TREATMENT OF SKIN DISEASES OR DISORDERS BY DELIVERY OF ANTI-OSMRbeta ANTIBODY

An antibody and disease technology, applied in skin diseases, antibody medical components, antibodies, etc., can solve problems such as side effects

Pending Publication Date: 2021-03-19
KINIKSA PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Topically applied corticosteroids are somewhat effective in treating these conditions, but are only partially effective in many cases and have their own significant side effects

Method used

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  • TREATMENT OF SKIN DISEASES OR DISORDERS BY DELIVERY OF ANTI-OSMRbeta ANTIBODY
  • TREATMENT OF SKIN DISEASES OR DISORDERS BY DELIVERY OF ANTI-OSMRbeta ANTIBODY
  • TREATMENT OF SKIN DISEASES OR DISORDERS BY DELIVERY OF ANTI-OSMRbeta ANTIBODY

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0376] Example 1: Effect of anti-OSMRβ antibody on cynomolgus monkeys

[0377] The study in this example was designed to evaluate the single-dose pharmacokinetics and efficacy of anti-OSMRβ antibodies following intravenous (IV) administration in male cynomolgus monkeys. A previous study was performed to determine the dose level of human IL-31 that produced the most consistent and strongest scratching response in male cynomolgus monkeys after intradermal administration. The selected dose level was 3 μg / kg human IL-31, which is a supraphysiological level of the IL-31 cytokine.

[0378] experimental design

[0379] animal choice

[0380] Male cynomolgus monkeys were selected from SNBL USA Livestock. Selected animals were physically examined by a veterinarian. In addition, conduct a behavioral assessment prior to the start of the study to exclude animals that may be overgroomed or have pre-existing skin conditions or alopecia. Only animals that met basic health criteria and w...

Embodiment 2

[0403] Example 2: Anti-OSMRβ antibody treatment of atopic dermatitis

[0404] The study in this example was designed to evaluate the safety, tolerability, PK and immunogenicity of anti-OSMRβ antibody in patients with atopic dermatitis. The study also included exploratory studies of pharmacogenetics and the impact of anti-OSMRβ antibodies on clinical efficacy assessments, gene expression and PD measures.

[0405] Research design

[0406] Anti-OSMRβ antibodies were administered intravenously (IV) to subjects with moderate to severe atopic dermatitis experiencing moderate to severe pruritus. In addition, an anti-OSMRβ antibody was administered subcutaneously (SC) to a group of subjects with moderate to severe atopic dermatitis who experienced moderate to severe pruritus.

[0407] Subjects were entered into one of seven groups as described below. After confirmation of eligibility, subjects were randomized to receive anti-OSMRβ antibody or placebo. In six groups, anti-OSMRβ ant...

Embodiment 3

[0442] Example 3: Treatment of Uremic Pruritus Using Anti-OSMRβ Antibody

[0443] The study in this example was designed to evaluate the safety, tolerability, PK and immunogenicity of anti-OSMRβ antibodies in hemodialysis subjects with uremic pruritus. The study also included exploratory studies of pharmacogenetics and the impact of anti-OSMRβ antibody on clinical effect assessment, gene expression and PD measures.

[0444] Research design

[0445] Anti-OSMRβ antibodies were administered intravenously (IV) to hemodialysis subjects with uremic pruritus.

[0446] Subjects entered a treatment group. After confirmation of eligibility, subjects were randomized to receive either 5 mg / kg or 10 mg / kg of anti-OSMRβ antibody or placebo on Day 0 (the day before a routinely planned hemodialysis session).

[0447] After dosing, subjects must be confined to the clinical research unit for at least 2 days of safety monitoring and intensive PK sampling. PK samples were collected at pre-spe...

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Abstract

The present invention provides, among other things, methods of treating pruritic or inflammatory skin diseases or disorders, or pruritus associated with a disease or disorder, with an anti-OSMRbeta antibody, including methods of treating pruritus, associated with atopic dermatitis, chronic kidney disease-associated pruritus, uremic pruritus or prurigo nodularis, chronic idiopathic pruritus, chronic idiopathic urticaria, chronic spontaneous urticaria, cutaneous amyloidosis, lichen simplex chronicus, plaque psoriasis, lichens planus, inflammatory ichthyosis, mastocytosis and bullous pemphigoid,comprising a step of administering to a subject in need of treatment an anti-OSMRbeta antibody at a therapeutically effective dose and an administration interval for a treatment period sufficient to improve, stabilize or reduce one or more symptoms of the disease or disorder relative to a control.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Patent Application Serial No. 62 / 662,607, filed April 25, 2018, U.S. Provisional Patent Application Serial No. 62 / 718,324, filed August 13, 2018, filed September 14, 2018 U.S. Provisional Patent Application Serial No. 62 / 731,618, filed November 7, 2018, U.S. Provisional Patent Application Serial No. 62 / 757,047, filed August 16, 2018, U.S. Provisional Patent Application Serial No. 62 / 765,033, filed August 16, 2018, filed 2018 U.S. Provisional Patent Application Serial No. 62 / 775,350, filed December 4, 2019, U.S. Provisional Patent Application Serial No. 62 / 789,434, filed January 7, 2019, and U.S. Provisional Patent Application Serial No., filed January 18, 2019 The benefit and priority of Ser. No. 62 / 794,356, the contents of each of which are incorporated herein. [0003] Incorporated by reference into the sequence listing [0004] The contents of the 17.2KB text file named "KPL-00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P17/00A61P17/04C07K16/28
CPCC07K16/2866A61P17/00A61K2039/57C07K2317/76C07K2317/33C07K2317/90A61K31/573A61K45/06A61K2300/00A61P17/04C07K2317/565A61K2039/505A61K2039/545A61K9/0019A61K39/3955A61K2039/54C07K2317/522C07K2317/524C07K2317/526C07K2317/53G01N33/53G01N2333/715G01N2333/54
Inventor J.帕奥里尼R.甘迪Z.米克哈克
Owner KINIKSA PHARMA LTD
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