMiC Trial

Article

作者: Takagi, Koji ; Mebazaa, Alexander ; Pagnesi, Matteo ; Ponikowski, Piotr ; Filippatos, Gerasimos ; Zymliński, Robert ; Edwards, Christopher ; Diaz, Maria Luz ; Gulati, Gaurav ; Davison, Beth ; Novosadova, Maria ; Chioncel, Ovidiu ; Biegus, Jan ; Burkhoff, Daniel ; Guardia, Carlos ; Gajewski, Piotr ; Tycińska, Agnieszka ; Cotter, Gad ; Metra, Marco ; Simonson, Steven ; Simmons, Phillip ; Barros, Marianela

Abstract:

Aims:

The haemodynamic effects of istaroxime in SCAI stage B cardiogenic shock (CS) due to acute decompensated heart failure (ADHF) have not been evaluated. We assessed the impact of istaroxime on specific invasively-obtained haemodynamic measures.

Methods and results:

In the SEISMiC extension study, 30 patients with ADHF-related SCAI stage B CS were randomized to 60-h intravenous infusion of either placebo (n = 11) or istaroxime at maximum 0.5–1.0 μg/kg/min (n = 19). In this post hoc analysis, invasively-obtained haemodynamic measures, simulated group-averaged pressure-volume (PV) loops, and end-systolic elastance (Ees), derived from individual-patient PV relationships, were compared between istaroxime- and placebo-treated patients. Compared with placebo, patients randomized to istaroxime for 48–60 h had greater increases in aortic pulsatility index (API) and left ventricular (LV) stroke work index (LVSWI) at 6, 12, 24, and 48 h; and greater increase in pulmonary artery (PA) compliance and reduction in PA elastance at 48 h. At group-averaged PV loop analysis, LV contractility remained stable and right ventricular (RV) contractility tended to deteriorate over time with placebo, whereas LV contractility improved and RV contractility tended to be stabilized with istaroxime. Greater increases in both LV Ees and RV Ees were observed with istaroxime versus placebo from baseline to 48 h.

Conclusions:

In patients with ADHF-pre-CS, istaroxime at doses up to 1.0 μg/kg/min for up to 60 h was associated with sustained improvements in measures of LV performance (API and LVSWI), in parallel with increase in PA compliance and reduction in PA elastance at 48 h. As compared with placebo, istaroxime improved LV contractility and preserved RV contractility, which deteriorated on placebo, over time.

2025-09-23·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

How palytoxin transforms the Na ⁺ ,K ⁺ pump into a cation channel

Article

作者: Toyoshima, Chikashi ; Vilsen, Bente ; Cornelius, Flemming ; Tsunekawa, Naoki ; Kanai, Ryuta

Palytoxin (PTX), a potent marine toxin, has long been known to transform Na + ,K + -ATPase (NKA), an indispensable ion pump, into a nonselective cation channel. It has been postulated that PTX takes control of the two gates on either side of a channel-like pore. These gates normally open and close alternately, synchronized with chemical events, never opening simultaneously. A critical question is whether palytoxin takes over the control of the two gates or creates a new pathway. Here, we present structures of NKA with bound palytoxin in three different states. PTX binds to NKA in E2P, occupying the physiological Na + exit pathway, similar to istaroxime, a new-generation cardiotonic steroid. Adding Na + and ATP/ADP to the NKA·PTX complex induces an open channel traversing the entire membrane alongside the physiological ion pathway. As AlF x , a stable transition state analog of phosphate replaces phosphate in the NKA·PTX complex preformed in E2P, the complex appears to undergo the normal reaction cycle from E2P to E1· n Na + . PTX occupies the space between the transmembrane helices M4 and M6, thereby preventing the closure of the extracellular half of the ion pathway. These structures demonstrate that the architecture of NKA is fundamentally different from “a pore with two gates.” Each half of the ion pathway comprises three segments, including a movable component that plays a pivotal role in translocating the bound cations by connecting the constant part to an appropriate inlet. The ion pathway of NKA transforms dynamically, ensuring that the two halves never exist simultaneously.

