Methods for treating atopic dermatitis by administering an il-4r antagonist

Inactive Publication Date: 2014-03-13
SANOFI BIOTECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]According to certain aspects of the present invention, methods are provided for treating, preventing and/or reducing the severity of symptoms of atopic dermatitis (AD), including moderate-to-severe AD. Certain embodiments of the invention pertain to methods for treating, ameliorating or preventing moderate-to-severe AD in a patient who is resistant to treatment by a topical corticosteroid or a calcineurin inhibitor. In some embodiments, the present invention discloses methods of treating patients with moderate-to-severe AD that is uncontrolled despite treatment with a topical corticosteroid or a calcineurin inhibitor. The methods of the present invention comprise administering to a subject or a patient in need thereof a pharmaceutical composition comprising a therapeutically effective amount of an interleukin-4 receptor (IL-4R) antagonist

Problems solved by technology

Severe disease can be extremely disabling due to major psychological problems, significant sleep loss, and impaired quality o

Method used

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  • Methods for treating atopic dermatitis by administering an il-4r antagonist
  • Methods for treating atopic dermatitis by administering an il-4r antagonist
  • Methods for treating atopic dermatitis by administering an il-4r antagonist

Examples

Experimental program
Comparison scheme
Effect test

example 1

Generation of Human Antibodies to Human IL-4R

[0224]Human anti-hIL-4R antibodies were generated as described in U.S. Pat. No. 7,608,693. Table 1 sets forth the sequence identifiers for the heavy and light chain variable region amino acid sequence pairs, and CDR amino acid sequences, of selected anti-IL-4R antibodies and their corresponding antibody designations.

TABLE 1AntibodySEQ ID NOs:DesignationHCVRHCDR1HCDR2HCDR3LCVRLCDR1LCDR2LCDR3H1H095-a246810121416H1H095-b1846820121416H1H095-c2246824121416H1H097-a2628303234363840H1H097-b4228303244363840H1H097-c4628303248363840H1H093-a5052545658606264H1H093-b6652545668606264H1H093-c7052545672606264H1H093-d7476788082848688H1H093-e9076788092848688H1H093-f9476788096848688H1H094-a98100102104106108110112H1H094-b114100102104116108110112H1H094-c118100102104120108110112H1H096-a122124126128130132134136H1H096-b138124126128140132134136H1H096-c142124126128144132134136H1H098-a146148150152154156158160H1H098-b162148150152164156158160H1H098-c166148150152168156...

example 2

Single Ascending Dose Clinical Trial of Intravenously and Subcutaneously Administered Anti-IL-4R Antibody (mAb1) in Healthy Subjects

A. Study Design

[0226]This study was a randomized, double-blind, placebo-controlled, sequential, single ascending-dose study of intravenous (IV) and subcutaneous (SC) administered mAb1 in healthy subjects. The main purpose of this study was to evaluate the safety and tolerability of intravenously and subcutaneously administered mAb1 in healthy subjects.

[0227]Screening occurred from day −21 to day −3. On day 1 (baseline), subjects were randomized to receive either IV or SC study drug (mAb1 or placebo) infused over a 2-hour period. Subjects returned on days 4, 8, 11, 15, 22, 29, 43, 57 and 85 (end-of-study) for safety assessments and blood sampling for clinical laboratory testing.

[0228]Forty-eight total subjects participated in the study. Four sequential ascending dose cohorts (1.0, 3.0, 8.0, and 12.0 mg / kg) were planned for IV dosing and 2 sequential asce...

example 3

Clinical Trial of Two Different Drug Products of Anti-IL-4R Antibody (mAb1) Following Subcutaneous Administration of Anti-IL-4R Antibody (mAb1) in Healthy Patients

A. Study Design

[0239]This study was a single-center, single-dose, double-blind, randomized, no placebo-controlled study to assess the safety and pharmacokinetic profile of subcutaneous administration of two different anti-IL-4R mAb (mAb1) drug products generated from different cell lines and manufacturing processes. The drug products were provided in 150 mg / mL 2 mL doses, and 300 mg (2 mL) were administered subcutaneously to 30 healthy adults in two parallel groups (15 subjects per group). Subjects included 30 subjects represented by 22 males (73.3%) and 8 females (26.7%) aged 19 to 45 years old, with weights ranging from 54.8 to 94.3 kg.

[0240]Serum concentration of mAb1 was used to determine the following PK parameters: maximum serum concentration (Cmax), area under the [serum concentration versus time] curve from time 0 ...

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Abstract

The present invention provides methods for treating atopic dermatitis (AD). Also provided are methods for improving one or more AD-associated parameter(s), and methods for decreasing the level of at least one AD-associated biomarker in a subject in need thereof. The methods of the present invention comprise administering to a subject in need thereof a pharmaceutical composition comprising an interleukin-4 receptor (IL-4R) antagonist such as an anti-IL-4R antibody.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit under 35 U.S.C. §119(e) of U.S. provisional application Nos. 61 / 697,972, filed on Sep. 7, 2012; 61 / 738,715, filed on Dec. 18, 2012; 61 / 748,588, filed on Jan. 3, 2013; 61 / 764,624, filed on Feb. 14, 2013; 61 / 768,229, filed on Feb. 22, 2013; 61 / 770,091, filed on Feb. 27, 2013; 61 / 782,420, filed on Mar. 14, 2013; and 61 / 816,191, filed on Apr. 26, 2013, and under 35 U.S.C. §119(b) of French application No. 1356759, filed on Jul. 10, 2013, the disclosures of each herein incorporated by reference in their entireties.FIELD OF THE INVENTION[0002]The present invention relates to the treatment and / or prevention of atopic dermatitis and related conditions. More specifically, the invention relates to the administration of interleukin-4 receptor (IL-4R) antagonists to treat or prevent atopic dermatitis in a patient in need thereof.BACKGROUND[0003]Atopic dermatitis (AD) is a chronic / relapsing inflammatory skin disease...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K31/58A61K31/573A61K45/06C07K16/28
CPCA61K39/3955A61K45/06A61K31/58A61K31/573C07K16/2866A61K2039/54C07K2317/21G01N2800/202G01N33/53A61P17/00A61P17/02A61P17/04A61P35/00A61P37/00A61P37/08A61P43/00A61K38/1793A61P29/00G01N33/6854A61K2039/505G01N2800/52A61K39/395C07K16/28A61K38/02
Inventor ARDELEANU, MARIUSGRAHAM, NEILHAMILTON, JENNIFER DAVIDSONKIRKESSELI, STEPHANE C.KUNDU, SUDEEPMING, JEFFREYRADIN, ALLENROCKLIN, ROSS E.WEINSTEIN, STEVEN PAUL
Owner SANOFI BIOTECH
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