# US 10,441,589 B2 · Combinations and methods comprising a capsid assembly inhibitor

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- Number: US 10,441,589 B2
- Document ID: US10441589B2
- Status: Granted
- Kind: B2
- Application number: 15/488,368
- Filed: 2017-04-14
- Published: 2017-11-30
- Granted: 2019-10-15
- Earliest claimed: 2016-04-15
- Assignees: Novira Therapeutics, Inc.; Janssen Sciences Ireland Unlimited Company
- Applicants: Novira Therapeutics, Inc.; Janssen Sciences Ireland Unlimited Company
- Inventors: George Hartman; Osvaldo Flores; Klaus Klumpp; Man Iu Lam; Jan Martin Berke
- Web page: https://patentgrep.com/patent/US10441589B2

## CPC

- A61K 31/52: Purines, e.g. adenine
- A61K 31/03: aromatic
- A61K 31/095: Sulfur, selenium, or tellurium compounds, e.g. thiols
- A61K 31/18: Sulfonamides (compounds containing a para-N-benzene-sulfonyl-N- group A61K31/63)
- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
- A61K 31/7072: having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 31/20: for DNA viruses
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 31/706: containing six-membered rings with nitrogen as a ring hetero atom
- C12N 7/06: {Inactivation or attenuation} by chemical treatment
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present disclosure is directed to capsid assembly inhibitor compositions and methods for use in the treatment of hepatitis B virus infection.

## Claims

### Claim 1

A combination product comprising a therapeutically effective amount of a core protein allosteric modulator (CpAM) and a therapeutically effective amount of reverse transcriptase inhibitor, wherein the core protein allosteric modulator is a core protein allosteric modulator that causes assembly of capsids that are essentially empty with respect to their viral contents, wherein the core protein allosteric modulator is compound 2:
or a pharmaceutically acceptable salt thereof, a hydrate thereof, a solvate thereof, or a crystalline form thereof;
and the reverse transcriptase inhibitor is entecavir.

### Claim 2

A combination product comprising a therapeutically effective amount of a core protein allosteric modulator (CpAM) and a therapeutically effective amount of reverse transcriptase inhibitor, wherein the core protein allosteric modulator is a core protein allosteric modulator that causes assembly of capsids that are essentially empty with respect to their viral contents, wherein the core protein allosteric modulator is compound 2:
or a pharmaceutically acceptable salt thereof, a hydrate thereof, a solvate thereof, or a crystalline form thereof;
and the reverse transcriptase inhibitor is tenofovir.

### Claim 3

A combination product comprising a therapeutically effective amount of a core protein allosteric modulator (CpAM) and a therapeutically effective amount of reverse transcriptase inhibitor, wherein the core protein allosteric modulator is a core protein allosteric modulator that causes assembly of capsids that are essentially empty with respect to their viral contents, wherein the core protein allosteric modulator is compound 3:
or a pharmaceutically acceptable salt thereof, a hydrate thereof, a solvate thereof, or a crystalline form thereof;
and the reverse transcriptase inhibitor is entecavir.

### Claim 4

A combination product comprising a therapeutically effective amount of a core protein allosteric modulator (CpAM) and a therapeutically effective amount of reverse transcriptase inhibitor, wherein the core protein allosteric modulator is a core protein allosteric modulator that causes assembly of capsids that are essentially empty with respect to their viral contents, wherein the core protein allosteric modulator is compound 3:
or a pharmaceutically acceptable salt thereof, a hydrate thereof, a solvate thereof, or a crystalline form thereof;
and the reverse transcriptase inhibitor is tenofovir.