2025-07-01·JOURNAL OF MOLECULAR AND CELLULAR CARDIOLOGY

Colitis induced ventricular alternans increases the risk for ventricular arrhythmia

Article

作者: Pereira, Carlos H ; Almeida, Jonathas F Q ; Keshavarzian, Ali ; Ouille V, Edward J ; Banach, Kathrin ; Kittaka, Hiroki ; Blatter, Lothar A ; Pélaez, Andrès F

Inflammatory bowel disease was linked to an increased risk for conduction defects and ventricular arrhythmia. It coincides with dysregulation of gut microbiota, increased inflammation, and deregulation of the renin-angiotensin system. In this study, we aimed to determine the mechanism of colitis-induced electrophysiological remodeling that increases the risk for ventricular arrhythmia. In a mouse model of dextran sulfate sodium induced active colitis (3.5 %, 7 days) cardiac electrophysiological properties were quantified during active inflammation. Electrocardiographic recordings exhibited a prolonged QT duration in mice with active colitis compared to control. Field potential (FP) recordings of Langendorff perfused colitis-hearts exhibited increased FP dispersion, a reduced threshold for ventricular alternans, and an increased propensity for spatially discordant alternans. The increased propensity for alternans was also reflected in isolated ventricular myocytes where Ca²⁺ transient alternans occurred at lower pacing frequencies and increased alternans ratios. The action potential was unchanged during colitis but myocytes exhibited a prolonged Ca²⁺ transient duration that corresponded with attenuated phospholamban phosphorylation. Stimulating cellular SERCA activity (Istaroxime), normalized the propensity for alternans. Serum levels of Angiotensin II (AngII) were increased during colitis and Angiotensin-converting enzyme (ACE) inhibitor or AngII receptor type 1 blocker prevented the increased alternans inducibility in isolated myocytes and hearts. Our data demonstrate that active colitis promotes reversible remodeling of ventricular Ca²⁺ handling properties and increases the propensity for alternans and arrythmia. The changes can be prevented by ACE or AT1R inhibition supporting a cardiac benefit for controlling RAS signaling in patients with active colitis.

106

项与伊司他肟相关的新闻（医药）

2025-09-04

·PRNewswire

Late Breaking Clinical Research Coming to Heart Failure Society of America Annual Scientific Meeting September 26-29

