26th of October 2018

Stealth Biotherapeutics is a pharmaceutical company focussing on the development of drugs against mitochondrial diseases and many common age-related diseases. The company is currently conducting a phase III clinical trial called MMPOWER-3. It concerns a randomized trial to evaluate the efficacy and safety of elamipretide in patients with Primary Mitochondrial Myopathy. This is followed by an open-label treatment extension with elamipretide.

Once a drug has proved satisfactory after phase III trials, the regulatory authorities (FDA and EMA) will review everything and, it is hoped, give approval to market the drug so that it becomes available for patients. In Europe, after EMA’s approval, each individual country carries out its own review and then decides on approval for the national market.

The drug elamipretide will be administered through daily subcutaneous (under the skin) injections. Elamipretide is an investigational drug that associates with cardiolipin, a key structural component of the inner mitochondrial membrane, and has shown to improve mitochondrial function in preclinical and early clinical studies. 

The trial will assess approximately 200 patients, aged 16-80, across North America and Europe.

Visit  https://www.clinicaltrials.gov/ for a list of trial sites.

Patients that have a genetic confirmation of mitochondrial disease are potentially eligible for participation in MMPOWER-3.

The clinical trial investigator will identify potential patients.

At this time Stealth is providing access to elamipretide only through clinical trials.

For more information:

Website: https://www.stealthbt.com/ or https://mitotrials.com/

Protocol (pdf): MMPOWER-3 protocol for patient advocacy groups

For contact:

Twitter: @stealthbt

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.