The P-III (EMBARK) trial evaluates the safety & efficacy of Elevidys (1.33×10^14 vg/kg) vs PBO in ambulatory boys (n=125, aged 4 to 7yrs.) with DMD. Even though the results depicted an NSAA score of 2.6 vs 1.9 at 52wks, the 1EPs of the study were not met
For the 2EPs, time to rise from the floor/ascend 4 steps, 10m walk test, stride velocity 95th centile & speed of walking via a wearable Syde, the results showed a clinically meaningful & significant improvement as the LSM difference in time to rise & 10-meter walk test was -0.64sec. & -0.42sec.
Roche is currently assessing Elevidys across different segments of DMD patients in 6 studies incl. Study 101, Study 102, 103 (ENDEAVOR), 302 (ENVOL), 303 (ENVISION) & 305 (EXPEDITION)
Ref: Roche | Image: Roche
Related News:- Sarepta Therapeutics’ Elevidys Receives the US FDA’s Accelerated Approval for the Treatment of Duchenne Muscular Dystrophy
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