WASHINGTON, Sept. 4, 2025 /PRNewswire/ -- The Heart Failure Society of America (HFSA) is pleased to announce the Late Breaking Clinical Research that will be presented at its Annual Scientific Meeting (ASM), September 26-29, at the at the Minneapolis Convention Center in Minneapolis, MN. Late breaking clinical research to be featured during two plenary sessions includes results and updates from these major randomized trials: Continue Reading Heart Failure Society of America Annual Scientific Meeting 2025 takes place September 26-29 in Minneapolis, MN. Sunday, September 28 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 1: Devices and Cardiomyopathies Integra-D Trial Effects of a Novel Cardiac Contractility Modulation-Defibrillator (CCM-D) on NYHA Functional Class in ICD-Indicated Patients: Post-Implant Results from the Integra-D Trial FUTURE-HF Development of an Individualized Congestion Score using a Novel Implantable Inferior Vena Cava Sensor: the FUTURE-HF Trial Portfolio DETECT-HF Development and Training of a Voice-Based Algorithm for Heart Failure Monitoring: Performance results from 599 Patients over 360,000 Patient-Days FOREST-HCM Safety and Efficacy of Aficamten in Patients with Nonobstructive Hypertrophic Cardiomyopathy: a 96-week analysis from FOREST-HCM MAPLE-HCM Divergent Effect of Aficamten Versus Metoprolol on Exercise Performance in Obstructive Hypertrophic Cardiomyopathy: A Prespecified Analysis of MAPLE-HCM ATTRibute-CM Acoramidis Reduces Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Transthyretin Amyloid Cardiomyopathy: Results From ATTRibute-CM HELIOS-B Reduction in Gastrointestinal Events in ATTR-CM Patients Treated with Vutrisiran Compared with Placebo: Analysis from HELIOS-B Monday, September 29 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 2: Novel Therapies VICTOR Trial Vericiguat Efficacy and Safety Across Baseline Background Therapy in Contemporary Ambulatory Patients with HFrEF Enrolled in the VICTOR trial Tolerability and Safety of Vericiguat in Chronic Heart Failure with Reduced Ejection Fraction SEISMiC C Safety and Efficacy of Intravenous Administration of Istaroxime for 48 hours in Patients with SCAI C Cardiogenic Shock due to Acute Heart Failure SUMMIT Trial Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis from the SUMMIT Trial GARDEN TIMI-74 GDF-15 Neutralization in Patients with Heart Failure: Primary Results of the GARDEN-TIMI 74 Trial Danicamtiv Trial Danicamtiv Restores Ventricular and Atrial Function in Patients with Dilated Cardiomyopathy Caused by Genetic Variants that Depress Sarcomere Function Late Breaking Clinical Research showcases novel results of major randomized trials and rapidly evolving research. Due to the quantity of remarkable trials submitted, HFSA will also feature late breaking research through Rapid Fire Oral Sessions. These Rapid Fire sessions are fast-paced oral presentations spotlighting key data from late breaking clinical research. Sessions take place on Sunday and Monday with Q&A and new topics each day. Sunday September 28 | Rapid Fire 1 | 10:45 AM - 11:45 AM Phase 1 Study of Daratumumab-Hyaluronidase for Reduction of Circulating Antibodies in Patients with High Allosensitization Awaiting Heart Transplantation Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Post-Heart Transplant Patients: A Multi-Center Retrospective Cohort Study Long Term Outcomes after LVAD Weaning for Myocardial Recovery: Results from the VAD Wean Recovery Network First-In-Human Implantation of a Next-Generation Membrane-Based LVAD Long Term Trajectory of Glomerular Filtration Rate Post-LAVD and the Impact on Clinical Outcomes: An analysis of the MOMEMTUM 3 Study Increased LVEF at Six Months Following LVAD Implant is Associated with Improved Long-Term Outcomes - A MOMENTUM-3 Analysis Screening for advanced heart failure in stable outpatients (The SAINTS study) Sunday, September 28 | Rapid Fire 2: | 2:15 PM - 3:15 PM Clinical Outcomes for Heart Failure at High Risk of Hyperkalemia according to Optimization of Agents Targeting the Renin-Angiotensin-Aldosterone System Intravenous Ferric Carboxymaltose in Patients With Ischemic Versus Non-Ischemic Etiology of Heart Failure and Iron Deficiency Residual Risk of Hyperkalemia Among Patients with Heart Failure Treated with SGLT2i and ARNI Instead of ACEI/ARB High-Dose IV Loop Diuretic Therapy and Ototoxicity Risk in Patients with Acute Heart Failure: Insights from the FASTR Trial Expanded Results from a Guideline-Directed Medical Therapy Clinic Optimized Heart Failure Therapy in Patients at Risk of Cardiac Wasting in Patients with Advanced Cancer: Results from the EMPATICC trial Supervised Exercise Training Improves Outcomes in Heart Failure: Evidence from the PACT-HF 2×2 Factorial Trial Sunday, September 28 | Rapid Fire 3 | 4:15 PM - 5:15 PM Cardiac Contractility Modulation Reduces Mortality and Heart Failure Hospitalizations: A Matched Comparison of Patients Receiving and Not Receiving CCM Derived from a Real-World Dataset PROACTIVE-HF: 2-year outcomes, stratified by LVEF Outcomes of Poor Clinical Responders After Transcatheter Aortic Valve Replacement in Older Patients Invasive Hemodynamic Risk Stratification and Transcatheter Edge-to-Edge Tricuspid Repair: One-Year Results from TRILUMINATE Pivotal Trial Relationship between changes in seated pulmonary artery pressure, blood pressure, heart rate, and weight prior to heart failure hospitalization A Randomized Trial of a Remote, Digital Intervention Targeting Heart Failure Medical Therapy Machine-Learning Estimation of Pulmonary Capillary Wedge and Right Atrial Pressures With a Non-invasive Multisensor Device Deep learning assisted prediction for occurrence of pacing-induced cardiomyopathy in the atrio-ventricular block Monday, September 29 | Rapid Fire 4 | 12:00 PM – 1:00 PM Effect of vericiguat, compared with placebo, across baseline risk categories in chronic heart failure with reduced ejection fraction in the VICTOR Trial Effect of Vericiguat on Heart Failure Hospitalisation Events in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Effect of Vericiguat on Mortality in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Regional Variation in Outcomes and Response to Vericiguat in Heart Failure with Reduced Ejection Fraction: The VICTOR Trial Effect of the Soluble Guanylate Cyclase Stimulator Vericiguat on Health Status in the Phase 3 VICTOR Trial The Effect of Vericiguat on Mode of Death in Patients with Heart Failure with Reduced Ejection Fraction in the VICTOR Trial Rapidity of benefit of simultaneous initiation of finerenone and empagliflozin in people with chronic kidney disease and type 2 diabetes: the CONFIDENCE trial Dapagliflozin in Patients with Heart Failure: A Meta-Analysis of DAPA-HF, DELIVER, and DAPA ACT HF-TIMI 68 The meeting kicks off in just three weeks. A full schedule at a glance is available online, as well as information on the science and research and networking available at the meeting. Learn more about the meeting and register at hfsa.org/asm2025. About the Heart Failure Society of America The Heart Failure Society of America, Inc. (HFSA) represents the first organized effort by heart failure experts from the Americas to provide a forum for all those interested in heart function, heart failure, and congestive heart failure (CHF) research and patient care. The mission of HFSA is to provide a platform to improve and expand heart failure care through collaboration, education, innovation, research, and advocacy. HFSA members include physicians, scientists, nurses, nurse practitioners, pharmacists, trainees, other healthcare workers and patients. For more information, visit hfsa.org. Media Contact: Laura Poko, 301-798-4493, ext. 226, [email protected] SOURCE Heart Failure Society of America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期临床1期

