Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy

June 1, 2021 Auto Bot Clinical Trials, Duchenne muscular dystrophy, P-IIb, Santhera 0

Shots:

  • The P-IIb VISION-DMD study involves assessing the efficacy & safety of vamorolone (2&6 mg/kg/day) vs PBO and prednisone (0.75 mg/kg/day) in 121 ambulant boys aged 4 to <7 years with DMD for 48 wks.
  • The study met its 1EP i.e improvement in TTSTAND velocity, following the 1st period @24 wks. The 2 EPs include 6MWT & TTRW also showed significance over PBO, the therapy showed a favorable safety and tolerability profile over prednisone
  • The company plans to file an NDA with the US FDA in Q1’22 and plans to commercialize the therapy in the US & the EU following the approval. The company has requested the PR based on the FTD granted by the FDA

Click here to­ read full press release/ article | Ref: Santhera | Image: Business Wire

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