# US 11,433,102 B2 · Compositions and methods for treating Parkinson's disease (PD) 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 11,433,102 B2 - Document ID: US11433102B2 - Status: Granted - Kind: B2 - Application number: 16/603,036 - Filed: 2018-04-04 - Published: 2020-06-18 - Granted: 2022-09-06 - Earliest claimed: 2017-04-05 - Assignees: Finch Therapeutics Holdings LLC - Applicants: Finch Therapeutics Holdings LLC - Inventors: Thomas J. Borody - Web page: https://patentgrep.com/patent/US11433102B2 ## CPC - A61K 35/38: Stomach; Intestine; Goblet cells; Oral mucosa; Saliva - A61P 25/16: Anti-Parkinson drugs - 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 or a sterile fecal filtrate for treating Parkinson's disease and related diseases. The disclosure also provides methods for treating a subject with the compositions disclosed herein. ## Claims ### Claim 1 A method for treating Parkinson's disease (PD) in a human subject in need thereof, the method comprising orally administering to the human subject one or more compositions comprising (i) a pharmaceutically active induction dose of a therapeutic composition comprising a fecal bacterial preparation comprising a community of live non-pathogenic fecal bacteria from a stool or portion thereof of a healthy human donor, and (ii) a second active agent, wherein the subject is further administered a maintenance dose of the therapeutic composition, wherein the maintenance dose is lower than the induction dose, wherein at least two doses of the therapeutic composition are administered to the subject over a two-week period, and wherein the human subject experiences an improvement in at least one symptom selected from the group consisting of tremor, slowed movement, rigid muscles, impaired posture and balance, loss of automatic movements, speech changes, and writing changes within 15 weeks after initiating treatment. ### Claim 2 (depends on 1) The method of claim 1, wherein the subject has PD at a clinical stage selected from the group consisting of Stages I to V. ### Claim 3 (depends on 1) The method of claim 1, wherein the therapeutic composition comprises a non-selected fecal microbiota. ### Claim 4 (depends on 3) The method of claim 3, wherein the fecal microbiota comprises a donor's substantially entire fecal microbiota. ### Claim 5 (depends on 1) The method of claim 1, wherein the fecal bacteria are from synthetic fecal material. ### Claim 6 (depends on 1) The method of claim 1, wherein the method reduces the rate of progression of one or more of the at least one symptom in the subject. ### Claim 7 (depends on 1) The method of claim 1, wherein the therapeutic composition is administered at least twice weekly for at least three weeks. ### Claim 8 (depends on 1) The method of claim 1, wherein the therapeutic composition is administered at least twice weekly for at least 4 weeks. ### Claim 9 (depends on 1) The method of claim 1, wherein the therapeutic composition is formulated as a delayed or gradual enteric release form. ### Claim 10 (depends on 1) The method of claim 1, wherein the therapeutic composition is in a liquid, frozen, freeze-dried, spray-dried, foam-dried, or powder form. ### Claim 11 (depends on 1) The method of claim 1, wherein the therapeutic composition comprises a cryoprotectant 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 12 (depends on 1) The method of claim 1, wherein the subject is pretreated with an antibiotic prior to administration of the therapeutic composition. ### Claim 13 (depends on 1) The method of claim 1, wherein the second active agent comprises a non-fecal microbiome based therapy. ### Claim 14 (depends on 1) The method of claim 1, wherein the second active agent is selected from the group consisting of bromocriptine, benztropine, levodopa, ropinirole, pramipexole, rotigotine, cabergoline, entacapone, tolcapone, amantadine, and selegiline. ### Claim 15 (depends on 1) The method of claim 1, wherein the second active agent comprises levodopa, a dopamine agonist, an inhibitor of enzymes that inactivate dopamine, a monoamine oxidase B (MAO B) inhibitor, a catechol-O-methyl transferase (COMT) inhibitor, an anticholinergic, amantadine, or estrogen. ### Claim 16 (depends on 1) The method of claim 1, wherein the second active agent is a dopamine agonist. ### Claim 17 (depends on 1) The method of claim 1, wherein the second active agent is a monoamine oxidase B (MAO B) inhibitor. ### Claim 18 (depends on 1) The method of claim 1, wherein the second active agent is a catechol-O-methyl transferase (COMT) inhibitor. ### Claim 19 (depends on 1) The method of claim 1, wherein the second active agent is an anticholinergic. ### Claim 20 (depends on 1) The method of claim 1, wherein the second active agent comprises a bacterial isolate. ### Claim 21 (depends on 1) The method of claim 1, wherein the second active agent comprises purified bacteria belonging to a genus selected from the group consisting of: Clostridium, Collinsella, Dorea, Ruminococcus, Coprococcus, Prevotella, Veillonella, Bacteroides, Bacillus and a combination thereof. ### Claim 22 (depends on 1) The method of claim 1, wherein the induction dose is administered to the human subject twice-a-day for 4 days, and the maintenance dose is administered to the human subject twice-a-day every other day for 10 days. ### Claim 23 (depends on 1) The method of claim 1, wherein the therapeutic composition and the second active agent are in the same composition. ### Claim 24 (depends on 1) The method of claim 1, wherein the therapeutic composition and the second active agent are in different compositions.