Windtree Updates on Istaroxime Clinical Progress

Windtree Therapeutics, a biotechnology company focused on early and late-stage innovative therapies for critical conditions and diseases, has announced an update of istaroxime in clinical and business development. Istaroxime is a novel first-in-class therapy designed to improve systolic contraction and diastolic relaxation of the heart while increasing blood pressure and maintaining or improving renal function. 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. The extension study will focus on dose optimization and additional characterization of SERCA2a effects for Phase 3 planning and is expected to enroll up to 30 patients. The study will evaluate two-dose regimens of istaroxime compared to placebo, with patients receiving infusions of istaroxime for up to 60 hours. The company believes extending the dosing duration of istaroxime has the potential to provide additional benefit and is an important factor in determining the optimal dosing regimen to study in late-stage trials.

The company is also progressing the start-up of a parallel study in more severe, SCAI Stage C cardiogenic shock patients. The study will be a placebo controlled, double-blinded study with istaroxime being added to current standard of care using inotropes or vasopressors. The execution of this study will depend on the Company's ability to obtain adequate resources for its completion. In January 2024, Windtree entered into a license agreement with Lee's Pharmaceutical (HK) Limited for the development and commercialization of istaroxime in Greater China, including for acute heart failure and cardiogenic shock.