Source: Stealth BioTherapeutics & reported by http://www.prnewswire.com/
BOSTON, Sept. 12, 2016 /PRNewswire/ -- Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of a longitudinal extension trial for evaluating elamipretide in primary mitochondrial disease. The study, MMPOWER-2, will be limited to patients who completed the initial MMPOWER Phase 2 study. Positive data from MMPOWER were announced in June 2016 showing statistically significant improvement in distance walked in six minutes.
"Patients with rare primary mitochondrial diseases have no FDA-approved treatment options to address their needs," said Stealth Chief Executive Officer Reenie McCarthy. "We're committed to helping fill these significant gaps in care through our study of elamipretide. Following the promising results from our Phase 2 MMPOWER study, we're happy to announce the initiation of MMPOWER-2, which will help us better understand the effects of longer treatment with elamipretide for these patients, who often face severe challenges completing even simple daily activities."
MMPOWER-2 is a randomized, double-blind, placebo-controlled crossover study to evaluate the safety, tolerability and efficacy of four weeks' treatment with once-daily subcutaneous injections of elamipretide in patients with genetically confirmed mitochondrial disease. All patients in this study have previously completed the MMPOWER study.
Read more: http://www.prnewswire.com/news-releases/stealth-biotherapeutics-initiates-phase-2-study-of-elamipretide-in-primary-mitochondrial-disease-300325810.html