Shots:

• The P-III (EMBARK: N=126) study was carried out in 2 parts, with P1 involving ambulatory DMD boys (n=63; 4-7yrs.) to receive Elevidys (1.33x10^14 vg/kg) vs PBO while P2 involved crossing over of the patients (5-9yrs.); 59 crossed over to Elevidys post 52wks.
• Parts 1 (post 2yrs.) & 2 (post 1yr.) depicted improved NSAA by +2.88 & +2.34 points; TTR by -2.06 & -2.70 sec as well as 10MWR by -1.36 & -1.07 sec, respectively. Full data will be shared at future meetings
• Muscle biopsies at 64wks. after dosing in P1 showed sustained micro-dystrophin expression & minimal progression in muscle pathology; Review is ongoing in the EU, Japan, Switzerland, Singapore, Hong Kong & Saudi Arabia

Ref: Roche | Image: Roche

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