# US 2020/0399388 A1 · Treatment of diabetes mellitus

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- Number: US 2020/0399388 A1
- Document ID: US20200399388A1
- Status: Published application
- Kind: A1
- Application number: 17/007,451
- Filed: 2020-08-31
- Published: 2020-12-24
- Earliest claimed: 2017-08-22
- Inventors: Eyal Levit
- Web page: https://patentgrep.com/patent/US20200399388A1

## CPC

- C07K 16/2887: {against CD20}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/2009: {Inorganic compounds}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- 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

The present invention provides a method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject a therapeutically effective amount of a Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, or a therapeutically effective amount of intravenous immunoglobulin, or a therapeutically effective amount of a therapeutic agent that destroys B lymphocytes, or a combination thereof. The present invention also provides kits containing the same.

## Claims

### Claim 1

A method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject a therapeutically effective amount of a Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, or a therapeutically effective amount of intravenous immunoglobulin, or a therapeutically effective amount of a therapeutic agent that destroys B lymphocytes, or a combination thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, is selected from the group consisting of a JAK1/3 inhibitor and a JAK3 inhibitor.

### Claim 3 (depends on 2)

The method of claim 2, wherein the Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, is tofacitinib.

### Claim 4 (depends on 3)

The method of claim 3, wherein the Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, is tofacitinib citrate.

### Claim 5 (depends on 1)

The method of claim 1, wherein the therapeutic agent that destroys B lymphocytes is an antibody agent.

### Claim 6 (depends on 5)

The method of claim 5, wherein the antibody agent is an anti-CD20 antibody agent.

### Claim 7 (depends on 6)

The method of claim 6, wherein the anti-CD20 antibody agent comprises amino acid sequences substantially identical to the CDRs of rituximab.

### Claim 8 (depends on 4)

The method of claim 4, wherein tofacitinib citrate is administered orally.

### Claim 9 (depends on 8)

The method of claim 8, wherein tofacitinib citrate is administered as a tablet.

### Claim 10 (depends on 9)

The method of claim 9, wherein the tablet is an immediate-release tablet, comprising one or more binders, or one or more diluents, or one or more disintegrants, or one or more lubricants, or combinations thereof.

### Claim 11 (depends on 10)

The method of claim 10, wherein the immediate-release tablet comprises about 8 mg tofacitinib citrate.

### Claim 12 (depends on 9)

The method of claim 9, wherein the tablet is an extended-release tablet, comprising one or more binders, or one or more diluents, or one or more disintegrants, or one or more lubricants, or combinations thereof.

### Claim 13 (depends on 12)

The method of claim 12, wherein the extended-release tablet comprises about 17.77 mg tofacitinib citrate.

### Claim 14 (depends on 1)

The method of claim 1, wherein the intravenous immunoglobulin is administered as a sterile solution for injection comprising from 9%-11% protein in 0.16-0.24 M glycine.

### Claim 15 (depends on 4)

The method of claim 4, wherein tofacitinib citrate is administered at a dose of 8 or 16 mg twice daily.

### Claim 16 (depends on 1)

The method of claim 1, wherein the intravenous immunoglobulin is administered at a dose of 1 to 2 mg per kg weight of the subject every 1 to 3 weeks.

### Claim 17

A kit for the treatment of insulin-dependent diabetes mellitus in a subject, comprising a Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, and intravenous immunoglobulin.

### Claim 18 (depends on 17)

The kit of claim 17, further comprising a therapeutic agent that destroys B lymphocytes.

### Claim 19 (depends on 17)

The kit of claim 17, wherein the Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, is tofacitinib citrate; and wherein the therapeutic agent that destroys B lymphocytes is rituximab.

### Claim 20

A kit for the treatment of insulin-dependent diabetes mellitus in a subject, comprising intravenous immunoglobulin and a therapeutic agent that destroys B lymphocytes.