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Compositions and methods for treating immune thrombocytopenia

A technology for thrombocytopenia, immunology, applied in the therapeutic field

Pending Publication Date: 2021-03-16
ARGENX BVBA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] With the exception of splenectomy, many of the treatment options available today generally produce only short-term and modest improvements in platelet counts in patients with ITP

Method used

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  • Compositions and methods for treating immune thrombocytopenia
  • Compositions and methods for treating immune thrombocytopenia
  • Compositions and methods for treating immune thrombocytopenia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0153] Example 1: Single Dose Toxicity Study of ARGX-113 in Cynomolgus Monkeys

[0154] Four dose levels (10 mg, 30 mg, 50 mg, and 100 mg per kg body weight [b.w.]) of ARGX-113 and controls were administered to cynomolgus monkeys by 2-hour intravenous infusion. No signs of local intolerance associated with ARGX-113 were observed at any dose level tested. No associations with ARGX- 113 related effects. Furthermore, no macroscopic or microscopic systemic organ changes were observed in any of the animals examined, and in particular no histopathological changes were observed in the liver of monkeys at any dose level tested.

[0155] Administration of ARGX-113 caused significant changes in biochemical parameters that were not considered adverse in nature. A decrease in the serum concentration of γ-globulin was observed in all ARGX-113 treated groups. Since ARGX-113 increases antibody clearance by binding to the FcRn receptor, the decrease in total immunoglobulins (gamma-globuli...

Embodiment 2

[0157] Example 2: Repeated Dose Toxicity Study of ARGX-113 in Cynomolgus Monkeys

[0158] In a 1-month repeat-dose toxicology study in cynomolgus monkeys, ARGX-113 was administered at 3 dose levels (3 mg / kg, 30 mg / kg, and 100 mg / kg). Ten animals, 5 male and 5 female cynomolgus monkeys, were treated at each dose level and received intravenous infusions of ARGX-113 every 48 hours for a total of 15 infusions. ARGX-113 was well tolerated by all animals at all doses as determined by clinical signs, body weight, macroscopic examination, histopathology, food consumption, and hematological and serum biochemical parameters. No macroscopic changes associated with ARGX-113 were observed. Histopathological examination revealed changes in the liver at a dose of 100 mg / kg ARGX-113. Liver changes included cytoplasmic changes and degeneration and a diffuse mixed inflammatory cell infiltration. There were no liver lesions in animals in the 100 mg / kg dose group at the end of the treatment-fr...

Embodiment 3

[0167] Example 3: Repeated Dose Toxicity Study of ARGX-113 in Rats

[0168] In a 1-month repeated-dose toxicology study in rats, ARGX-113 was administered at 3 dose levels (10 mg / kg, 30 mg / kg, and 100 mg / kg). Twenty animals, ten males and ten females, were treated at each dose level and received intravenous injections of ARGX-113 every 48 hours for a total of 15 infusions. ARGX-113 was well tolerated by all animals at all doses as determined by clinical signs, body weight, macroscopic examination, histopathology, food consumption, and hematological and serum biochemical parameters. No macroscopic changes associated with ARGX-113 were observed. Histopathological examination revealed test article-related histopathological lesions in the liver at doses of 100 mg / kg ARGX-113 in some animals. The lesion consisted of Kupffer cell hypertrophy / hyperplasia, which was observed in both females and males in the 100 mg / kg ARGX-113 treated group. There were no liver lesions in animals in...

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Abstract

A method is disclosed for the treatment of human subjects diagnosed with immune thrombocytopenia (ITP). The method comprises administering to a human subject a human neonatal Fc receptor (hFcRn) antagonist, optionally in combination with standard-of-care ITP treatment. In certain embodiments, the hFcRn antagonist is efgartigimod (ARGX-113). Standard-of-care ITP treatment may comprise administration of corticosteroids, immunosuppressants, and / or thrombopoietin receptor (TPO-R) agonists.

Description

[0001] related application [0002] This application claims U.S. Application No. 62 / 682,805, filed June 8, 2018, U.S. Application No. 62 / 731,947, filed September 16, 2018, and U.S. Application No. 62 / 732,414, filed September 17, 2018 The entire contents of each of these US applications are incorporated herein by reference for the benefit of priority. [0003] sequence listing [0004] This application contains a Sequence Listing, which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. The ASCII copy created on June 6, 2019 is named 613052_AGX5-045PC_ST25.txt and has a size of 8,254 bytes. technical field [0005] The present invention relates generally to the treatment of immune thrombocytopenia (ITP), and more particularly to methods of treatment comprising the administration of an FcRn antagonist, optionally in combination with standard-of-care treatments for ITP. Background technique [0006] Immune thrombocytope...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/00A61K31/573A61P7/04
CPCC07K16/00C07K2317/52A61K2039/505A61P7/04A61K31/573A61K45/06A61K31/4152A61K31/675A61K2300/00C07K14/4703C07K16/283C07K2317/41A61K38/13A61K31/145A61K31/52A61K38/196
Inventor H·德哈德彼得·乌尔里希茨T·卡辛N·勒平托尔斯滕·德赖尔T·万布莱格特
Owner ARGENX BVBA
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