# US 2021/0330710 A1 · Inflammatory cytokine production inhibitor

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- Number: US 2021/0330710 A1
- Document ID: US20210330710A1
- Status: Published application
- Kind: A1
- Application number: 17/273,917
- Filed: 2019-09-04
- Published: 2021-10-28
- Earliest claimed: 2018-09-05
- Assignees: Saisei Pharma Co., Ltd.
- Applicants: Saisei Pharma Co., Ltd.
- Inventors: Toshio Inui
- Web page: https://patentgrep.com/patent/US20210330710A1

## CPC

- A61K 35/20: Milk; Whey; Colostrum
- C12N 9/2471: {Beta-galactosidase (3.2.1.23), i.e. exo-(1-->4)-beta-D-galactanase}
- A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21)
- A23L 33/19: Dairy proteins
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 38/018: {from milk}
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 17/00: Drugs for dermatological disorders
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/24: Antidepressants
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12Y 302/01023: Beta-galactosidase (3.2.1.23), i.e. exo-(1-->4)-beta-D-galactanase
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Y: ENZYMES

## Abstract

Provided are inflammatory cytokine production inhibitors which inhibit the production of the inflammatory cytokines TNF-α and IL-1β and can be applied to drugs effective against inflammatory diseases caused by overproduction of these inflammatory cytokines, such as chronic inflammation (e.g., rheumatoid arthritis, ulcerative colitis) and Crohn's disease, as well as type 2 diabetes, depression, obesity, sepsis, atherosclerosis, dermatitis, dementia, schizophrenia, and Parkinson's disease, and also to foods and drinks such as health foods. The inflammatory cytokine production inhibitors contain as an active ingredient an enzyme-treated whey obtained by contacting whey with β-galactosidase. The enzyme-treated whey is obtained by further contacting with sialidase.

## Claims

### Claim 1

An inflammatory cytokine production inhibitor, comprising as an active ingredient an enzyme-treated whey obtained by contacting whey with β-galactosidase.

### Claim 2 (depends on 1)

The inflammatory cytokine production inhibitor according to claim 1, wherein the enzyme-treated whey is obtained by further contacting with sialidase.

### Claim 3 (depends on 1)

The inflammatory cytokine production inhibitor according to claim 1, wherein the inflammatory cytokine is interleukin-1β (IL-1β), interleukin-6 (IL-6), or tumor necrosis factor (TNF-α).

### Claim 4 (depends on 1)

The inflammatory cytokine production inhibitor according to claim 1, wherein the enzyme-treated whey contains 0.02 μg to 40 mg/kg/dose of proteins.

### Claim 5 (depends on 1)

A drug or a food or drink, comprising the inflammatory cytokine production inhibitor according to claim 1.

### Claim 6 (depends on 5)

The drug or the food or drink according to claim 5, wherein the drug or the food or drink is in an orally administrable or orally ingestible form.

### Claim 7

A method for preparing an enzyme-treated whey having an effect of inhibiting inflammatory cytokine production, the method comprising contacting whey with β-galactosidase to cleave a β-1,6-glycosidic bond of a protein in the whey.

### Claim 8 (depends on 7)

The method according to claim 7, wherein the β-galactosidase is derived from Escherichia coli or bovine liver.

### Claim 9 (depends on 7)

The method for preparing an enzyme-treated whey having an effect of inhibiting inflammatory cytokine production according to claim 7, comprising further contacting with sialidase.