# US 2025/0144121 A1 · Compositions and methods for treating multiple sclerosis

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- Number: US 2025/0144121 A1
- Document ID: US20250144121A1
- Status: Published application
- Kind: A1
- Application number: 18/885,310
- Filed: 2024-09-13
- Published: 2025-05-08
- Earliest claimed: 2017-03-17
- Assignees: Vitalis LLC
- Applicants: Vitalis LLC
- Inventors: Joseph Habboushe
- Web page: https://patentgrep.com/patent/US20250144121A1

## CPC

- A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)}
- A61K 9/50: Microcapsules {having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals (A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167)}
- A61K 9/5026: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/5042: {Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose}
- A61K 9/5073: {having two or more different coatings optionally including drug-containing subcoatings}
- A61K 31/194: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
- A61K 31/225: Polycarboxylic acids
- A61P 25/00: Drugs for disorders of the nervous system
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- 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

Provided are compositions and methods for treating multiple sclerosis (MS). One embodiment of the disclosed method entails orally administering to a MS patient a first amount of aspirin and a second amount of fumaric acid or an ester or a salt thereof. In some embodiments, the aspirin is administered at from about 80 mg to about 500 mg per day and the fumaric acid or ester or salt thereof is administered at about 360 mg per day.

## Claims

### Claim at position 1

1-11. (canceled)

### Claim 12

A capsule comprising a dosage form comprising an effective amount of aspirin and an effective amount a fumaric acid or an ester or a salt thereof, wherein the aspirin and fumaric acid or an ester or a salt thereof are each individually formulated as enterically coated microspheres contained within a capsule shell.

### Claim 13 (depends on 12)

The capsule of claim 12, wherein the capsule is coated with a second dose of aspirin formulated to dissolve in an oral cavity of a subject.

### Claim 14 (depends on 13)

The capsule of claim 13, comprising from about 20 mg to about 500 mg of aspirin.

### Claim 15

A method of treating multiple sclerosis (MS) in a human patient in need thereof, comprising orally administering to the patient a dosage form comprising aspirin and fumaric acid or an ester or a salt thereof, wherein the aspirin is administered at from about 150 mg to about 650 mg per day and the fumaric acid or ester or salt thereof is administered at about 300 mg to about 450 mg per day.

### Claim 16 (depends on 15)

The method of claim 15, wherein at least a portion of the aspirin is formulated to dissolve in an oral cavity of a subject.

### Claim 17 (depends on 15)

The method of claim 15, wherein the fumaric acid or ester or salt thereof is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject.

### Claim 18 (depends on 15)

The method of claim 15, wherein the pharmaceutical composition is in the form of a capsule.

### Claim 19

A method of treating multiple sclerosis (MS), psoriasis, a motor neuron disease, a neurodegenerative disease, an autoimmune disease, an inflammatory disease, sepsis, or a skin disease in a human patient in need thereof, comprising orally administering to the patient one or more tablets each comprising a first portion comprising a first amount of aspirin and a second portion comprising a second amount of fumaric acid or an ester or a salt thereof,
wherein the first portion is formulated to dissolve in an oral cavity of a subject,
wherein the second portion is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject, and
wherein the aspirin is administered at from about 150 mg to about 650 mg per day and the fumaric acid or ester or salt thereof is administered at about 300 mg to about 450 mg per day.

### Claim 20 (depends on 19)

The method of claim 19, wherein the patient suffers from relapse-remitting MS (RRMS).

### Claim 21 (depends on 19)

The method of claim 19, wherein the patient has a history of non-compliance with a medication due to cutaneous flush or a gastrointestinal side effect.

### Claim 22 (depends on 19)

The method of claim 19, wherein the second amount of the fumaric acid or ester or salt thereof is about 180 mg.

### Claim 23 (depends on 22)

The method of claim 22, wherein the first amount of aspirin is from about 80 mg to about 250 mg.

### Claim 24 (depends on 22)

The method of claim 22, wherein the second portion further comprises a third amount of aspirin.

### Claim 25 (depends on 24)

The method of claim 24, wherein the first amount of aspirin and the second amount of aspirin each is from about 20 mg to about 120 mg or from about 80 mg to about 120 mg.

### Claim 26 (depends on 22)

The method of claim 22, wherein the second portion is enclosed in an enteric coating.

### Claim 27 (depends on 19)

The method of claim 19, wherein the ester is dimethyl fumarate, monomethyl fumarate or combination thereof.

### Claim at position 18

28-48. (canceled)