2025-08-11

·GlobeNewswire-Health Care

Windtree Announces Istaroxime has been Chosen for a Plenary Session Presentation at the Heart Failure Society of America 2025

Presentation will be the interim data from the Phase 2 study of istaroxime in SEISMiC C - Cardiogenic Shock SCAI Stage C Cardiogenic shock SCAI Stage C has an in hospital mortality rate of 20-30% Istaroxime interim data was consistent with the profile seen in previous studies gives Windtree confidence to move forward with a global Phase 3 study WARRINGTON, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners, announced that istaroxime was chosen for a presentation entitled, “Safety and Efficacy of intravenous administration of istaroxime for 48 hours in patients with SCAI Stage C cardiogenic shock due to heart failure” at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025. Acute decompensated heart failure and cardiogenic shock have had very little drug innovation in decades. The Company believes istaroxime has a profile that offers potential benefits to patients with low blood pressure due to heart failure. Istaroxime improves cardiac function and can increase blood pressure without increasing heart rate. Also, istaroxime tends to preserve measures of renal function and contributes to resolution of congestion and fluid overload that often accompanies heart failure. Importantly, it does not appear to increase clinically significant arrythmias. The istaroxime cardiogenic shock SCAI Stage C interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies. “We are very pleased with the interim results of the SEISMiC C study,” said Jed Latkin, Chief Executive Officer of Windtree. “We believe istaroxime can be an important drug innovation for acute decompensated heart failure and cardiogenic shock patients because the istaroxime studies have promising results and this is a condition with a large unmet need and has been underserved for decades.” 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 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 diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners. Forward Looking StatementsThe 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 success of the SEISMiC C Study, the ability to move istaroxime to a global Phase 3 program and risks related to the Company’s ability to manage costs and execute on its operational and budget plans. 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 Curtisecurtis@windtreetx.com

临床2期临床3期AHA会议

2025-08-05

·GlobeNewswire-Health Care

Windtree Announces Istaroxime Phase 2 Interim Analysis in SCAI Stage C Cardiogenic Shock Patients

