Windtree Therapeutics Inc (WINT)

[Mr. Zen]

Windtree Therapeutics Announces the Start of Patient Dosing In Phase 2 SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock

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 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 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.