# US 11,026,978 B2 · Compositions and methods for treating multiple sclerosis and related disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,978 B2 - Document ID: US11026978B2 - Status: Granted - Kind: B2 - Application number: 16/340,751 - Filed: 2017-10-11 - Published: 2020-02-13 - Granted: 2021-06-08 - Earliest claimed: 2016-10-11 - Assignees: Finch Therapeutics Holdings LLC - Applicants: Finch Therapeutics Holdings LLC - Inventors: Thomas Julius Borody - Web page: https://patentgrep.com/patent/US11026978B2 ## CPC - A61K 35/38: Stomach; Intestine; Goblet cells; Oral mucosa; Saliva - A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - 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 disclosure is in the field of pharmaceutical compositions suitable for the treatment of diseases in mammals. The disclosure provides novel compositions comprising non-pathogenic fecal microbes for treating multiple sclerosis and related diseases. The disclosure also provides methods for treating a subject with the compositions disclosed herein. ## Claims ### Claim 1 A method for treating relapsing-remitting multiple sclerosis in a human subject in need thereof, the method comprising administering to the human subject a pharmaceutically active dose of a therapeutic composition comprising a community of fecal bacteria derived from a stool or portion thereof of a healthy human donor, wherein the therapeutic composition further comprises a cultured bacterial isolate. ### Claim 2 (depends on 1) The method of claim 1, wherein the method reduces one or more symptoms selected from the group consisting of: constipation and stool leakage, difficulty urinating, frequent urination, urine leakage, double vision, eye discomfort, rapid eye movements, vision loss, memory loss, difficulty solving problems, depression, hearing loss, slurred speech, difficulty with chewing and difficulty with swallowing, limb weakness, tremors, numbness, and motor difficulties. ### Claim 3 (depends on 1) The method of claim 1, wherein the composition comprises a cryoprotectant. ### Claim 4 (depends on 3) The method of claim 3, wherein the cryoprotectant is selected from the group consisting of polyethylene glycol, skim milk, erythritol, arabitol, sorbitol, glucose, fructose, alanine, glycine, proline, sucrose, lactose, ribose, trehalose, dimethyl sulfoxide (DMSO), glycerol, and a combination thereof. ### Claim 5 (depends on 1) The method of claim 1, wherein the composition is in a liquid, frozen, freeze-dried, spray-dried, foam-dried, or powder form. ### Claim 6 (depends on 1) The method of claim 1, wherein the composition is orally administered. ### Claim 7 (depends on 6) The method of claim 6, wherein the composition is formulated as a delayed or gradual enteric release form. ### Claim 8 (depends on 1) The method of claim 1, wherein the composition is formulated as an enteric-coated capsule or an acid-resistant capsule. ### Claim 9 (depends on 1) The method of claim 1, wherein the subject is pre-treated with an antibiotic prior to administration of the composition. ### Claim 10 A method for treating multiple sclerosis in a human subject in need thereof, the method comprising administering to the human subject (i) a bacterial isolate, and (ii) a preparation of live non-pathogenic fecal bacteria harvested from a healthy human donor. ### Claim 11 (depends on 10) The method of claim 10, wherein the multiple sclerosis is clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), and secondary progressive multiple sclerosis (SPMS). ### Claim 12 (depends on 10) The method of claim 10, wherein the method reduces one or more symptoms selected from the group consisting of: constipation and stool leakage, difficulty urinating, frequent urination, urine leakage, double vision, eye discomfort, rapid eye movements, vision loss, memory loss, difficulty solving problems, depression, hearing loss, slurred speech, difficulty with chewing and difficulty with swallowing, limb weakness, tremors, numbness, and motor difficulties. ### Claim 13 (depends on 10) The method of claim 10, wherein the composition comprises a cryoprotectant. ### Claim 14 (depends on 13) The method of claim 13, wherein the cryoprotectant is selected from the group consisting of polyethylene glycol, skim milk, erythritol, arabitol, sorbitol, glucose, fructose, alanine, glycine, proline, sucrose, lactose, ribose, trehalose, dimethyl sulfoxide (DMSO), glycerol, and a combination thereof. ### Claim 15 (depends on 10) The method of claim 10, wherein the composition is in a liquid, frozen, freeze-dried, spray-dried, foam-dried, or powder form. ### Claim 16 (depends on 10) The method of claim 10, wherein the composition is orally administered. ### Claim 17 (depends on 16) The method of claim 16, wherein the composition is formulated as a delayed or gradual enteric release form. ### Claim 18 (depends on 10) The method of claim 10, wherein the composition is formulated as an enteric-coated capsule or an acid-resistant capsule. ### Claim 19 (depends on 10) The method of claim 10, wherein the subject is pre-treated with an antibiotic prior to administration of the composition. ### Claim 20 (depends on 10) The method of claim 10, wherein the therapeutic composition further comprises a non-cellular fecal filtrate.