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Santhera Announces Publication of Long-Term Clinical Data With Vamorolone in Patients With Duchenne Muscular Dystrophy
Santhera Pharmaceuticals announces that partner ReveraGen Biopharma Inc. and their academic collaborators have published new open-label, long-term clinical data on the safety, tolerability and efficacy of vamorolone in patients with Duchenne muscular dystrophy (DMD). These 18-month treatment data extend previously published 24-week treatment data, and show a reduction of corticosteroid-specific side effects and sustained efficacy with vamorolone including clinical improvement through the 18-month follow-up period.
This publication in the journal PLOS Medicine provides peer-reviewed and detailed open-label data in patients with DMD treated for 18 months with vamorolone. A multi-center, open-label, 24-week trial (VBP15-003) with a total 24-month long-term extension (VBP15-LTE) was conducted by the Cooperative International Neuromuscular Research Group (CINRG) and evaluated drug-related effects of vamorolone on motor outcomes and corticosteroid-associated safety concerns. This publication covers the 24-week Phase 2a trial (VBP15-003) and the first 12 months of the open-label extension trial (VBP15-LTE) adding up to a total treatment period of 18 months.
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