Stealth BioTherapeutics has initiated IDDEA-HF, a Phase 2 study evaluating elamipretide in patients hospitalised due to congestive heart failure.

Heart failure causes more than two million hospitalisations in the US and Europe every year.

Stealth vice president of clinical development Jim Carr said: “In heart failure, mitochondrial dysfunction may not only be a causative factor, but may also contribute to the progression of the disease and the associated fluid build-up that causes congestion, due to muscle weakness from a lack of energy production.

“In line with our findings in elderly patients enrolled in the trial, we hope to demonstrate the ability of elamipretide to increase energy production to help the heart muscle work better, subsequently relieving congestion in the body.”

"IDDEA-HF is a key step in our development of therapies for common diseases of aging."

IDDEA-HF is a randomised, double-blind, placebo-controlled study to analyse the cardiac and renal effects of daily treatment with elamipretide in patients who have been hospitalised with congestive heart failure.

Up to 300 patients will be randomised within 72 hours of presentation to receive 20mg daily elamipretide or placebo intravenously for up to seven days.

The primary endpoint is a change in NT-proBNP, a cardiac biomarker reflecting the level of congestion, while secondary endpoints include changes in clinical status and safety and tolerability.

Stealth CEO Reenie McCarthy said: “IDDEA-HF is a key step in our development of therapies for common diseases of aging.

"These patients have failed current therapies, experiencing an episode of acute decompensation, which highlights the intense need for new options within the heart failure treatment paradigm where we believe elamipretide can have a significant impact.

“The data from this study, together with our other ongoing trials in heart failure, will help inform our projected Phase 3 heart failure programme, as well as our approach to other common diseases of aging, for which elamipretide may have therapeutic potential."