# US 10,946,071 B2 · Combination of ibudilast and interferon-beta and methods of using same

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- Number: US 10,946,071 B2
- Document ID: US10946071B2
- Status: Granted
- Kind: B2
- Application number: 16/596,278
- Filed: 2019-10-08
- Published: 2020-04-09
- Granted: 2021-03-16
- Earliest claimed: 2018-10-09
- Assignees: MediciNova, Inc.
- Applicants: MediciNova, Inc.
- Inventors: Kazuko Matsuda
- Web page: https://patentgrep.com/patent/US10946071B2

## CPC

- A61K 38/215: {IFN-beta}
- A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
- 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
- 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

This disclosure is directed to methods of alleviating the negative effects of, treating, or slowing the progression of progressive multiple sclerosis in human patients using ibudilast and interferon-beta.

## Claims

### Claim 1

A method of (i) alleviating the negative effects of a progressive multiple sclerosis in a human patient in need thereof, (ii) treating a progressive multiple sclerosis in a human patient in need thereof, or (iii) slowing the progression of a progressive multiple sclerosis in a human patient in need thereof, the method comprising administering to the human patient:
(a) a therapeutically effective amount of ibudilast or a pharmaceutically acceptable salt thereof, and
(b) a therapeutically effective amount of interferon-beta;
wherein the ibudilast, or pharmaceutically acceptable salt thereof, and the interferon-beta are administered in separate dosage forms.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ibudilast, or pharmaceutically acceptable salt thereof, and the interferon-beta are administered for at least about 12 weeks.

### Claim 3 (depends on 1)

The method of claim 1, wherein prior to the method, the human patient was administered interferon-beta prior to the administration of the ibudilast, or pharmaceutically acceptable salt thereof, and the interferon-beta.

### Claim 4 (depends on 1)

The method of claim 1, wherein the administration of the ibudilast, or pharmaceutically acceptable salt thereof, and the interferon-beta provides a synergistic effect.

### Claim 5 (depends on 4)

The method of claim 4, wherein the synergistic effect is an unexpectedly lower hazard ratio when comparing the effect of the ibudilast-interferon-beta combination versus ibudilast alone.

### Claim 6 (depends on 1)

The method of claim 1, wherein the interferon-beta is administered parenterally.

### Claim 7 (depends on 1)

The method of claim 1, wherein the ibudilast or pharmaceutically acceptable salt thereof is administered in an amount of from about 0.1 mg/day to about 720 mg/day.

### Claim 8 (depends on 7)

The method of claim 7, wherein the amount of ibudilast or pharmaceutically acceptable salt administered per day is divided into two or three portions.

### Claim 9 (depends on 1)

The method of claim 1, wherein the interferon-beta is interferon-beta-1a.

### Claim 10 (depends on 9)

The method of claim 9, wherein the interferon-beta-1a is administered in an amount of from about 0.1 mcg/week to about 500 mcg/week.

### Claim 11 (depends on 10)

The method of claim 10, wherein the amount of interferon-beta-1a administered per week is divided into two, three, four, or five portions.

### Claim 12 (depends on 1)

The method of claim 1, wherein the interferon-beta is interferon-beta-1b.

### Claim 13 (depends on 12)

The method of claim 12, wherein the interferon-beta-1b is administered in an amount of from about 0.01 mg to about 1 mg.

### Claim 14 (depends on 13)

The method of claim 13, wherein the amount of interferon-beta-1b administered is divided into two or three portions.

### Claim 15 (depends on 1)

The method of claim 1, wherein the progressive multiple sclerosis is primary progressive multiple sclerosis.

### Claim 16 (depends on 1)

The method of claim 1, wherein the progressive multiple sclerosis is secondary progressive multiple sclerosis.

### Claim 17 (depends on 1)

The method of claim 1, wherein the human patient is not concurrently administered glatiramer acetate.