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ARTICLE | Clinical News

Stealth reports Phase II extension trial data of elamipretide in mitochondrial myopathy

July 13, 2017 11:57 PM UTC

Stealth BioTherapeutics Inc. (Newton, Mass.) reported data from 30 patients with primary mitochondrial myopathy in the Phase II MMPOWER-2 extension trial showing that once-daily 40 mg subcutaneous elamipretide (MTP-131) missed the primary endpoint of improving 6-minute walk test (6MWT) distance from baseline to week 4 vs. placebo (average improvement of 20 meters over placebo, p=0.08). A prespecified analysis showed that elamipretide improved 6MWT distance from baseline to week 4 by an average of 24 meters in patients with a pretreatment 6MWT distance of <450 meters vs. an average of 8 meters in patients with a pretreatment 6MWT distance of >450 meters.

On secondary endpoints, elamipretide significantly improved NeuroQOL Fatigue Short Form Questionnaire score and Mitochondrial Myopathy Symptom Assessment Total Fatigue score from baseline to week 4 vs. placebo (p=0.01 and p=0.0006, respectively). Elamipretide was well tolerated with no serious adverse events reported. Data were presented at the Mitochondrial Medicine meeting in Washington, D.C...

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