Stealth BioTherapeutics is looking for participants with primary mitochondrial myopathy (PMM) to participate in the MMPOWER-3 Phase 3 trial. This trial is designed to evaluate the efficacy and safety of daily subcutaneous injections of elamipretide, 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.
Participants will be randomized to receive either elamipretide or placebo for six months to determine whether treatment with elamipretide is associated with increased distance in the six-minute walk test and decreased patient-reported fatigue. Following the end of the six months, participants may elect to participate in the open-label treatment extension and will receive elamipretide for the remaining duration of the trial.
In order to participate in MMPOWER-3, individuals must:
- Have previous genetic testing results available
- Be able to walk
- Be between 16 years to 80 years of age
- Be diagnosed with PMM in the opinion of the investigator
- Be able to meet additional study criteria
To learn more or to inquire about participation, contact Cristy Balcells R.N., M.S.N., at Cristy.balcells@stealthbt.com or 423-914-8322.
To find out more information about the study, you may also visit https://clinicaltrials.gov/ct2/show/NCT03323749 or the Stealth BioTherapeutics website at www.stealthbt.com.