BOSTON, June 27, 2016 /PRNewswire/ -- Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of two Phase 2 studies evaluating elamipretide in heart failure: PROGRESS-HF in patients with heart failure with reduced ejection fraction and RESTORE-HF in those with preserved ejection fraction. Top-line data from each are expected in the second half of 2017.
"The heart's reduced ability to relax and contract during heart failure may be linked to mitochondrial dysfunction and a resulting lack of energy in heart muscle," said Stealth Vice President of Clinical Development Jim Carr. "Since muscle is required for both pumping and re-filling the heart, we believe elamipretide could address this lack of energy in the heart muscle in the two major forms of heart failure by improving mitochondrial function."
PROGRESS-HF and RESTORE-HF are randomized, double-blind, placebo-controlled trials to evaluate the effects of four weeks' treatment with daily subcutaneous injections of elamipretide on left ventricular function in patients with stable heart failure with reduced ejection fraction (PROGRESS-HF) or preserved ejection fraction (RESTORE-HF).
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