The Clostridioides Difficile Trial of REC-3964

A Phase 2 Clinical Study of REC-3964 in Adults for the Reduction of Recurrent Clostridioides Difficile Infection (CDI)

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile infection (CDI).

Study was terminated due to sponsor decision. This decision was not related to safety concerns.

Key Inclusion Criteria:

• Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrhea associated with a positive stool test for C. difficile toxin[s] prior to the preceding curative treatment.
• The CDI episode, severe or otherwise, must have resolved after receiving vancomycin with a standard duration of treatment. The participant must be randomized within 2 days of completing the preceding curative treatment.
• Have high risk for rCDI (a recurrent CDI episode within the last 6 months, age ≥65 years, immunocompromised state, or severe CDI with resolution prior to enrollment into the study).

Key Exclusion Criteria:

• Have an active, symptomatic, chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease.
• Diarrhea that requires on-study treatment with agents that would confound the interpretation of the study results.