Approximately 600 patients expected to be enrolled at clinical sites across the United States, Europe, China and South America

Global Phase 3 program, RESCUE HF-CS, builds upon three completed Phase 2 programs in which more than 350 patients enrolled

Seismic Pharmaceuticals, a biotechnology company dedicated to advancing novel treatments for heart failure, announced the enrollment of the first patient in its global Phase 3 clinical trial evaluating istaroxime in patients with heart-failure-related cardiogenic shock. The trial, called RESCUE HF-CS, will recruit patients from around the globe and is designed to become the first ever drug approved to treat the life-threatening condition of cardiogenic shock. 

The approximately 600-patient study will be conducted at clinical sites across the United States, Europe, China and South America. The trial is designed to build upon the successful clinical results generated through four previously completed Phase 2 trials.  

Cardiogenic shock is a life-threatening condition that occurs when the heart is unable to pump enough blood to meet the body's needs, resulting in inadequate blood flow and oxygen delivery to vital organs. It may occur as a complication of acute heart failure or other serious cardiac conditions. Despite advances in critical care, cardiogenic shock continues to be associated with high rates of complications and mortality, underscoring the urgent need for new therapeutic options. There are no currently FDA-approved medications for the condition. 

Istaroxime is a novel, first-in-class calcitrope being developed to improve cardiac function and hemodynamic stability in patients with cardiogenic shock. 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.

"Cardiogenic shock remains one of the most lethal conditions we encounter in cardiovascular medicine, yet remarkably, we still lack an approved pharmacologic therapy specifically developed for this syndrome," said the study principal investigator Dr. Mandeep R. Mehra, MBBS, MSc, FRCP, The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine, Mass General Brigham Heart & Vascular Institute, Professor of Medicine, Harvard Medical School. He added: "The launch of RESCUE HF-CS represents an important opportunity to determine whether istaroxime, with its distinctive ability to enhance cardiac performance while supporting diastolic relaxation, can meaningfully change the treatment paradigm for these critically ill patients."

The Phase 3 trial, RESCUE HF-CS, is expected to enroll approximately 600 patients with cardiogenic shock. Additional information regarding the trial's design, eligibility criteria and participating clinical sites will be available at ClinicalTrials.gov and other applicable clinical-trial registries.