# US 11,998,556 B2 · Methods of treating parkinson's disease and/or lewy body disease or disorder(s)

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- Number: US 11,998,556 B2
- Document ID: US11998556B2
- Status: Granted
- Kind: B2
- Application number: 17/814,149
- Filed: 2022-07-21
- Published: 2023-03-02
- Granted: 2024-06-04
- Earliest claimed: 2021-07-23
- Assignees: Athira Pharma, Inc.
- Applicants: Athira Pharma, Inc.
- Inventors: Hans J. Moebius; Xue Hua; Kevin Church; William Walker; Leen H. Kawas
- Web page: https://patentgrep.com/patent/US11998556B2

## CPC

- A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos}
- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 31/66: Phosphorus compounds
- A61K 38/05: Dipeptides
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/16: Anti-Parkinson drugs
- 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 disclosure relates to a method of treating Parkinson's Disease and/or Lewy body disease or disorder(s), including Parkinson's disease dementia and dementia with Lewy bodies, comprising administering to a subject ATH-1017.

## Claims

### Claim 1

A method of treating Parkinson's disease (PD) and/or Lewy body disease or disorder(s) (LBD), comprising administering to a patient in need thereof 40 or 70 mg per day of a compound of formula A19
or a pharmaceutically acceptable salt thereof for 26 weeks or more; wherein the patient is acetylcholinesterase inhibitor (AChEI) naive or received an AChEI in the past and discontinued AChEI therapy at least 4 weeks prior to administration of the compound.

### Claim 2 (depends on 1)

The method of claim 1, wherein the treating comprises improving one or more symptoms of a motor disorder.

### Claim 3 (depends on 1)

The method of claim 1, wherein the patient has been diagnosed with Parkinson's disease dementia (PDD).

### Claim 4 (depends on 1)

The method of claim 1, wherein the patient has been diagnosed with Lewy body disease or disorder(s) (LBD).

### Claim 5 (depends on 1)

The method of claim 1, wherein the patient is between age 40 and 85.

### Claim 6 (depends on 1)

The method of claim 1, wherein the patient is at Hoehn-Yahr stage 1 to 4.

### Claim 7 (depends on 1)

The method of claim 1, wherein the compound of formula A19 or the pharmaceutically acceptable salt thereof is administered by subcutaneous injection.

### Claim 8 (depends on 1)

The method of claim 1, which slows the decline in the ability to perform activities of daily living and verbal fluency in the patient or improves the ability to perform activities of daily living and verbal fluency in the patient.

### Claim 9 (depends on 1)

The method of claim 1, which reduces the rate of decline, stabilizes, or improves a 13-item Alzheimer's Disease Assessment Scale—cognitive subscale (ADAS-Cog13) score.

### Claim 10 (depends on 1)

The method of claim 1, which reduces the rate of decline, stabilizes, or improves a Clinician Global Impression of Change (CGI-C) score or a Clinician Global Impression of Severity (CGI-S) score.

### Claim 11 (depends on 1)

The method of claim 1, which reduces the rate of decline, stabilizes, or improves an Alzheimer's disease cooperative study-activities of daily living, 23-item version (ADCS-ADL23) score.

### Claim 12 (depends on 1)

The method of claim 1, which reduces the rate of decline, stabilizes, or improves a Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score.

### Claim 13 (depends on 1)

The method of claim 1, which reduces the rate of decline, stabilizes, or improves a Non-Motor Symptom Scale (NMSS) score.

### Claim 14 (depends on 13)

The method of claim 13, which reduces the rate of decline, stabilizes, or improves a NMSS domain 2 and/or domain 4 score.

### Claim 15 (depends on 1)

The method of claim 1, which reduces the rate of decline, stabilizes, or improves a Mini-Mental State Examination (MMSE) score.

### Claim 16 (depends on 1)

The method of claim 1, which reduces the rate of decline, stabilizes, or improves a motor symptom in the patient.

### Claim 17 (depends on 16)

The method of claim 16, wherein the reduction in the rate of decline, stabilization, or improvement occurs by at least 2 weeks, at least 4 weeks, at least 6 weeks, at least 8 weeks, at least 10 weeks, at least 12 weeks, at least 16 weeks, at least 18 weeks, at least 20 weeks, at least 22 weeks, at least 24 weeks, or at least 26 weeks after the start of treatment.

### Claim 18 (depends on 1)

The method of claim 1, comprising administering a monosodium salt of the compound of formula A19.

### Claim 19 (depends on 1)

The method of claim 1, comprising administering to the patient in need thereof 40 mg per day of the compound of formula A19, or a pharmaceutically acceptable salt thereof.

### Claim 20 (depends on 7)

The method of claim 7, comprising administering to the patient in need thereof 40 mg per day of the compound of formula A19, or a pharmaceutically acceptable salt thereof.

### Claim 21 (depends on 9)

The method of claim 9, comprising administering to the patient in need thereof 40 mg per day of the compound of formula A19, or a pharmaceutically acceptable salt thereof.

### Claim 22 (depends on 1)

The method of claim 1, wherein the patient has been diagnosed with probable idiopathic Parkinson's disease, or probable LBD.