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  • PBC - Exploring Data On Emerging Treatments For Primary Biliary Cholangitis

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    giorgi popiashvili
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    The document discusses several potential treatments for primary biliary cholangitis (PBC) that target the peroxisome proliferator-activated receptor (PPAR) pathway or other targets. It reviews results from clinical trials on fibrates like bezafibrate, non-fibrate PPAR agonists like seladelpar and elafibranor, and other drugs targeting PPAR or other pathways such as saroglitazar, tropifexor, linerixibat, and volixibat. Many of these drugs showed improvements in biomarkers of PBC or symptoms like pruritus in Phase 2 or 3 clinical trials and warrant further study as potential new treatments for PBC.

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    PBC.Exploring Data on Emerging Treatments for Primary Biliary Cholangitis

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    The document discusses several potential treatments for primary biliary cholangitis (PBC) that target the peroxisome proliferator-activated receptor (PPAR) pathway or other targets. It reviews results from clinical trials on fibrates like bezafibrate, non-fibrate PPAR agonists like seladelpar and elafibranor, and other drugs targeting PPAR or other pathways such as saroglitazar, tropifexor, linerixibat, and volixibat. Many of these drugs showed improvements in biomarkers of PBC or symptoms like pruritus in Phase 2 or 3 clinical trials and warrant further study as potential new treatments for PBC.

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    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
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    10 views51 pages

    PBC - Exploring Data On Emerging Treatments For Primary Biliary Cholangitis

    Uploaded by

    giorgi popiashvili
    The document discusses several potential treatments for primary biliary cholangitis (PBC) that target the peroxisome proliferator-activated receptor (PPAR) pathway or other targets. It reviews results from clinical trials on fibrates like bezafibrate, non-fibrate PPAR agonists like seladelpar and elafibranor, and other drugs targeting PPAR or other pathways such as saroglitazar, tropifexor, linerixibat, and volixibat. Many of these drugs showed improvements in biomarkers of PBC or symptoms like pruritus in Phase 2 or 3 clinical trials and warrant further study as potential new treatments for PBC.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 51

    Program Agenda

    PBC Overview
    Contributing Factors in PBC
    FDA-Approved Treatments for PBC
    FDA-Approved Treatments for PBC
    Selected Therapeutic Targets in PBC
    Drugs Approved or Under Evaluation for the
    Treatment of PBC
    PPAR-Targeted Therapies in PBC
    Clinical Development
    Other Therapeutic Targets in PBC
    Targeting the PPAR Pathway in PBC
    Fibrates
    Bezafibrate in PBC -- BEZURSO Phase 3
    Trial
    Efficacy Results
    Bezafibrate in PBC -- BEZURSO Phase 3
    Trial
    Safety
    Non-Fibrate PPAR Agonists
    Non-Fibrate PPAR Agonists
    Non-Fibrate PPAR Agonists
    Non-Fibrate PPAR Agonists
    Seladelpar in PBC
    ENHANCE Trial
    Seladelpar in PBC: Randomized Phase 3 Trial
    Efficacy Results
    Seladelpar in PBC: Randomized Phase 3 Trial
    Safety Results
    Improvement in Pruritus With Seladelpar in PBC
    Open-Label, Uncontrolled, Phase 2 Study
    Elafibranor in PBC: Randomized Phase 2
    Study
    Elafibranor in PBC: Randomized Phase 2
    Study
    Reduction in ALP
    Elafibranor in PBC: Randomized Phase 2
    Study
    Response Rates
    Elafibranor in PBC: Randomized Phase 2
    Study
    Safety and Tolerability
    Saroglitazar
    Proof-of-Concept Study in PBC
    Saroglitazar Phase 2 Study in PBC
    Efficacy
    Saroglitazar Phase 2 Study in PBC
    Efficacy
    Saroglitazar Phase 2 Study in PBC
    Efficacy
    Saroglitazar Phase 2 Study in PBC
    Efficacy
    Saroglitazar Phase 2 Study in PBC
    Effect on Pruritis
    Saroglitazar Phase 2 Study in PBC
    Safety
    Concluding Remarks
    Concluding Remarks (cont)
    Drugs Approved or Under Evaluation for the
    Treatment of PBC
    Tropifexor in PBC
    Phase 2 Study
    Tropifexor in PBC: Randomized Phase 2
    Study
    Efficacy and Safety
    Linerixibat in PBC With Pruritis
    Linerixibat in PBC With Pruritis
    Phase 2b Study (GLIMMER)
    Linerixibat Phase 2b Study (GLIMMER)
    Improvement in Pruritis at Week 16 (Per Protocol Analysis)
    Linerixibat Phase 3 Study (GLISTEN)
    Study Design
    Volixibat in PBC With Pruritis
    Phase 2 Study (VANTAGE)
    Other Novel Therapies Being Studied for
    PBC
    NOX1/4 inhibitors
    Setanaxib (GKT831) NOX1/4 Inhibitor in
    PBC
    Phase 2 Study Interim Results
    Other Agents Under Investigation in PBC
    Conclusion

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