Windtree Therapeutics starts patient dosing in Phase 2 SEISMiC extension study

Windtree Therapeutics 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 due to acute heart failure 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,” Windtree stated.