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     159  0 Kommentare Kezar Highlights Broad Therapeutic Potential of KZR-616 During ACR Convergence 2020 - Seite 2

    “These two presentations strengthen our understanding of how KZR-616 can be an effective treatment for patients with a variety of autoimmune diseases. The preclinical data show the importance of the immunoproteasome in the pathology of myositis and the ability of KZR-616 to selectively inhibit this important regulator of immune function for therapeutic benefit. The clinical data continues to show that KZR-616 is well- tolerated and improves multiple signs and symptoms of SLE. We continue to build a strong foundation for KZR-616 as a novel and important therapeutic for patients living with LN, dermatomyositis and polymyositis and other immune-mediated diseases,” said Noreen Henig, M.D., Kezar’s Chief Medical Officer.

    About MISSION

    MISSION (NCT03393013) is a Phase 1b/2 clinical trial evaluating KZR-616 in SLE patients with and without nephritis. The study consists of two parts. The Phase 1b portion is an open-label dose escalation study which is evaluating doses up to 75 mg of KZR-616 across 6 cohorts, which has completed enrollment. The primary objective of the Ph1b portion of MISSION is to assess safety and tolerability. Secondary objectives include evaluating pharmacokinetics (PK) and pharmacodynamics (PD) and selecting dose levels for the Phase 2 trials. Several exploratory efficacy measures are also being assessed: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), Cutaneous Lupus Erythematosus Severity Index-Activity (CLASI-A), Tender and Swollen Joint Counts (TJC/SJC), Physician Global Assessment (PhGA), Patient Global Assessment (PtGA) and Patient Assessment of Pain (PtP). The Phase 2 portion of the MISSION study evaluating KZR-616 in patients with LN is currently enrolling.

    About PRESIDIO

    PRESIDIO (NCT04033926) is a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, PK and PD of treatment with KZR-616 in patients with active polymyositis or dermatomyositis. During the 32-week treatment period, patients will receive either KZR-616 or placebo subcutaneously once weekly for 16 weeks followed by a crossover to the other treatment arm for an additional 16 weeks. The study is expected to enroll 24 patients. An open-label extension study of PRESIDIO is now also enrolling.

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    Kezar Highlights Broad Therapeutic Potential of KZR-616 During ACR Convergence 2020 - Seite 2 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today highlighted the broad therapeutic potential of KZR-616, a …