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    Home > Medical News > Latest Medical News > Phase 3 clinical results of C3 complement inhibitors for the treatment of age-related macular degeneration released

    Phase 3 clinical results of C3 complement inhibitors for the treatment of age-related macular degeneration released

    • Last Update: 2021-11-05
    • Source: Internet
    • Author: User
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    On September 9, Apellis announced the top-line results obtained in two phase 3 clinical trials, DERBY and OAKS, in the research pegcetacoplan targeting the complement C3 protein
    .
    Two trials evaluated the efficacy and safety of pegcetacoplan in 1258 adult patients with age-related macular degeneration (AMD) with geographic atrophy (GA) through intravitreal injection of pegcetacoplan
    .
    Based on the results obtained, Apellis plans to submit a New Drug Application (NDA) for pegcetacoplan to the US FDA in the first half of 2022
    .
    The press release stated that if approved, pegcetacoplan will become the first treatment for GA
    .

    GA is an advanced form of AMD, and AMD is the main cause of blindness
    .
    GA disease affects the central part of the retina called the macula, which is responsible for central vision
    .
    The irreversible progress of GA will cause central vision damage and permanent vision loss, and there are more than 5 million patients worldwide
    .
    There is currently no approved treatment for GA
    .

    GA occurs because of the excessive activation of the complement cascade in the immune system, and complement C3 is an effective target for precise regulation of complement activation
    .
    Pegcetacoplan is a C3 targeted therapy that has previously been granted Fast Track status by the US FDA for the treatment of GA
    .
    It has been approved by the FDA in May this year to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
    .

    ▲The mechanism of action of Pegcetacoplan (APL-2) (Image source: Apellis official website)

    The test results showed that the OAKS test reached the primary endpoint
    .
    That is, at 12 months, compared with the control group, pegcetacoplan administered once a month or once every two months significantly reduced the growth of GA lesions by 22% (p=0.
    0003) and 16% (p=0.
    0052)
    .
    The DERBY trial did not reach the primary endpoint.
    At 12 months, compared with the control group, the growth of GA lesions in the treatment group once a month or every two months was reduced by 12% (p=0.
    0528) and 11% (p= 0.
    0750)
    .

    A scheduled analysis combining the data of the two trials showed that at 12 months, compared with the control group, the administration of pegcetacoplan once a month or every two months reduced the growth of GA lesions by 17% (p<0.
    0001) and 14% (p=0.
    0012)
    .

    Moreover, in the pre-analysis of the primary endpoint, pegcetacoplan showed greater utility in patients with extrafoveal lesions at baseline
    .
    GA patients usually present with lesions outside the fovea first, and then progress to the fovea where central vision is affected
    .
    Combining the data of the two studies, at 12 months, compared with the control group, pegcetacoplan administered once a month or once every two months reduced the growth of GA lesions in patients with extrafoveal lesions by 26% (p<0.
    0001) ) And 23% (p=0.
    0002)
    .

    Note: The original text has been deleted

    Reference materials:

    [1] Apellis Announces Top-Line Results from Phase 3 DERBY and OAKS Studies in Geographic Atrophy (GA) and Plans to Submit NDA to FDA in the First Half of 2022.
    Retrieved September 9, 2021, from https:// .
    com/news-release/2021/09/09/2294782/0/en/Apellis-Announces-Top-Line-Results-from-Phase-3-DERBY-and-OAKS-Studies-in-Geographic-Atrophy-GA -and-Plans-to-Submit-NDA-to-FDA-in-the-First-Half-of-2022.
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