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    Home > Active Ingredient News > Drugs Articles > Promoted Oral Alzheimer's Disease Phase 3 Clinical Trial

    Promoted Oral Alzheimer's Disease Phase 3 Clinical Trial

    • Last Update: 2022-06-13
    • Source: Internet
    • Author: User
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    A few days ago, Alzheon announced the completion of a $50 million Series D financing, which will be used to accelerate the Phase 3 clinical trial APOLLOE4 of its oral investigational therapy ALZ-801 (valiltramiprosate) for the treatment of early Alzheimer's disease, and potential Regulatory applications
    .
    At the same time, the company will initiate studies of ALZ-801 in other Alzheimer's disease patient populations, as well as in healthy individuals at risk of developing the disease
    .

    ALZ-801 is an oral drug in Phase 3 clinical development that blocks the formation of soluble amyloid oligomers associated with cognitive decline in Alzheimer's disease process potential
    .
    Mechanism of action studies have demonstrated that ALZ-801 completely inhibits the formation of amyloid oligomers at doses used in Phase 3 clinical trials
    .

    In February, the company announced positive biomarker results from a Phase 2 clinical trial of ALZ-801
    .
    After 6 months of treatment, patients with Alzheimer's disease achieved clinically relevant and statistically significant reductions in plasma biomarkers
    .
    The patient also experienced improved memory
    .

    The results of the phase 2 clinical trial including 80 patients showed that the plasma p-tau181 level in the ALZ-801 group was significantly reduced by 29% (p=0.
    028) at week 26 and by 18% at week 13 (p=0.
    038)
    .
    ALZ-801 also significantly reduced the plasma p-tau181/Aβ42 ratio by 30% at week 26 (p=0.
    022) and by 21% at week 13 (p=0.
    018)
    .
    Phosphorylated tau protein (p-tau) levels in plasma and cerebrospinal fluid are sensitive and specific markers of brain damage and neurodegeneration in Alzheimer's disease
    .
    Given the importance of p-tau181 and Aβ42 as core Alzheimer's disease pathological biomarkers, these results support a disease-modifying role for ALZ-801 in Alzheimer's disease
    .

    In addition to biomarker results, the Phase 2 clinical study also included the Rey Auditory Verbal Learning Test (RAVLT) as a secondary endpoint
    .
    Analysis of the RAVLT total memory score (including immediate and delayed recall) showed a significant improvement from baseline to week 26 (p=0.
    002)
    .

    Martin Tolar, founder, president and CEO of Alzheon, said: "Alzheon develops differentiated solutions for the treatment and prevention of Alzheimer's disease
    .
    Our small molecule platform targets the same pathway as anti-amyloid antibodies, But generating work upstream that blocks the formation of neurotoxic soluble amyloid oligomers without disrupting insoluble plaque deposition
    .
    This may reduce brain edema and microbleeds
    .
    This Series D financing and recent clinical trial data will accelerate ALZ -801 development
    .
    It has the potential to be the first oral therapy to delay or even stop disease pathology
    .
    "

    References:

    References:

    [1] Alzheon Announces Closing of Oversubscribed $50 Million Series D Financing Round to Accelerate Completion of APOLLOE4 Phase 3 Trial and Expansion of Product Portfolio.
    Retrieved April 14, 2022, from https:// /en

    [1] Alzheon Announces Closing of Oversubscribed $50 Million Series D Financing Round to Accelerate Completion of APOLLOE4 Phase 3 Trial and Expansion of Product Portfolio.
    Retrieved April 14, 2022, from https:// /en
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