WARRINGTON, PA — Windtree Therapeutics, Inc., a Pennsylvania-based biotech firm, this week launched a Phase 2 extension study of istaroxime, a novel therapy designed for early cardiogenic shock treatment, marking a significant step forward in the company’s pursuit of new heart failure solutions. The announcement comes as the company enrolls its first subject in the study, with results projected for mid-2024.
The extension study builds on the positive outcomes of the SEISMiC study, aiming to enroll up to 30 subjects to test a longer dosing cycle of istaroxime. This innovative therapy is engineered to enhance both the contraction and relaxation phases of a heartbeat, while simultaneously boosting blood pressure – a promising development for patients hospitalized with early cardiogenic shock due to acute heart failure (AHF).
The study will compare two dosage regimens of istaroxime against a placebo, with one group receiving a gradually decreasing dosage over time, and the other a consistent, lower dose. The infusion period for istaroxime will extend up to 60 hours, a significant increase from the previous 24-hour infusion period in the initial SEISMiC study. Windtree Therapeutics believes this extended dosing duration could potentially offer additional benefits to patients and play a crucial role in determining the optimal dosing regimen for a potential Phase 3 trial.
In parallel with the SEISMiC Extension Study, Windtree is preparing to launch another study focusing on patients suffering from more severe cardiogenic shock, known as SCAI Stage C. These patients typically experience low blood pressure and insufficient blood flow to vital organs. The istaroxime cardiogenic shock SCAI Stage C study aims to enroll up to 20 subjects, with data expected to be available in a similar timeframe as the SEISMiC Extension Study.
Craig Fraser, Windtree’s President and CEO, stated, “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.” He added that the results from both studies will play a crucial role in finalizing the company’s strategy and design for Phase 3 clinical trials and their end of Phase 2 discussions with the FDA.
Investors will likely monitor these developments closely, as positive results could solidify Windtree Therapeutics’ position in the market for heart failure treatments and potentially offer a new lifeline for patients suffering from cardiogenic shock.
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