Windtree's Latest Advances: Istaroxime Clinical Trials

Windtree Therapeutics Updates Istaroxime Clinical Development and Trial Data

Providing a thorough update on the clinical and business development of istaroxime, Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company committed to developing creative therapies for critical diseases, has This first-in-class treatment seeks to raise blood pressure, preserve or increase renal function, and strengthen systolic contraction and diastolic relaxation of the heart. In three Phase 2 trials, including patients with acute heart failure (AHF) and early cardiogenic shock, Istaroxime has shown encouraging outcomes.

Progress in Phase 2 SEISMiC Extension Study

For its Phase 2 SEISMiC Extension Study in SCAI Stage B early cardiogenic shock patients, Windtree expects to finish enrollment in a few weeks. By the end of this quarter, topline data for this study are expected. Building on the encouraging findings of the earlier SEISMiC study, this one focuses on dose optimization and additional SERCA2a effect characterization in preparation for Phase 3 trials. Up to thirty patients will take part; the study compares two dosing schedules of istaroxime against a placebo over sixty hours. One group will get a constant dose, while the other will have a declining istaroxime dose over time.

Unlike the previous SEISMiC study, which limited treatment to 24 hours, this study seeks to increase the dosing duration. Extending the dosing period and changing the dose titration, according to Windtree, might offer extra advantages. This work will also gather comprehensive data on heart function, especially with reference to the SERCA2a mechanism of action. Especially, istaroxime has not been connected to a rise in cardiac arrhythmias, a major distinguishing feature from vasopressors and currently used inotropes.

Upcoming Parallel Study for SCAI Stage C Patients

Windtree is also moving forward with the start-up of a parallel study for patients with SCAI Stage C cardiogenic shock, a more severely ill population than those investigated in the SEISMiC study. The SEISMiC C study will examine data following the enrollment of up to 20 patients with SCAI Stage C cardiogenic shock resulting from acute decompensated heart failure. This double-blind, placebo-controlled trial will evaluate the inclusion of istaroxime into conventional treatment regimens, including vasopressors or inotropes.

Over the first six hours of treatment, this study's main endpoint is the evaluation of the systolic blood pressure (SBP) area under the curve. Other important measurements include SBP changes at designated times, the vasopressor-inotrope score, progression to SCAI Stage D or E cardiogenic shock, time to treatment failure, arrhythmia assessments, days alive and out of the hospital through day 30, physiological measurements such as cardiac index, and length of stay in the ICU and hospital. The way this study is carried out will depend on Windtree's capacity to obtain sufficient means for completion.

License Agreement with Lee’s Pharmaceutical

Windtree revealed in January 2024 a license agreement for the development and commercialization of istaroxime in Greater China with Lee's Pharmaceutical (HK) Limited. This agreement comprises preclinical next-generation dual mechanism SERCA2a activators and rostafuroxin, a Phase 2 candidate for hypertension linked with particular genotypes, as well as istaroxime for AHF and cardiogenic shock. Along with low double-digit royalties and complete coverage for all development, manufacturing, regulatory, and commercialization costs in the licensed territory, the agreement provides possible future milestones up to $138 million. Later this year, Windtree intends to present a development update on Lee's program.

CEO Statement

The CEO and Chairman of Windtree Therapeutics, Craig Fraser, expressed pleasure with the advancement in clinical research and the cooperation with Lee's Pharmaceutical. "We are happy with our progress in clinical development because of the great unmet needs in the patient populations we are studying," Fraser said. "Moreover, we are happy to have a licensing partner in Lee's who can enable us to advance our acute heart failure program using their resources. With further resources, we hope to keep moving forward with the SCAI Stage C study and get ready for Phase 3. Later this quarter, we will report the topline extension study results.

About Istaroxime

Designed to increase systolic and diastolic cardiac function, first-in-class dual-mechanism therapy Istaroxime is Being a positive inotropic agent, it reduces Na+/K+-ATPase's activity to boost myocardial contraction. By activating the SERCA2a calcium pump on the sarcoplasmic reticulum, it improves calcium reuptake from the cytoplasmic reticulum and promotes myocardial relaxation. Data from several Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure show that istaroxime, injected intravenously, greatly increases cardiac function and blood pressure without raising heart rate or the incidence of cardiac rhythm disturbances.

About Windtree Therapeutics, Inc.

Focused on advancing early and late-stage innovative treatments for critical conditions and diseases, Windtree Therapeutics, Inc. is a biotechnology company. Among Windtree's portfolio are preclinical SERCA2a activators for heart failure and istaroxime, a Phase II candidate with SERCA2a activating qualities for acute heart failure and related cardiogenic shock. Preclinical precision aPKCi inhibitors for possible use in rare and general oncology applications are another project the company is working on. With current partnership out-licenses, Windtree runs a licensing business model that allows it to use outside resources and knowledge to progress its creative ideas.

Developing and commercializing creative therapies to meet unmet medical needs in critical care and cardiovascular health remains a top priority for Windtree Therapeutics. Through strategic alliances and continuous clinical trials, the company seeks to provide patients all around the world the world with efficient treatments.

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