Stealth BioTherapeutics Initiates Two Phase 2 Trials Evaluating Elamipretide for the Treatment of Heart Failure


BOSTON, 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).  

The primary endpoint of PROGRESS-HF is change from baseline in the volume of blood remaining in the left ventricle at end of contraction, as assessed by cardiac magnetic resonance imaging (MRI). Secondary endpoints will include additional measures of cardiac function, including ejection fraction, by echocardiography and MRI. The primary endpoints of RESTORE-HF are changes in diastolic heart function at rest and during submaximal stress, as assessed by echocardiography. Secondary endpoints include changes in exercise capacity, as measured by the six-minute walk test, and responses to the SF36 patient-reported health survey.

"Our initiation of these Phase 2 trials marks an important milestone for Stealth and the progression of our cardiorenal program for elamipretide. Following the promising findings from our Phase 1 PREVIEW trial in heart failure, we hope to demonstrate improvements in heart function across both types of heart failure with longer-term dosing," said Stealth Chief Executive OfficerReenie McCarthy.

Source: Stealth BioTherapeutics 

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