Stealth BioTherapeutics Looks Ahead To Phase III In Mitochondrial Disease

 
• By Alex Shimmings
  
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Stealth BioTherapeutics is planning Phase III trials on the back of positive Phase II data for its lead product elamipretide in the rare indication of mitochondrial dysfunction, a disease for which there no currently approved treatments.

The private Boston, Massachusetts-based biopharmaceutical company presented the results of its MMPOWER study at the United Mitochondrial Disease Foundation symposium in Seattle last week, evaluating systemic elamipretide for the treatment of primary mitochondrial myopathy (muscle weakness) in 36 patients with a genetically confirmed mitochondrial disease. They showed significant improvements with the product in distance walked in six minutes, the study’s primary endpoint.

At the highest dose studied, 0.25 mg/kg/hr, was associated with a significant improvement in the six-minute walk test (6 MWT),...

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