Istaroxime was added to currently available inotropes and vasopressors in the study - no new safety signals were identified and physiological improvements were consistent with istaroxime responses in previous trials Cardiogenic shock is a severe presentation of heart failure and SCAI Stage C patients have low blood pressure and signs of organ damage due to low blood flow These data provide the Company confidence to move forward with a global Phase 3 trial WARRINGTON, Pa., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners, has performed a planned interim analysis of the SEISMiC C Phase 2 study data evaluating istaroxime in SCAI Stage C cardiogenic shock which showed istaroxime had a similar profile to that seen in previous studies despite a greater severity of illness and being used in addition to currently available inotropes and vasopressors. The SEISMiC C Study is a global trial including sites in the U.S., Europe and Latin America. It is placebo-controlled, double-blinded study with istaroxime being added to current standard of care, including inotropes or vasopressors in patients with more severe cardiogenic shock (SCAI stage C) than has been studied previously. The study follows the results of the SEISMIC B study where istaroxime was shown to improve blood pressure and hemodynamic variables such as cardiac output (the amount of blood pumped by the heart per minute), reduced filling pressures in the heart and improved signs of organ perfusion such as mixed venous oxygenation in patients with milder cardiogenic shock (SCAI stage B). This data is contributing to a very unique profile of istaroxime in acute decompensated heart failure across severity of illness. Inotropes and vasopressors agents are given to many patients in intensive care units in the USA every year and the results of the SEISMIC program may suggest potential advantages to istaroxime over existing therapies in efficacy and possibly safety. The SESIMIC C study was designed to assess the effects of istaroxime in patients with SCAI Stage C cardiogenic shock (i.e., more severe cardiogenic shock than patients enrolled in previous acute heart failure and cardiogenic shock studies in the past). Many patients in SESIMIC C were treated at the time of enrollment with vasopressors or inotropes and hence the SESIMIC C study is testing for the first time the safety and efficacy of istaroxime in more severe cardiogenic shock when istaroxime treatment is combined with other therapies for cardiogenic shock. The interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrhythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies. “The results of the SEISMIC C interim analysis are exciting,” said Jed Latkin, Chief Executive Officer of Windtree. “We believe these data will be instrumental in moving istaroxime to a global Phase 3 program in heart failure and cardiogenic shock. Steve Simonson, Chief Medical Officer added, “The interim data are consistent with the previous clinical study results seen in patients with AHF and less severe forms of cardiogenic shock. These data are encouraging for the potential of istaroxime to be effective across the spectrum of cardiogenic shock due to AHF with or without other inotropic or vasopressor drugs.” 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 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 diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners. Forward Looking StatementsThe 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 success of the SEISMiC C Study, the ability to move istaroxime to a global Phase 3 program and risks related to the Company’s ability to manage costs and execute on its operational and budget plans. 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 Curtisecurtis@windtreetx.com

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适应症	最高研发状态	国家/地区	公司	日期
低血压	临床2期	罗马尼亚	Windtree Therapeutics, Inc.	2021-05-27
休克	临床2期	美国	Windtree Therapeutics, Inc.	2020-09-28
休克	临床2期	阿根廷	Windtree Therapeutics, Inc.	2020-09-28
休克	临床2期	意大利	Windtree Therapeutics, Inc.	2020-09-28
休克	临床2期	波兰	Windtree Therapeutics, Inc.	2020-09-28
心源性休克	临床2期	美国	Windtree Therapeutics, Inc.	2020-09-28
心源性休克	临床2期	阿根廷	Windtree Therapeutics, Inc.	2020-09-28
心源性休克	临床2期	意大利	Windtree Therapeutics, Inc.	2020-09-28
心源性休克	临床2期	波兰	Windtree Therapeutics, Inc.	2020-09-28
急性失代偿性心力衰竭	临床2期	法国	-	2008-09-25

