Roche Reports the Results of Elevidys in P-III Trial for the Treatment of Duchenne Muscular Dystrophy (DMD)
Shots:
- The P-III (EMBARK) trial evaluates the safety & efficacy of Elevidys (1.33x10^14 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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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
