Windtree Therapeutics, Inc, a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, announced an update of istaroxime in both clinical and business development. Istaroxime is a novel first-in-class therapy that is designed to improve systolic contraction and diastolic relaxation of the heart while also increasing blood pressure and maintaining or improving renal function. It has been studied in three positive Phase 2 trials enrolling patients with acute heart failure (AHF) and early cardiogenic shock.
In line with previous guidance, the Company expects its Phase 2 SEISMiC Extension Study in SCAI Stage B early cardiogenic shock patients to complete enrollment in the next several weeks and report topline data by the end of this quarter. Building upon the positive SEISMiC study results, the Extension Study is focused on dose optimization and additional characterization of SERCA2a effects for Phase 3 planning and is expected to enroll up to 30 patients. The study of hospitalized patients with early cardiogenic shock (SCAI Stage B) due to AHF evaluates two-dose regimens of istaroxime compared to placebo. Patients will receive infusions of istaroxime for up to 60 hours, with one group receiving a decreasing istaroxime dose over time and the second group receiving a consistent istaroxime dose. This study will extend the dosing duration compared to the previous positive SEISMiC study, in which study treatment was limited to 24 hours.
The Company believes 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 late-stage trials. The study is also collecting detailed information related to heart function, particularly associated with the SERCA2a mechanism of action. Istaroxime has not been associated with an increase in cardiac arrhythmias, which the Company believes is a potentially important differentiating characteristic compared to currently used inotropes and vasopressors.
Further, the Extension Study is measuring the effects of istaroxime on blood pressure and cardiac function with the two dosing regimens similar to the improvements seen in the previous SEISMiC study.
The Company is also progressing the start-up of a parallel study in more severe, SCAI Stage C cardiogenic shock patients. SCAI stage C is a more severely ill population than was previously studied in the SEISMiC study. SEISMiC C data will be reviewed after enrollment of up to 20 patients with SCAI Stage C cardiogenic shock due to acute decompensated heart failure. It will be a placebo controlled, double-blinded study with istaroxime being added to current standard of care using inotropes or vasopressors. The effect of istaroxime in addition to these therapies will be assessed for 6 hours followed by withdrawal of the standard of care therapies. The primary endpoint is assessment of systolic blood pressure (SBP) area under the curve over the first 6 hours of treatment.
SOURCE: GlobeNewswire