Windtree Publishes Positive Istaroxime Phase 2b Study Design

Windtree Therapeutics, Inc., a biotechnology company listed on NasdaqCM under the symbol WINT, has recently announced positive topline results from the Phase 2b study involving istaroxime in patients with acute heart failure and early cardiogenic shock. The trial design of this study, known as the SEISMiC Phase 2b, has been published by the European Society of Cardiology Heart Failure in an article titled "Safety and efficacy of up to 60 hours of intravenous istaroxime in pre-cardiogenic shock patients: Design of the SEISMiC trial." This article is accessible online in the Wiley Online Library.

Cardiogenic shock is a severe condition characterized by high mortality and morbidity, posing significant treatment challenges for physicians. Traditional drug therapies for this condition often result in suboptimal outcomes and considerable side effects. Istaroxime, a novel investigational therapy, aims to address these issues by enhancing both systolic contraction and diastolic relaxation of the heart, increasing blood pressure, and maintaining renal function, all with a generally favorable safety profile. This drug has been studied in four positive Phase 2 trials involving patients suffering from acute heart failure and early cardiogenic shock due to heart failure.

Dr. Steve Simonson, Chief Medical Officer and Senior Vice President at Windtree, highlighted that the published article provides a detailed review and explanation of the Phase 2b trial, including its design, assessments, procedures, outcome measures, and endpoints. He emphasized that this clinical study approach has been the foundation for the ongoing SEISMiC C study, which tests istaroxime in more severe SCAI Stage C cardiogenic shock patients. Dr. Simonson expressed satisfaction with the progress of the program toward Phase 3 readiness in treating cardiogenic shock.

Istaroxime is described as a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac functions. It functions as a positive inotropic agent that enhances myocardial contractility by inhibiting Na+/K+-ATPase and also promotes myocardial relaxation by activating the SERCA2a calcium pump on the sarcoplasmic reticulum, thereby enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies have shown that intravenous infusion of istaroxime significantly improves cardiac function and blood pressure without increasing heart rate or causing cardiac rhythm disturbances.

Windtree Therapeutics, Inc. focuses on developing innovative therapies for critical conditions and diseases, spanning both early and late-stage development. Their portfolio includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, as well as preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors for potential use in rare and broad oncology applications. Additionally, Windtree follows a licensing business model with current partnership out-licenses.

Windtree's efforts in advancing the clinical development of istaroxime reflect their commitment to addressing the significant unmet medical needs in acute heart failure and cardiogenic shock. The company continues to focus on bringing innovative solutions to critical healthcare challenges, aiming to improve patient outcomes and quality of life.