# US 10,478,474 B2 · Thymosin alpha 1 for use in treatment of cystic fibrosis

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- Number: US 10,478,474 B2
- Document ID: US10478474B2
- Status: Granted
- Kind: B2
- Application number: 15/549,073
- Filed: 2016-02-04
- Published: 2018-02-08
- Granted: 2019-11-19
- Earliest claimed: 2015-09-18
- Assignees: SciClone Pharmaceuticals International Ltd.
- Applicants: SciClone Pharmaceuticals International Ltd.
- Inventors: Luigina Romani; Enrico Garaci
- Web page: https://patentgrep.com/patent/US10478474B2

## CPC

- A61K 38/2292: {Thymosin; Related peptides}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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 concerns Thymosin alpha 1 for use in treatment of cystic fibrosis as a CFTR corrector, CFTR potentiator and anti-inflammatory agent.

## Claims

### Claim 1

A method of treating cystic fibrosis in a patient comprising administering a pharmaceutical composition comprising Thymosin alpha 1 to the patient, wherein the patient has a cystic fibrosis transmembrane conductance regulator (CFTR) mutation ΔF508.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the composition comprises a combination of Thymosin alpha 1 with at least one agent selected from the group consisting of antibiotic, antifungal, Cystic fibrosis transmembrane conductance regulator (CFTR) corrector, and CFTR potentiator agent, wherein said CFTR corrector or potentiator being other than Thymosin alpha 1.

### Claim 3 (depends on 2)

The method according to claim 2, wherein said at least one antibiotic agent is selected from the group consisting of tobramycin, ciprofloxacin, and colistin.

### Claim 4 (depends on 2)

The method according to claim 2, wherein said at least one antifungal agent is selected from the group consisting of itraconazole and amphotericin B.

### Claim 5 (depends on 2)

The method according to claim 2, wherein said at least one CFTR corrector or potentiator agent other than Thymosin alpha 1 is selected from the group consisting of Ivacaftor and Lumacaftor.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition comprises one or more excipients and/or coadjuvants.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the method consists of administering a pharmaceutical composition comprising Thymosin alpha 1 to the patient, wherein Thymosin alpha 1 is the only active principle in the composition.

### Claim 8 (depends on 2)

The method according to claim 2, wherein Thymosin alpha 1 and said at least one agent selected from the group consisting of antibiotic, antifungal, CFTR corrector, and CFTR potentiator agent are administered to the patient together, separately, or sequentially.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the treatment prevents chronic inflammation in patients affected by cystic fibrosis.

### Claim 10

A method of treating cystic fibrosis (CF) in a patient, wherein the patient has a cystic fibrosis transmembrane conductance regulator (CFTR) mutation ΔF508 (ΔF508-CFTR), the method comprises administering a pharmaceutical composition comprising Thymosin alpha 1 to the patient, wherein the treatment is intended to cause one or more effects selected from the group consisting of:
(1) increasing cell surface expression of ΔF508-CFTR in CF cells of the patient;
(2) increasing the functional activity of ΔF508-CFTR in CF cells of the patient; and
(3) inducing the expression of alternative ion channel TMEM16A in the patient.