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Santhera and ReveraGen Announce New 2.5-year Treatment Data with Vamorolone in Duchenne .
Santhera Pharmaceuticals Holding AGApril 28, 2021 GMT Pratteln, Switzerland, April 28, 2021 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen Biopharma announce new clinical data of 2.5-year treatment outcome with vamorolone in patients with Duchenne muscular dystrophy (DMD). These Phase 2a long-term treatment data demonstrate a maintenance of treatment effect, equivalent to a delay of about two years in decline for time to stand (TTSTAND) velocity, and confirm safety and tolerability benefits of vamorolone over the 2.5-year follow up period. Long-term treatment with vamorolone resulted in significantly fewer corticosteroid-associated adverse events than reported in other clinical trials with other steroids.
Santhera Pharmaceuticals Holding AG: Santhera and ReveraGen Announce New 2.5-year Treatment Data with Vamorolone in Duchenne Muscular Dystrophy
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A sequence of studies investigated the safety, tolerability and long-term treatment benefit with vamorolone and provide open-label data in a total of 46 patients with DMD, aged 4 to up to 10 years (start/end of treatment), of which 41 (89%) completed a 2.5 years treatment period. 48 participants initially completed a two-week multiple ascending dose trial VBP15-002 [1], 46 of whom entered the open-label 6-month extension VBP15-003 [2], covering a dose range of vamorolone of 0.25 to 6.0 mg/kg/day. All of the 46 patients completing the latter study entered the 24-month long-term extension study VBP15-LTE [3] where all patients eventually received doses of vamorolone of 2.0 to 6.0 mg/kg/day. The total exposure to vamorolone treatment in these studies was 113 patient years. The most commonly administere
Santhera and ReveraGen Announce New 2.5-year Treatment Data with Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, April 28, 2021 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen Biopharma announce new clinical data of 2.5-year treatment outcome with vamorolone in patients with Duchenne muscular dystrophy (DMD). These Phase 2a long-term treatment data demonstrate
a maintenance of treatment effect, equivalent to a delay of about two years in decline for
time to stand (TTSTAND) velocity, and confirm safety and tolerability benefits of vamorolone over the 2.5-year follow up period.
Long-term treatment with vamorolone resulted in significantly fewer corticosteroid-associated adverse events than reported in other clinical trials with other steroids.
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Image Credit: TRMK / Shutterstock.com
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