# US 11,298,346 B2 · Methods for treatment of fibrotic diseases

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- Number: US 11,298,346 B2
- Document ID: US11298346B2
- Status: Granted
- Kind: B2
- Application number: 15/995,917
- Filed: 2018-06-01
- Published: 2018-12-06
- Granted: 2022-04-12
- Earliest claimed: 2017-06-02
- Applicants: Beta Cat Pharmaceuticals, Inc.
- Inventors: Ruolan Han; Jon Northrup; Srinivas Kasibhatla; Stephen Horrigan; Jeffrey Larson
- Web page: https://patentgrep.com/patent/US11298346B2

## CPC

- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- A61K 9/10: Dispersions; Emulsions
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/00: Drugs for skeletal disorders
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61K 9/0043: {Nose}
- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- 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

## Abstract

Methods for treatment of fibrotic diseases using compounds of formula I wherein RA is hydrogen, R7 and R8 are independently selected from H and SO2NR3R4, one of R7 and R8 is hydrogen, and R1, R2, R3, and R4 are each independently selected from H, alkyl, heteroalkyl, cycloalkyl, arylcycloalkyl, aryl, heteroaryl, heterocycloalkyl, and each of NR1R2 and NR3R4 can independently combine to form a heterocycloalkyl, and wherein said alkyl, heteroalkyl, cycloalkyl, arylcycloalkyl, aryl, heteroaryl, or heterocycloalkyl may be optionally substituted, or a pharmaceutically acceptable salt, ester, amide, stereoisomer, geometric isomer or prodrug thereof.

## Claims

### Claim 1

A method of treating pulmonary fibrosis in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a compound of formula:
or a pharmaceutically acceptable salt thereof, wherein said method prevents beta-catenin from association with trans-ducin-beta-like 1 (TBL1) protein in the patient, wherein the therapeutically effective dose is from about 0.0001 to about 1000 mg/kg/day.

### Claim 2 (depends on 1)

The method of claim 1, wherein said administering is done through one or more of intravenous, parenteral, oral, inhalation (including aerosolized delivery), buccal, intranasal, rectal, intra-lesional intraperitoneal, intradermal, transdermal, subcutaneous, intra-arterial, intracardiac, intraventricular, intracranial, intratracheal, intrathecal administration, intramuscular injection, intravitreous injection, and topical application methods.

### Claim 3 (depends on 1)

The method of claim 1 wherein said administering is done through aerosolized delivery.

### Claim 4 (depends on 1)

The method of claim 1 wherein said administering is done through intratracheal delivery.

### Claim 5 (depends on 3)

The method of claim 3, wherein said compound is formulated in a solution comprising a poloxamer and sorbitol.

### Claim 6 (depends on 3)

The method of claim 3, wherein said compound is formulated in a nano-milled suspension.