# US 11,078,516 B2 · Inhibition and treatment of gastrointestinal biofilms

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- Number: US 11,078,516 B2
- Document ID: US11078516B2
- Status: Granted
- Kind: B2
- Application number: 15/979,362
- Filed: 2018-05-14
- Published: 2018-09-13
- Granted: 2021-08-03
- Earliest claimed: 2008-02-08
- Assignees: Prothera, Inc.
- Applicants: Prothera, Inc.
- Inventors: Stephen Francis Olmstead
- Web page: https://patentgrep.com/patent/US11078516B2

## CPC

- C12Q 1/18: Testing for antimicrobial activity of a material
- A61K 31/70: Carbohydrates; Sugars; Derivatives thereof (sorbitol A61K31/047)
- A61K 38/465: {acting on ester bonds (3.1), e.g. lipases, ribonucleases}
- A61K 38/47: acting on glycosyl compounds (3.2), e.g. cellulases, lactases
- A61K 38/48: acting on peptide bonds (3.4)
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- G01N 2333/914: Hydrolases (3)
- G01N 2500/04: Screening involving studying the effect of compounds C directly on molecule A (e.g. C are potential ligands for a receptor A, or potential substrates for an enzyme A)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Orally administered physiologically acceptable anti-biofilm compositions comprising enzymes and if desired additional components such as antimicrobials, antibiotics, antifungals, herbals, chelating agents, lactoferrin and related compounds, minerals, surfactants, binders, and fillers useful for the inhibition and treatment of gastrointestinal biofilms in humans. Physiologically acceptable anti-biofilm compositions containing these enzymes are useful in the inhibition, reduction and/or treatment of gastrointestinal biofilm infections, and associated systemic symptoms caused by biofilms associated microorganisms within the gastrointestinal tract. Methods of identification, preparation and use of such physiologically acceptable anti-biofilm compositions are also provided.

## Claims

### Claim 1

A method of inhibiting a gastrointestinal biofilm infection in a mammal, the method comprising:
identifying the presence of the gastrointestinal biofilm infection; and
orally administering to the mammal a therapeutically effective amount of a composition comprising:
a multi-enzyme mixture comprising: cellulase; glucoamylase;
hemicellulase/pectinase complex; beta-glucanase; an enzyme with dipeptidyl-peptidase IV (DPP-IV) activity; chitosanase; lysozyme; a Serratia peptidase; a chelating agent; and at least one pharmaceutically acceptable carrier,
in an amount and for a time sufficient to cause significant biofilm degradation within the gastrointestinal system of the mammal.

### Claim 2 (depends on 1)

The The method of claim 1, wherein the chelating agent is ethylenediaminetetraaceticacid (EDTA).

### Claim 3 (depends on 1)

The method of claim 1, wherein the amount of cellulase per dose ranges from 1 to 10,000 CU, the amount of hemicellulase/pectinase complex ranges from 1 to 8,000 HSU, and the amount of beta-glucanase ranges from 1 to 1000 BGU.