Santhera Pharmaceuticals Holding AG: Santhera Reports 2020 Annual Results
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uchenne muscular dystrophy (D
. Santhera started 2021 with the strong foundation of a refreshed clinical and operational strategy focused on vamorolone, which we believe can provide significant value to patients, caregivers, and ultimately shareholders. It represents the key foundation for the future of Santhera, which continues to focus on Duchenne muscular dystrophy (DMD) and other rare diseases., said
Dario Eklund, CEO of Santhera. Vamorolone is currently being developed for early stage DMD patients and recent encouraging data leads us to conclude that vamorolone could emerge as a foundational therapy in DMD for all patients irrespective of gene mutation and as a promising alternative to existing corticosteroids. Based on the collective clinical experience so far, we look forward to t
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.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
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