Windtree Therapeutics (NASDAQCM:WINT) dosed the first patient in its Phase 2 study evaluating istaroxime in patients with early cardiogenic shock due to heart failure.
Cardiogenic shock is a condition where the heart cannot provide adequate blood flow to vital organs and is associated with a high risk of mortality. Istaroxime is a dual mechanism therapy designed to improve both systolic and diastolic cardiac function.
This study will enroll 60 patients who will receive either istaroxime or placebo infusion over 24 hours. The trial’s primary endpoint is the change in systolic blood pressure over six hours after initiating the infusion. Secondary endpoints include renal function, blood pressure changes over 24 hours and the number of patients requiring rescue therapy.
“We believe istaroxime’s dual mechanism of action, improving both systolic contraction of the heart as well as diastolic function, along with positive effects on blood pressure, could be a key approach in effectively bringing severe acute heart failure patients out of this critical condition,” Craig Fraser, Windtree’s CEO, said in a statement.
The company also is developing istaroxime for the treatment of acute heart failure, which is supported by positive Phase 2a and Phase 2b trial results and an FDA fast track designation.