Use of Anti-il-36r antibodies for treatment of generalized pustular psoriasis
A pustular and generalized technology, applied in the field of anti-IL-36R antibody for the treatment of generalized pustular psoriasis, which can solve the problems of no clearly defined endpoint and long-term use of treatment
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Embodiment 1
[1028] Example 1: IL-36 receptor inhibition for the treatment of generalized pustular psoriasis
[1029] The antibodies of the invention, the anti-IL-36R antibodies of the invention (disclosed herein and in US Pat. No. 9,023,995), are humanized antagonistic monoclonal IgGl antibodies that block human IL36R signaling. It is expected that binding of the anti-IL-36R antibodies of the invention to IL36R will prevent subsequent activation of IL36R by the cognate ligands (IL36α, β and γ) and activation of downstream pro-inflammatory and pro-fibrotic pathways, with the aim of reducing epithelial / Fibroblast / immune cell-mediated inflammation and disruption of the inflammatory response that drives pathogenic cytokine production in generalized pustular psoriasis (GPP).
[1030] The preclinical profile of the anti-IL-36R antibody of the present invention and clinical data from trials in healthy volunteers indicate that the anti-IL-36R antibody of the present invention is safe, tolerable,...
Embodiment 2
[1130] Example 2: Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Study to Evaluate Anti-IL-36R Antibodies of the Invention in Generalized Pustular Psoriasis Presenting with Acute Flares of Moderate to Severe Intensity Efficacy, Safety and Tolerability in (GPP) Patients
[1131] Current treatment options for controlling acute GPP, completely resolving symptoms, and preventing recurrence of flares are limited and do not provide sustained efficacy. Although a combination of retinoids, cyclosporine, or methotrexate is still recommended as the primary option for controlling chronic GPP exacerbations, no treatments are currently approved for GPP in the US and EU. However, the long-term use of these treatments is limited due to side effects and contraindications (retinoids: teratogenicity, alopecia; cyclosporine: excessive hair growth, nephrotoxicity; MTX: hepatotoxicity). Side effects such as alopecia, excessive hair growth, and teratogenicity limit the use of t...
Embodiment 3
[1147] Example 3: Treating a Patient Suffering from Acute GPP Flares
[1148] In this example, an anti-IL36R antibody (eg, an anti-IL-36R antibody of the invention) is used to treat a patient with an acute GPP flare. Initially, each patient had one or more of the entry criteria listed in Example 2. A single 900 mg dose i.v. of an anti-IL36R antibody of the invention (as an infusion solution at 60 mg / mL) was administered to each patient.
[1149] Following administration of an anti-IL-36R antibody (e.g., an anti-IL-36R antibody of the invention), safety and efficacy assessments show the following: at least 10%, 11%, 12%, 13%, 14%, 15% , 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32 %, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65% , 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82 %, 83%,...
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