Granted Patent
B2
US 12,605,415 · App. 18/350,081 · Granted Apr 21, 2026
Compositions and methods
Inventors:
Gregory McKenzie (Arlington, MA); Mary-Jane Lombardo McKenzie (Arlington, MA); David N. Cook (Brooklyn, NY); Marin Vulic (Boston, MA); Geoffrey Von Maltzahn (Boston, MA); Brian Goodman (Boston, MA); John Grant Aunins (Doylestown, PA); Matthew R. Henn (Somerville, MA); David Arthur Berry (Brookline, MA); Jonathan Winkler (Boston, MA)
Assignee:
SERES THERAPEUTICS, INC.
A61K35/741A61K9/0053A61K9/48A61K9/4816A61K35/37A61K35/74A61K35/742A61K35/744A61K35/745A61K35/747A61K45/06C12N1/20Y02A50/30
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Abstract
Disclosed herein are therapeutic compositions containing non-pathogenic, germination-competent bacterial spores, for the prevention, control, and treatment of gastrointestinal diseases, disorders and conditions and for general nutritional health.
Claims (27)
1 . A therapeutic composition formulated for oral administration comprising a population of bacteria and a capsule, wherein the population of bacteria comprises spore-forming bacteria,
wherein the population of bacteria comprises a first bacteria and a second bacteria,
wherein the first bacteria is selected from Clostridium aldenense or a bacterial species having a 16S rDNA sequence with at least 97% identity to SEQ ID NO: 547, and
wherein the second bacteria is selected from Clostridium oroticum or a bacterial species having a 16S rDNA sequence with at least 97% identity to SEQ ID NO: 610.
2 . The therapeutic composition of claim 1 , wherein the spore-forming bacteria comprises germinable bacterial spores, sporulatable bacterial spores, or both.
3 . The therapeutic composition of claim 1 , wherein the composition comprises at least 1×10 4 colony forming units of bacteria per dose of the composition.
4 . The therapeutic composition of claim 1 , comprising an enteric coating.
5 . The therapeutic composition of claim 4 , wherein the enteric coating comprises a Eudragit polymer.
6 . The therapeutic composition of claim 1 , comprising bacteria in vegetative form.
7 . The therapeutic composition of claim 1 , comprising bacterial spores and vegetative bacteria.
8 . The therapeutic composition of claim 1 , comprising from 1 mg to 1000 mg of a lyophilized powder comprising one or more species of the population of bacteria.
9 . The therapeutic composition of claim 1 , wherein a dose of the therapeutic composition comprises a first capsule comprising a first population of bacteria and a second capsule comprising a second population of bacteria.
10 . The therapeutic composition of claim 1 , further comprising glycerol.
11 . The therapeutic composition of claim 1 , further comprising hypromellose.
12 . The therapeutic composition of claim 1 , wherein the population of bacteria further comprises one or more of Anaerotruncus colihominis, Ruminococcus obeum, Enterococcus faecalis, Clostridium innocuum, Clostridium ramosum, Bacteroides ovatus, Bacteroides vulgatus, Bacteroides thetaoiotaomicron, Escherichia coli, Clostridium bifermentans , or Blautia producta.
13 . The therapeutic composition of claim 1 , comprising at least 15 types of bacteria.
14 . The therapeutic composition of claim 1 , further comprising an excipient or a combination of excipients, wherein the weight fraction of the excipient or combination of excipients is about 95% or less, about 90% or less, about 85% or less, about 80% or less, about 75% or less, about 70% or less, about 65% or less, about 60% or less, about 55% or less, or about 50% or less of the total weight of the composition.
15 . The therapeutic composition of claim 1 , further comprising ascorbate.
16 . The therapeutic composition of claim 1 , further comprising sucrose.
17 . The therapeutic composition of claim 1 , further comprising microcrystalline cellulose.
18 . A therapeutic composition formulated for oral administration comprising a population of bacteria and a capsule, wherein the population of bacteria comprises spore-forming bacteria,
wherein the population of bacteria comprises a first bacteria and a second bacteria,
wherein the first bacteria is selected from Clostridium aldenense or a bacterial species having a 16S rDNA sequence with at least 97% identity to SEQ ID NO: 547,
wherein the second bacteria is selected from Clostridium oroticum or a bacterial species having a 16S rDNA sequence with at least 97% identity to SEQ ID NO: 610, and
wherein the therapeutic composition comprises a lyophilized composition comprising the population of bacteria and microcrystalline cellulose.
19 . The therapeutic composition of claim 18 , comprising bacterial spores and vegetative bacteria.
20 . The therapeutic composition of claim 18 , wherein the population of bacteria further comprises one or more of Anaerotruncus colihominis, Ruminococcus obeum, Enterococcus faecalis, Clostridium innocuum, Clostridium ramosum, Bacteroides ovatus, Bacteroides vulgatus, Bacteroides thetaoiotaomicron, Escherichia coli, Clostridium bifermentans , or Blautia producta.
Assignments (3)
CROSS-LICENSE AGREEMENT
Recorded Mar 30, 2026
From: SERES THERAPEUTICS, INC.
To: SOCIÉTÉ DES PRODUITS NESTLÉ S.A.
Reel/Frame 075314/0554 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 16, 2023
From: MCKENZIE, GREGORY; LOMBARDO MCKENZIE, MARY-JANE; COOK, DAVID N.; VULIC, MARIN; VON MALTZAHN, GEOFFREY; GOODMAN, BRIAN; AUNINS, JOHN GRANT; HENN, MATTHEW R.; BERRY, DAVID ARTHUR; WINKLER, JONATHAN
To: SERES HEALTH, INC.
Reel/Frame 065582/0265 →
CHANGE OF NAME
Recorded Nov 16, 2023
From: SERES HEALTH, INC.
To: SERES THERAPEUTICS, INC.
Reel/Frame 065600/0935 →
Continuity (14)
Continuation
PCTUS2014014745
· Feb 4, 2014
Provisional Application
61926918
· Jan 13, 2014
Provisional Application
61760606
· Feb 4, 2013
Provisional Application
61760585
· Feb 4, 2013
Provisional Application
61760584
· Feb 4, 2013
Provisional Application
61760574
· Feb 4, 2013
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