Phase III MMPOWER-3 trial of Ocuvia fails to meet endpoint in primary mitochondrial myopathy.- Stealth BioTherapeutics

Stealth BioTherapeutics announced top-line data from the Phase III MMPOWER-3 trial evaluating Ocuvia (elamipretide) for treatment of patients with primary mitochondrial myopathy (PMM). The study did not meet its primary endpoints assessing changes in the six-minute walk test and Primary Mitochondrial Myopathy Symptom Assessment (PMMSA) Total Fatigue Score. Safety results showed that treatment with elamipretide was well tolerated with most adverse events mild to moderate in severity.

MMPOWER-3 was a randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of elamipretide over 32 weeks in 218 patients with primary mitochondrial myopathy between the ages of 16 and 80. The trial was conducted at 28 clinical sites across North America, Europe and Australia.