Therapeutic methods for treating hepatitis b

A kind of technology of hepatitis B, use, applied in the therapeutic field for treating hepatitis B

Pending Publication Date: 2021-12-31
阿布特斯生物制药公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Co-infection with HBV and HDV leads to more serious complications than HBV infection alone

Method used

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  • Therapeutic methods for treating hepatitis b
  • Therapeutic methods for treating hepatitis b
  • Therapeutic methods for treating hepatitis b

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[1942] In one embodiment, the methods of the present invention exclude a method of treating hepatitis B in an animal comprising administering to the animal a synergistically effective amount of i) an inhibitor of formation of covalently closed circular DNA and ii) a nucleoside or nucleotide analogs.

[1943] In one embodiment, the pharmaceutical compositions of the present invention exclude compositions comprising as the only active hepatitis B therapeutics: i) inhibitors of covalently closed circular DNA formation and ii) nucleosides or nucleotides analog.

[1944] In one embodiment, the kits of the present invention exclude kits comprising as the sole hepatitis B agent: i) inhibitors of covalently closed circular DNA formation and ii) nucleoside or nucleotide analogs.

[1945] In one embodiment, the methods of the present invention exclude a method of treating hepatitis B in an animal comprising administering to the animal i) one or more siRNAs targeting hepatitis B virus a...

Embodiment 1-4

[2260] Materials and methods for combinatorial studies in primary human hepatocytes (PHH) are described in Examples 1-4 below.

[2261] PHH

[2262] Cryopreserved PHH (Lot IKB) was purchased from Bioreclamation IVT

[2263] test item

[2264] Compounds (V), (VI) and (VII) were produced by Arbutus Biopharma. Pegylated IFN-α2a and TAF are commercially available. Information on the compounds is shown in Table 1.

[2265] Table 1. Information on Test Items

[2266]

[2267] infectious virus stock

[2268] Type D HBV was concentrated from HepG2DE19 culture supernatants. Information about the virus is shown in Table 2.

[2269] Table 2. Information on HBV Virus Stock

[2270]

[2271]

[2272] *GE = HBV genome equivalent

[2273] reagent

[2274] The main reagents used in the study were QIAamp 96 DNA Blood Kit (QIAGEN #51162), FastStartUniversal Probe Master (Roche #04914058001), CellTiter-Glo (Promega #G7573) and HBsAg ELISA kit (Antu #CL 0310), and Lipofectamine 3...

Embodiment 1

[2324] Example 1. In vitro combination of compounds of formula (V) and (VI)

[2325] Research objectives

[2326] To determine the difference between compounds of formula (V) (GalNAc-conjugated siRNAs targeting the HBV genome and inhibiting production of HBV DNA, HBsAg and HBeAg and HBx) and compounds of formula (VI) (HBV RNA stabilization that inhibits HBV DNA, HBsAg and HBeAg) Whether dual-drug combinations of HBV-infected human primary hepatocytes in cell culture model systems are additive, synergistic, or antagonistic in vitro.

[2327] Results and Conclusions

[2328] Compounds of formula (VI) (concentration ranging from 4.00 μM to 0.05 μM in a 3-fold dilution series and 5-point titration) were combined with compounds of formula (V) (concentrations from 3.0 μg / mL to 0.04 μg / mL in a 3-fold dilution series) range and 5-point titration) combinations were tested on three replicate plates in each of two independent experimental trials. The mean % inhibition of HBV DNA and H...

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Abstract

The invention provides therapeutic combinations and therapeutic methods that are useful for treating Hepatitis B and Hepatitis D.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This patent application claims US Application Serial No. 62 / 821,099, filed March 20, 2019, US Application Serial No. 62 / 825,517, filed March 28, 2019, and US Application Serial No. 62 / , filed September 13, 2019 900,185, which is incorporated herein by reference. Background technique [0003] Hepatitis B virus (abbreviated "HBV") is a member of the hepadnavirus family. Viral particles (sometimes called virions) include an outer lipid envelope and an icosahedral nucleoprotein shell core composed of proteins. The nucleoprotein capsid encapsulates viral DNA and a DNA polymerase with reverse transcriptase activity. The outer envelope contains embedded proteins involved in viral binding and entry into susceptible cells (usually liver hepatocytes). In addition to infectious virus particles, core-deficient filaments and spheroids can also be found in the serum of infected individuals. These particles are not infectious and ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D471/04A61K31/4985A61P31/12
CPCA61P31/12C07D249/08C07D471/14C12N15/1131C12N2310/14C12N2320/31C12N2320/32A61K31/4375A61K31/4196A61K31/683A61K31/675A61K31/522A61K47/549A61K47/60A61K47/6929A61K2300/00A61K47/55A61P31/20A61K31/7088A61K38/212
Inventor 安杰伊·阿尔德齐恩斯基安德烈·库科纳蒂艾米·C·H·李纳格拉杰·玛尼科内利斯·A·赖恩布兰德迈克尔·J·索菲娅埃米莉·P·悌
Owner 阿布特斯生物制药公司
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