Expanded Access and Open Label Extension Study of SER-109 to Prevent Recurrent Clostridium Difficile Infection
Expanded Access and Open Label Extension Study of SER-109 to Prevent Recurrent Clostridium Difficile Infection
This is an open-label study for patients who have a recurrence of Clostridium difficile
 infection in the first 8 weeks of participation in the SERES-004 study. As the SERES-004
 study has completed enrollment, SERES-005 was amended to allow expanded access in accordance
 with 21 CFR 312.315 to SER-109 for patients with recurrent CDI who would have qualified for
 the SERES-004 study.
This is an open-label study of SER-109 in patients who received a dose of SER-109 or placebo
 in Study SERES-004 and experienced a CDI recurrence within 8 weeks of receipt of study drug.
 In addition, SERES-005 has been amended to expand access to treatment with SER-109 to an
 intermediate-size patient population of adults 18 years of age or older with recurrent
 Clostridium difficile infection (CDI) (a serious disease), who would have qualified for the
 SERES-004 study.
Inclusion Criteria:

 1. Signed informed consent, indicating that the patient understands the purpose of and
 procedures required for the study. Patients who are unable to provide informed consent
 will not be included in the study.

 2. Male or female patients ≥ 18 years of age.

 3. Previously enrolled in Study SERES-004 and had CDI recurrence within 8 weeks after
 receipt of study drug, OR If not previously enrolled in Study SERES-004, a documented
 history of ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current
 episode with ≥ 1 of the historical episodes having the date, test results, and
 antibiotic treatment received documented. Efforts should be made to acquire history of
 additional CDI episodes.

 4. If not previously enrolled in Study SERES-004, a qualifying episode of CDI as defined
 by:

 1. ≥ 3 unformed stools per day for 2 consecutive days

 2. A positive C. difficile stool test

 3. The requirement of CDI standard-of-care antibiotic therapy (defined as 10 to 21
 days of treatment with vancomycin or fidaxomicin but excluding pulse-tapered
 antibiotic regimens).

 4. An adequate clinical response defined as no evidence of diarrhea (< 3 unformed
 stools in 24 hours) for 2 or more consecutive days before randomization.

 5. If female, patient is non-lactating, and is either:

 1. Not of childbearing potential, defined as postmenopausal for at least 1 year or
 surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or
 hysterectomy.

 2. Of childbearing potential and is practicing at least 1 highly effective method of
 birth control including the barrier method; oral or parenteral contraceptives; a
 vasectomized partner; or abstinence from sexual intercourse. The investigator
 will discuss with the patient the option of practicing more than 1 of the above
 methods for the duration of the study.

 6. If male and partner is of childbearing potential, patient agrees to practice at least
 1 highly effective method of birth control for the duration of the study.

 7. Is not taking probiotics, or discontinues probiotics prior to study start and will not
 take probiotics for the duration of the study.

 Exclusion Criteria:

 1. Female patients who are pregnant, breastfeeding, lactating, or planning to become
 pregnant during the study.

 2. Known or suspected toxic megacolon and/or known small bowel ileus.

 3. Active irritable bowel syndrome with diarrhea within the previous 12 months.

 4. Admitted to or expected to be admitted to an acute care facility or intensive care
 unit for medical reasons (not just boarding). Patients discharged from an acute care
 facility before Day 1 or residing in nursing homes or rehabilitation facilities may be
 enrolled.

 5. Taking antibacterial therapy other than vancomycin (non-tapered) or fidaxomicin for
 most recent episode of CDI within 14 days before enrollment. A single-day antibiotic
 prophylactic regimen is permitted.

 6. Use of any probiotics.

 7. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within
 3 months before enrollment (this does not include appendectomy or cholecystectomy) or
 any history of total colectomy or bariatric surgery.

 8. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease,
 microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel
 disease in the past 24 months.

 9. Unable to stop loperamide, diphenoxylate/atropine, or cholestyramine before the study.

 10. Unable to stop opiate treatment unless on a stable dose, including PRN dosing, as of
 onset of diarrhea and no increase in dose planned for the duration of the study.

 11. Known positive stool cultures for other enteropathogens including, but not limited to,
 Salmonella, Shigella, and Campylobacter within the 30 days before enrollment.

 12. Known stool studies positive for ova and/or parasites within the 30 days before
 enrollment.

 13. Poor concurrent medical risks with clinically significant co-morbid disease such that,
 in the opinion of the investigator, the patient should not be enrolled.

 14. Received an investigational vaccine against C. difficile.

 15. Known active intravenous drug or alcohol abuse or other drugs of abuse.