Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection
Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection
This study will evaluate the safety and efficacy of VE303 for participants with primary C.
 difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C.
 difficile infections (rCDI).
CONSORTIUM is a randomized, double-blind phase 2 study to evaluate safety, tolerability,
 PK/PD, and efficacy of VE303 in prevention of subsequent CDI-associated diarrhea compared
 with placebo following completion of at least 1 successful course of standard-of-care (SOC)
 antibiotics. VE303 or placebo capsules will be taken orally for 14 days after completion of a
 course of standard of care antibiotics. The proportion of subjects experiencing a confirmed
 CDI recurrence, within 8 weeks after the first dose of study treatment, will be compared
 across the study arms to understand the effectiveness of VE303 in preventing rCDI.

 The study will enroll approximately 146 to 300 subjects with a prior history of CDI diarrhea
 or first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must also
 have a positive C. difficile stool sample and have responded to standard of care (SOC)
 antibiotic treatment.
Partial Inclusion Criteria:

 1. Able and willing to provide written informed consent

 2. Subjects with a qualifying CDI episode who have a prior history of CDI diarrhea or
 first occurrence of CDI diarrhea with a higher risk for recurrence (≥ 65 years of age)

 3. CDI symptoms must have started within 30 days (inclusive) prior to the day of
 randomization

 4. The diarrhea is considered unlikely to have another etiology.

 5. Complete an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and
 up to 21 days of total duration

 6. Have a positive C. difficile stool

 7. Recovered from any complications of severe or fulminant CDI and clinically stable by
 the time of randomization.

 Partial Exclusion Criteria:

 1. History of diarrhea (defined as 3 or more loose stools per day lasting for at least 4
 weeks) that is not related to C. difficile infection within the 3 months prior to
 randomization.

 2. Known or suspected toxic megacolon and/or known small bowel ileus at the time of
 randomization.

 3. Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting,
 or ileus).

 4. Prior administration of genetically modified investigational live
 bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea

 5. History of administration of fecally-derived investigational live biotherapeutic
 products, or fecally-derived live bacterial isolates for CDI-associated diarrhea
 including fecal microbiota transplantation (FMT) within the last 6 months.

 6. Use of drugs that alter gut motility

 7. History of acute leukemia or hematopoietic stem cell transplantation or
 myelosuppressive chemotherapy within 2 months prior to randomization.

 8. Subjects with compromised immune system

 9. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within
 3 months prior to randomization or any history of total colectomy or bariatric surgery
 that disrupts the gastrointestinal lumen.

 10. History of confirmed celiac disease, inflammatory bowel disease, short gut,
 gastrointestinal tract fistulas, or ischemia.