Seismic Pharmaceuticals, a biotechnology company focused on advancing novel treatments for heart failure, announced on Wednesday the enrolment of the first patient in its global Phase 3 clinical trial evaluating istaroxime in patients with heart-failure-related cardiogenic shock.
The RESCUE HF-CS trial aims to recruit approximately 600 patients at clinical sites across the United States, Europe, China and South America, with istaroxime potentially becoming the first ever drug approved to treat the life-threatening condition of cardiogenic shock.
It follows the successful clinical results generated through four previously completed Phase 2 trials.
Istaroxime is a novel, first-in-class calcitrope being developed to improve cardiac function and haemodynamic stability in patients with cardiogenic shock. The company says that unlike conventional inotropic therapies, istaroxime has a unique dual mechanism of action designed to improve both systolic contraction and diastolic relaxation. Contrary to other therapies used off-label to treat cardiogenic shock, istaroxime does not increase myocardial oxygen demand, and it reduces heart rate and arrythmias.
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