US-based biopharmaceutical company Stealth BioTherapeutics has commenced two Phase II trials of investigational drug elamipretide to treat heart failure patients.
The trials include PROGRESS-HF in patients with heart failure with reduced ejection fraction and RESTORE-HF in those with preserved ejection fraction.
Top-line report of both phases is expected at the second half of next year.
Both the randomised, double-blind, placebo-controlled trials are designed to measure the effects of elamipretide on left ventricular function in patients with stable heart failure with reduced ejection fraction (PROGRESS-HF) or preserved ejection fraction (RESTORE-HF).
Elamipretide will be administered through subcutaneous injections on a daily basis over a duration of four weeks.
PROGRESS-HF primarily focuses on changing from baseline in the volume of blood remaining in the left ventricle at the end of contraction, as measured by the cardiac MRI.
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The secondary endpoint of PROGRESS-HF involves other measures of cardiac function, including ejection fraction, by echocardiography and MRI.
The primary endpoints of RESTORE-HF focus on changes in diastolic heart function while resting and when subjected to submaximal stress, as measured by echocardiography.
The secondary endpoint of RESTORE-HF involves changes in exercise capacity determined after a six-minute walk test, and responses to the SF36 patient-reported health survey.
Stealth clinical development vice-president Jim Carr said: "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.
"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."
Stealth’s elamipretide has been developed to modify disease by preserving energetics and reviving normal energy production in mitochondria, while minimising oxidative stress.