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    Home > Biochemistry News > Biotechnology News > DMD innovative therapies reach key clinical trial endpoints, new drug applications are expected to be submitted early next year

    DMD innovative therapies reach key clinical trial endpoints, new drug applications are expected to be submitted early next year

    • Last Update: 2021-06-04
    • Source: Internet
    • Author: User
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    Today, Santhera Pharmaceuticals and ReveraGen BioPharma jointly announced that the innovative therapy vamorolone has reached the primary endpoint and multiple key secondary endpoints in a pivotal Phase 2b clinical trial for the treatment of patients with Duchenne muscular dystrophy (DMD).


    DMD is one of the most common childhood neuromuscular diseases.


    Vamorolone is a potential "first-in-class" steroid drug originally developed by ReveraGen Biopharma.


    ▲The mechanism of action of Vamorolone (picture source: Santhera's official website)

    In this phase 2b clinical trial, a total of 121 DMD patients aged 4-7 years were randomized to receive different doses of vamorolone, placebo or prednisone.


    Vamorolone reached the primary endpoint of the trial.


    ▲Vamorolone significantly improves the speed of patients from supine to standing (picture source: reference [1])

    In addition, compared with the placebo group, two different doses of vamorolone also significantly improved the patient's 6-minute walk test (6-MWT) indicators.


    ▲Vamorolone significantly improved the patient's 6-minute walk test indicators (picture source: reference [1])

    In terms of safety, compared with prednisone, vamorolone caused fewer treatment-related adverse events.


    ▲Compared with prednisone, Vamorolone did not show the effect of delaying the growth of children (picture source: reference [1])

    Note: The original text has been deleted

    Reference materials:

    [1] Presentation on VISION-DMD topline readout with vamorolone.


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