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Combination therapy for treating hepatitis b virus infection

A technology for hepatitis B virus and disease, which is applied in the field of treating hepatitis B virus infection or inhibiting the expression of at least one hepatitis B virus gene, and can solve problems such as lack of

Pending Publication Date: 2022-02-18
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This leads to the formation of HBV capsids lacking HBV DNA or RNA (non-functional capsids) and ultimately to inhibition of HBV replication

Method used

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  • Combination therapy for treating hepatitis b virus infection
  • Combination therapy for treating hepatitis b virus infection
  • Combination therapy for treating hepatitis b virus infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0236] Embodiment 1 A method for inhibiting hepatitis B virus gene expression in a subject in need thereof, wherein the method comprises administering to the subject an effective amount of an RNAi component and a compound of formula (I), wherein :

[0237] (a) the RNAi component comprises

[0238] (i) a first RNAi agent comprising: an antisense strand comprising any one of the nucleotide sequences of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: ID NO: 5, SEQ ID NO: 6 and SEQ ID NO: 7, and the sense strand comprising any of the nucleotide sequences of: SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14 and SEQ ID NO: 15; and

[0239] (ii) a second RNAi agent comprising: an antisense strand comprising any of the following nucleotide sequences: SEQ ID NO: 8 and SEQ ID NO: 9, and any of the following nucleotide sequences comprising: Sense strand: SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18 and SEQ ID NO: 1...

Embodiment approach 2

[0243] Embodiment 2 A method for treating a disease or condition associated with an infection caused by hepatitis B virus in a subject, wherein the method comprises administering to the subject an effective amount of the RNAi component and formula (I) compounds, of which:

[0244] (a) the RNAi component comprises

[0245] (i) a first RNAi agent comprising: an antisense strand comprising any one of the nucleotide sequences of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: ID NO: 5, SEQ ID NO: 6 and SEQ ID NO: 7, and the sense strand comprising any of the nucleotide sequences of: SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14 and SEQ ID NO: 15; and

[0246] (ii) a second RNAi agent comprising: an antisense strand comprising any of the following nucleotide sequences: SEQ ID NO: 8 and SEQ ID NO: 9, and any of the following nucleotide sequences comprising: Sense strand: SEQ ID NO: 16, SEQ ID NO: 17, SEQ I...

Embodiment approach 3

[0250] Embodiment 3 A method of treating a disease or condition associated with an infection caused by hepatitis B virus in a subject receiving capsid assembly modulator therapy, wherein:

[0251] The capsid assembly modulator therapy is a compound of formula (I):

[0252] ,

[0253] or a pharmaceutically acceptable salt thereof; and

[0254] The method comprises administering to the subject an effective amount of an RNAi component, wherein the RNAi component comprises

[0255] (i) a first RNAi agent comprising: an antisense strand comprising any one of the nucleotide sequences of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: ID NO: 5, SEQ ID NO: 6 and SEQ ID NO: 7, and the sense strand comprising any of the nucleotide sequences of: SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14 and SEQ ID NO: 15; and

[0256] (ii) a second RNAi agent comprising: an antisense strand comprising any of the followin...

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PUM

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Abstract

Described are RNA interference (RNAi) agents for inhibiting the expression of Hepatitis B Virus (HBV) used in combination with a capsid assembly modulator (CAM) and methods of administering same. The HBV RNAi agents and CAMs are administered in ratios to effectively inhibit HBV gene expression and to treat diseases and conditions associated with HBV infection.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority of: U.S. Provisional Patent Application Serial No. 62 / 836,066, filed April 18, 2019; U.S. Provisional Patent Application Serial No. 62 / 852,749, filed May 24, 2019; PCT Patent Application No. PCT / US2019 / 046036, filed August 9; and U.S. Provisional Patent Application Serial No. 62 / 932,346, filed November 7, 2019; the contents of each of which are incorporated herein by reference in their entirety. [0003] ASCII text file sequence listing submission [0004] The contents of the following submission of ASCII text file are incorporated herein by reference in their entirety: Sequence Listing in Computer Readable Format (CRF) (File Name: 165002000941SEQLIST.TXT, Date of Record: April 17, 2020, Size: 8 KB). technical field [0005] The present disclosure relates generally to compositions and kits comprising RNA interference (RNAi) components and capsid assembly modulators, and th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/401A61K31/713A61P31/20
CPCA61K31/713A61K31/675A61K31/708A61K31/40A61K9/0019A61P31/00A61K9/0053
Inventor M·比尔默R·C·M·卡尔迈耶K·A·西门M·G·博蒙特O·伦兹J·斯诺伊斯
Owner JANSSEN PHARMA NV