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     130  0 Kommentare Kiniksa Announces Positive Data from Phase 2 Trial of Mavrilimumab in Giant Cell Arteritis

    - Primary and secondary efficacy endpoints statistically significant -

    HAMILTON, Bermuda, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of clinical-stage assets designed to modulate immunological pathways across a spectrum of diseases, announced positive data from the global Phase 2 trial of mavrilimumab in giant cell arteritis (GCA). Mavrilimumab is an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα). The trial achieved both the primary and secondary efficacy endpoints with statistical significance.

    “We are thrilled to report that both the primary and secondary efficacy endpoints in the Phase 2 trial of mavrilimumab in giant cell arteritis achieved statistical significance,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “These data suggest mavrilimumab may offer a treatment option for patients suffering from giant cell arteritis and further demonstrate the potential broad utility of mavrilimumab. We look forward to presenting additional data from this study in a publication or at a future medical conference.”

    The randomized, double-blind, placebo-controlled, global Phase 2 trial consists of a 6-week screening period, a 26-week double-blind placebo-controlled treatment period, and a 12-week washout safety follow-up period. Patients age 50 to 85 years with active GCA, confirmed by temporal artery biopsy and/or imaging, with erythrocyte sedimentation rate (ESR) ≥ 30 mm/hour or C-reactive protein (CRP) ≥ 1 mg/dL, and symptoms of GCA within 6 weeks from randomization, were included. All patients were required to have achieved corticosteroid-induced remission (resolution of symptoms, ESR < 20 mm/hour, CRP < 1 mg/dL) prior to randomization. Seventy (70) patients were randomized 3:2 to mavrilimumab 150 mg or placebo biweekly injected subcutaneously, co-administered with a protocol-defined 26-week oral corticosteroid taper. Patients were stratified by new onset (n=35) or relapsing/refractory (n=35) disease. The co-principal investigators are Dr. Maria Cid, Hospital Clínic, University of Barcelona, IDIBAPS, and Dr. Sebastian Unizony of Massachusetts General Hospital, Harvard University.

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    Kiniksa Announces Positive Data from Phase 2 Trial of Mavrilimumab in Giant Cell Arteritis - Primary and secondary efficacy endpoints statistically significant -HAMILTON, Bermuda, Oct. 06, 2020 (GLOBE NEWSWIRE) - Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of clinical-stage …