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04325035 (SEISMiC, GlobeNewswire) 人工标引	临床2期	心源性休克	20	Istaroxime	艱鹹艱顧鹽鏇淵簾鏇醖(選鹽觸夢願製餘獵醖積) = There were no new safety concerns identified, and no apparent excess arrhythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies. 壓襯廠願願襯鑰壓膚觸 (廠醖網夢夢廠觸襯夢鬱 )	积极	2025-08-05
				Placebo
NCT04325035 (SEISMiC, GlobeNewswire) 人工标引	临床2期	心脏衰竭	30	Istaroxime	壓壓餘廠齋餘糧繭艱鹹(齋襯窪築齋襯襯製鹽齋) = 壓簾積鏇遞選壓鬱醖遞顧壓構鹽膚顧衊構鹽觸 (築齋鑰夢願觸憲齋鑰遞 ) 更多	积极	2024-09-30
				Placebo	壓壓餘廠齋餘糧繭艱鹹(齋襯窪築齋襯襯製鹽齋) = 鏇衊積膚膚鏇鬱鏇觸願顧壓構鹽膚顧衊構鹽觸 (築齋鑰夢願觸憲齋鑰遞 ) 更多
NCT02617446 (CTgov)	临床2期	急性失代偿性心力衰竭	120	Istaroxime (Istaroxime 0.5 µg/kg/Min)	膚願鹹廠鹹齋製構憲壓(顧積膚鬱鹹願憲壓鏇淵) = 鹽選鬱鏇觸遞蓋構淵製廠選餘構醖齋積製餘窪 (廠築壓憲廠製構鬱積範, 鹹襯築淵範襯窪獵夢獵 ~ 獵願範艱艱齋構餘鏇淵) 更多	-	2023-05-24
				Istaroxime (Istaroxime 1.0 µg/kg/Min)	膚願鹹廠鹹齋製構憲壓(顧積膚鬱鹹願憲壓鏇淵) = 齋廠鏇範蓋窪餘鏇鏇鑰廠選餘構醖齋積製餘窪 (廠築壓憲廠製構鬱積範, 築鹽願願醖糧簾築鹹顧 ~ 製蓋齋築艱繭糧廠鹽築) 更多
NCT02772068 (Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a, Pubmed \| JACC Heart Fail)	早期临床1期	射血分数保留型心力衰竭	26	Istaroxime 0.5 mg/kg/min	齋觸憲淵糧壓淵簾繭獵(壓齋觸鬱壓鹽鹹鬱觸繭) = 鹽艱顧製襯築餘顧憲築鏇獵鏇積選鹹鹽窪範蓋 (淵鹹構鬱淵餘繭構製艱 ) 更多	-	2023-03-15
				Placebo	齋觸憲淵糧壓淵簾繭獵(壓齋觸鬱壓鹽鹹鬱觸繭) = 觸繭顧衊遞醖觸鏇選衊鏇獵鏇積選鹹鹽窪範蓋 (淵鹹構鬱淵餘繭構製艱 ) 更多
SEISMiC (Pubmed \| Eur J Heart Fail)	临床2期	-	-	Istaroxime 1.0-1.5 μg/kg/min	觸鏇醖襯鹹鬱蓋衊衊製(繭齋艱選鏇網糧顧範鹹) = 遞構鏇鏇網遞壓艱鏇築繭鹹鹹選壓夢窪繭蓋蓋 (淵範構築夢遞網淵鑰顧, 6.88) 更多	积极	2022-10-01
				Placebo	觸鏇醖襯鹹鬱蓋衊衊製(繭齋艱選鏇網糧顧範鹹) = 膚鹽廠鏇製鏇窪壓鏇廠繭鹹鹹選壓夢窪繭蓋蓋 (淵範構築夢遞網淵鑰顧, 6.76)
NCT04325035 (SEISMiC, Pubmed) 人工标引	临床2期	心脏衰竭 \| 休克	60	istaroxime	壓願簾艱襯壓繭鏇選築(簾鬱衊艱遞廠鑰艱蓋鹽) = 鹹膚構築夢遞齋鑰膚鑰鹹獵醖鑰夢齋夢鹽窪糧 (鏇憲廠網醖選選觸鑰簾, 6.88) 更多	积极	2022-07-22
				Placebo	壓願簾艱襯壓繭鏇選築(簾鬱衊艱遞廠鑰艱蓋鹽) = 遞鑰襯鹹製艱壓獵壓築鹹獵醖鑰夢齋夢鹽窪糧 (鏇憲廠網醖選選觸鑰簾, 6.76) 更多
NCT04325035 (SEISMiC, Biospace) 人工标引	临床2期	心脏衰竭 \| 心源性休克	60	Istaroxime	製獵繭齋願餘鬱憲醖鹽(製廠壓壓鏇範鏇願簾鹹): P-Value = 0.017 更多	积极	2022-05-23
				Placebo
NCT00616161 (HORIZON-HF, Pubmed \| J Am Coll Cardiol)	临床2期	心脏衰竭	120	Istaroxime	餘顧構選膚繭廠鑰遞夢(選餘觸製繭憲窪遞餘衊) = 齋襯壓觸膚壓餘鏇積製壓網憲鹽築蓋製憲選糧 (壓窪簾艱憲鑰鹽糧蓋膚 )	-	2008-06-10