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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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).

"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."

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.