Granted Patent B2

US 12,390,498 · App. 18/326,511 · Granted Aug 19, 2025

Inventors: Jessica Schneider (Cambridge, MA); Yun-Gi Kim (Watertown, MA); Bernat Olle (Cambridge, MA); Shilpa Reddy (Watertown, MA); Jason Norman (North Weymouth, MA); Juan Patarroyo (Lexington, MA)

Assignee: Vedanta Biosciences, Inc.

A61K35/747A23L5/00A23L33/135A61K9/0053A61K9/48A61K35/74A61K35/742A61K38/14C12N1/20A23K10/18A23K50/30A61K9/0031

Abstract

Claims (37)

1. A pharmaceutical composition comprising a purified bacterial mixture, wherein the purified bacterial mixture consists of 7 to 10 bacterial strains, wherein the purified bacterial mixture comprises at least 7 of:

(i) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 157;

(ii) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 129;

(iii) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 132;

(iv) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 137;

(v) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 124;

(vi) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 141;

(vii) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 146; and

(viii) a bacterial strain comprising a 16S rDNA sequence having at least 97% sequence identity to the nucleotide sequence of SEQ ID NO: 152,

wherein the bacterial strains are lyophilized.

2. The pharmaceutical composition of claim 1 , wherein the purified bacterial mixture comprises:

(i) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 157;

(ii) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 129;

(iii) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 132;

(iv) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 137;

(v) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 124;

(vi) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 141;

(vii) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 146; and

(viii) a bacterial strain comprising a 16S rDNA sequence having at least 99% sequence identity to the nucleotide sequence of SEQ ID NO: 152.

3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises a pH-sensitive composition comprising one or more enteric polymers.

4. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in the form of a capsule.

5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises between 1×10 7 and 1×10 10 colony forming units (CFUs) per bacterial strain.

6. The pharmaceutical composition of claim 1 , further comprising a pharmaceutically acceptable excipient.

7. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for oral administration.

8. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for rectal administration.

9. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for delivery to the intestine.

10. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for delivery to the colon.

11. A method of reducing the likelihood of a Clostridium difficile infection in a subject, the method comprising administering the pharmaceutical composition of claim 1 to the subject in a therapeutically effective amount to reduce the likelihood of the Clostridium difficile infection.

12. The method of claim 11 , wherein the Clostridium difficile infection is a first occurrence of a Clostridium difficile infection.

13. The method of claim 11 , wherein the Clostridium difficile infection is a recurrence of Clostridium difficile infection.

14. The method of claim 11 , wherein the subject is administered one or more doses of an antibiotic prior to the pharmaceutical composition.

15. The method of claim 14 , wherein the antibiotic is vancomycin, kanamycin, gentamicin, colistin, metronidazole, clindamycin, fidaxomicin, or cefoperazone.

16. The method of claim 14 , wherein the antibiotic is vancomycin.

17. A method to suppress an abnormal or excessive immune response in a subject comprising administering the pharmaceutical composition of claim 1 to the subject in a therapeutically effective amount to suppress the abnormal or excessive immune response.

18. The method of claim 17 , wherein the abnormal or excessive immune response is suppressed by inducing proliferation and/or accumulation of regulatory T cells.

19. The method of claim 17 , wherein the subject is administered one or more doses of an antibiotic prior to the pharmaceutical composition.

20. The method of claim 19 , wherein the antibiotic is vancomycin, kanamycin, gentamicin, colistin, metronidazole, clindamycin, fidaxomicin, or cefoperazone.

Assignments (2)

Continuity (8)

References Cited (147)