IP Library Granted Patent US 11,364,287
Granted Patent B2
US 11,364,287 · App. 16/422,462 · Granted Jun 21, 2022

Methods of treating celiac disease

Inventors: Joan M. Fallon (White Plains, NY); Matthew F. Heil (Sherman, CT); James Szigethy (Montgomery, NY); James J. Fallon (Armonk, NY)
Assignee: CUREMARK, LLC
A61K38/54A61K38/465A61K38/47A61K38/48
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Quick Facts
Patent No.
US 11,364,287
App. No.
16/422,462
Granted
Jun 21, 2022
Kind
B2
Abstract

Described herein are compositions which include digestive enzymes and which are formulated to reduce one or more symptoms of Celiac Disease. Also described herein is a method for treating a subject with Celiac Disease using digestive enzymes and their derivatives to alleviate the symptoms of Celiac Disease. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally or recombinantly derived, or their derivatives, in an amount effective to reduce one or more symptoms of Celiac Disease.

Claims (11)

1. A method for treating Celiac disease in subject in need thereof who is not on a gluten-free diet, comprising administering to the subject a therapeutically effective amount of a composition that comprises digestive enzymes, wherein the digestive enzymes comprise a protease, an amylase, and a lipase, and wherein the Celiac disease is treated.

2. The method of claim 1 , wherein the composition is administered until one or more symptoms of Celiac disease are partially or completely resolved.

3. The method of claim 2 , wherein the one or more symptoms are selected from the group consisting of abdominal pain, bloating, gas, indigestion, constipation, decreased appetite, diarrhea, lactose intolerance, nausea, vomiting, unexplained weight loss, bruising easily, depression, anxiety, chronic headaches, migraines, fatigue, growth delay in children, hair loss, itchy skin, missed menstrual periods, mouth ulcers, muscle cramps, joint pain, nosebleeds, seizures, tingling in the hands, tingling in the feet, numbness in the hands, numbness in the feet, unexplained short height, defects in the tooth enamel, changes in tooth color, delayed puberty, irritable behavior, fussy behavior, poor weight gain, slowed growth, shorter than normal height, an abnormal stool, osteoporosis, a vitamin deficiency, a mineral deficiency, malaise, an iron deficiency anemia, pancreatic cancer, lymphoma, gastric cancer, colon cancer, intestinal cancer, dementia, and a combination thereof.

4. The method of claim 1 , wherein the composition comprises the protease, and the protease comprises chymotrypsin, trypsin, papain, or a combination thereof.

5. The method of claim 1 , wherein the digestive enzymes are animal enzymes, plant enzymes, synthetic enzymes, or a combination thereof.

6. The method of claim 1 , wherein the composition is administered to the subject orally.

7. The method of claim 1 , wherein a total amount of the protease in the composition is from about 10,000 to about 1,500,000; from about 25,000 to about 1,000,000; from about 50,000 to about 750,000; from about 75,000 to about 500,000; from about 85,000 to about 250,000; from about 95,000 to about 200,000; or from about 110,000 to about 150,000 U.S.P. units/dose.

8. The method of claim 1 , wherein a total amount of the amylase in the composition is from about 1,000 to about 15,000,000; from about 5,000 to about 1,000,000; from about 15,000 to about 750,000; from about 50,000 to about 500,000; from about 75,000 to about 250,000; from about 95,000 to about 200,000; or from about 100,000 to about 150,000 U.S.P. units/dose.

9. The method of claim 1 , wherein a total amount of the lipase in the composition is from about 1,500 to about 282,000; from about 5,000 to about 200,000; from about 5,000 to about 150,000; from about 75,000 to about 100,000; from about 10,000 to about 75,000; from about 15,000 to about 50,000; or from about 20,000 to about 40,000 U.S.P. units/dose.

10. The method of claim 1 , wherein the treatment increases weight gain of the subject.

11. The method of claim 1 , wherein the digestive enzymes are provided as pancreatin.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 12, 2019
From: FALLON, JOAN M.; HEIL, MATTHEW F.; SZIGETHY, JAMES; FALLON, JAMES J.
To: CUREMARK, LLC
Reel/Frame 049736/0580 →
Continuity (3)
Continuation 13866135 · Mar 15, 2013
Provisional Application 61653253 · May 30, 2012
Related Publication 20190275123A1 · Sep 12, 2019
Cited By (1)
US 12,485,094