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New Evidence Published in Muscle and Nerve on Measuring 6-Minute Walk Distance in Duchenne Muscular Dystrophy
Date:8/26/2013

SOUTH PLAINFIELD, N.J., Aug. 26, 2013 /PRNewswire/ -- Data published in the medical journal Muscle & Nerve demonstrate the clinical meaningfulness of the 6-minute walk test (6MWT) as a primary endpoint to measure disease progression and walking ability in ambulatory Duchenne muscular dystrophy (DMD) trials. The research also showed that a range of 20 to 30 meters in walking ability is a clinically meaningful change, as measured by 6-minute walk distance (6MWD). This analysis is based on natural history data obtained from PTC Therapeutics' Phase 2b trial of ataluren in 174 patients with nonsense mutation Duchenne muscular dystrophy (nmDMD), the first placebo-controlled, multi-national study of a new chemical entity for DMD.

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"Given that several novel approaches to the treatment of Duchenne muscular dystrophy have shown promise in preclinical and/or proof-of-concept clinical studies, the research community has faced the need to identify and develop clinically meaningful outcome measures for use in pivotal therapeutic trials. In boys with DMD, walking abnormalities are a major disease manifestation that have great importance to patients and their families," stated Dr. Craig McDonald, one of the world's leading experts in muscular dystrophy clinical endpoints and DMD natural history studies and lead author of the two publications. "We pioneered the development of the 6MWT for DMD with PTC in conjunction with the ataluren trials and I am pleased to have collaborated with the ataluren study group to demonstrate the 6MWT as a reliable, valid, and meaningful endpoint for Duchenne muscular dystrophy." Dr. McDonald added, "The data from the ataluren placebo group has recently been replicated in other natural history studies conducted by investigators i
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SOURCE PTC Therapeutics, Inc.
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