PHARMACEUTICAL COMPOSITIONS COMPRISING DGLA AND USE OF SAME

• US 20170196825A1
• Filed: 01/06/2017
• Published: 07/13/2017
• Est. Priority Date: 01/07/2016
• Status: Abandoned Application

• Current Assignee: DS Biopharma Limited
• Original Assignee: Dignity Sciences Limited
• Inventors: Manku, Mehar, Climax, John, Coughlan, David, Dunne, James
• Application Number:
  US15/400,132
• Publication Number:
  US 20170196825A1
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: G01N 33/5005 involving human or animal cells immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025

Abstract

The present disclosure provides orally deliverable pharmaceutical compositions comprising DGLA and methods of using same to treat a variety of conditions and disorders.

Claims

1. A method of treating a skin disease or disorder in a subject in need thereof, the method comprising orally administering to the subject a pharmaceutical composition comprising DGLA or a derivative thereof.

2. The method of claim 1, wherein the composition is administered to the subject in an amount sufficient to provide about 1 g to about 4 g of DGLA or a derivative thereof per day.

3. The method of claim 1, wherein the DGLA or derivative thereof is administered to the subject for a period of at least about 2 weeks, at least about 4 weeks or at least about 8 weeks.

4. The method of claim 1, wherein the subject is a pediatric subject.

5. The method of claim 1, wherein the subject has a low eosinophil cell count.

6. The method of claim 5, wherein the low eosinophil cell count is determined based on a reference level.

7. A method of reducing at least one of an investigator global assessment level, eczema area and severity index (EASI) score, a percentage of area of an anatomical site affected by atopic dermatitis, Scoring atopic dermatitis (SCORAD), a body surface area affected by atopic dermatitis, or Visual Analog Scale (VAS) pruritus score in a subject in need thereof, the method comprising orally administering to the subject up to 4 g per day of DGLA or derivative thereof.

8. The method of claim 7, wherein about 0.2 to about 3 g of DGLA or derivative thereof is orally administered to the subject per day.

9. The method of claim 7, wherein about 0.5 g, about 1 g or about 2 g of DGLA or derivative thereof is orally administered to the subject per day.

10. The method of claim 7, wherein less than 1 g of DGLA or derivative thereof is orally administered to the subject per day.

11. The method of claim 7, wherein the subject is a pediatric subject.

12. The method of claim 7, wherein the DGLA or derivative thereof is administered to the subject for a period of at least about 2 weeks, at least about 4 weeks or at least about 8 weeks.

13. The method of claim 7, wherein the pharmaceutical composition comprises DGLA or a derivative thereof in a liquid or semi-liquid format.

14. The method of claim 7, wherein the subject is determined to have a low baseline eosinophil count as compared to a reference level.