IP Library › Granted Patent US 12,245,998
Granted Patent B2
US 12,245,998 · App. 17/421,318 · Granted Mar 11, 2025

N-acetylcysteine amide (NACA) and (2R,2R′)-3,3′ disulfanediyl bis(2-acetamidopropanamide) (diNACA) for the prevention and treatment of radiation pneumonitis and treatment of pulmonary function in Cystic Fibrosis

Inventor: G. Michael Wall (Fort Worth, TX)
Assignee: Nacuity Pharmaceuticals, Inc.
A61K31/16A61K45/06A61P11/12
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Quick Facts
Patent No.
US 12,245,998
App. No.
17/421,318
Granted
Mar 11, 2025
Kind
B2
Abstract

The present invention includes a method for the use of N-acetylcysteine amide (NACA) or (2R,2R′)-3,3′-disulfanediyl bis(2-acetamidopropanamide) (diNACA) for prevention and treatment of radiation pneumonitis and treatment of pulmonary function in Cystic Fibrosis (CF), chronic obstructive pulmonary disease (COPD), or bronchitis in a human that comprises administering to the human a therapeutically effective amount of NACA or diNACA sufficient to treat, reduce the symptoms, or prevent radiation pneumonitis and treatment of pulmonary function in Cystic Fibrosis (CF), chronic obstructive pulmonary disease (COPD), bronchitis, or respiratory disorder due to oxidative stress, and diNACA for the reduction of mucus viscosity and/or elasticity.

Claims (18)

1. A method for treating Cystic Fibrosis (CF), or bronchitis, in a subject that comprises:

identifying a patient in need of for treatment of Cystic Fibrosis (CF), or bronchitis, by reduction of mucus viscosity and/or elasticity; and

administering to the patient a therapeutically effective amount of N-acetyl cystine amine (NACA) or (2R,2R′)-3,3′-disulfanediyl bis(2-acetamidopropanamide (diNACA).

2. The method of claim 1 , wherein the NACA or diNACA is provided in or with a pharmaceutically acceptable carrier.

3. The method of claim 1 , wherein the NACA or diNACA is administered orally, intravenously, intramuscularly, enterally, intraocularly, subretinally, intravitreally, topically, ocularly, sublingually, by inhalation or rectally.

4. The method of claim 1 , wherein the NACA or diNACA is administered in daily doses of about 0.5 to 150 mg/Kg.

5. The method of claim 1 , wherein the NACA or diNACA is administered two or three times daily.

6. The method of claim 1 , wherein the NACA or diNACA is administered with a second active agent.

7. The method of claim 1 , wherein the NACA or diNACA is administered with a second active agent selected from at least one of ascorbic acid, cysteine hydrochloride, sodium bisulfate, sodium metabisulfite, sodium sulfite, ascorbyl palmitate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), lecithin, propyl gallate, α-tocopherol, citric acid, ethylenediamine tetraacetic acid (EDTA), sorbitol, tartaric acid, or phosphoric acid.

8. The method of claim 1 , wherein the dose for administration is 100, 150, 300, 333, 400, 500, 600, 700, 750, 800, 900, 1,000, 2,500, 5,000, 7,500, or 10,000 mg per dose.

9. The method of claim 1 , wherein the NACA or diNACA is delivered orally via a mini-tablet, capsule, tablet, effervescent, dual release, mixed release, sachet, powder, aerosol, spray, or liquid.

10. The method of claim 1 , wherein the NACA or diNACA is administered prophylactically for prevention and treatment of Cystic Fibrosis (CF), chronic obstructive pulmonary disease (COPD), or bronchitis, or respiratory disorder due to oxidative stress.

11. The method of claim 1 , wherein the therapeutically effective amount decreases at least one of the loss of night vision, the loss of overall visual acuity, the loss of visual field, by at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or more as compared to an untreated control subject over a defined period of time, selected from at least one of 2 weeks, one month, 2 months, 3 months, 6 months, one year, 2 years, or 5 years.

12. The method of claim 1 , wherein the NACA or diNACA is delivered orally via a mini-tablet, capsule, tablet, effervescent, dual release, mixed release, sachet, powder, or liquid.

13. The method of claim 1 , wherein the therapeutically effective amount decreases the loss of overall visual acuity, the loss of visual field, by at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or more as compared to an untreated control subject over a defined period of time, selected from at least one of 2 weeks, one month, 2 months, 3 months, 6 months, one year, 2 years, or 5 years.

14. The methods of claim 1 , wherein diNACA reduces at least one of: mucus viscosity, elasticity, or cohesion.

15. A method for treatment of chronic obstructive pulmonary disease (COPD), or bronchitis comprising:

administering to the human patient a therapeutically effective amount of diNACA sufficient to treat, chronic obstructive pulmonary disease (COPD), or bronchitis.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 3, 2021
From: WALL, G. MICHAEL
To: NACUITY PHARMACEUTICALS, INC.
Reel/Frame 057381/0460 →
Continuity (2)
Provisional Application 62791442 · Jan 11, 2019
Related Publication 20220062203A1 · Mar 3, 2022
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