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An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection

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Trial Profile

An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Mar 2025

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At a glance

  • Drugs RBX 2660 (Primary)
  • Indications Clostridium difficile infections
  • Focus Therapeutic Use
  • Acronyms PUNCH Open Label; PUNCH SOS
  • Sponsors Rebiotix

Most Recent Events

  • 17 Mar 2025 According to a Ferring Pharmaceuticals media release, Health Canada has issued a Notice of Compliance, approving REBYOTA (fecal microbiota, live), a novel first-in-class microbiome-restoration therapy indicated for the prevention of recurrence of Clostridioides difficile infection (C. diff) in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff based on results form PUNCH-CD clinical program including Phase 3 PUNCH CD3 trial.
  • 11 Oct 2023 According to a Ferring Pharmaceuticals media release, company announced four poster presentations at Infectious Disease Week (IDWeek) 2023 for REBYOTA.
  • 11 Jul 2023 According to a Ferring Pharmaceuticals media release, the integrated safety analysis of three phase 2 trials (PUNCH CD, PUNCH CD2, PUNCH Open-Label) and two phase 3(PUNCH CD3, PUNCH CD3-OLS) in Therapeutic Advances in Gastroenterology.

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