RBX2660 Clinical Studies

Rebiotix Inc., a Ferring Company, previously conducted several clinical research studies of RBX2660, now called REBYOTA™. In September of 2022, the FDA Approved REBYOTA™ (fecal microbiota, live-jslm) as a first-in-class therapeutic for the prevention of recurrence of Clostridioides difficile infection in adults. The following sections outline the studies conducted in support of this approval:

Study: PUNCH CD3-OLS (Completed)

This prospective, multicenter, open-label Phase 3 study was designed to assess the safety and tolerability of investigational drug RBX2660 (microbiota suspension) in a recurrent Clostridioides difficile infection (rCDI) population that is reflective of real-world clinical use. Participants in this study received RBX2660 and were monitored for up to 6 months thereafter. Participants deemed failures following the first dose per the defined study criteria, were eligible to receive an additional dose. Participants who received an open label dose were also followed for up to 6 months after administration.  

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Study: PUNCH CD3 (Completed)

This prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study was designed to assess the efficacy and safety of investigational drug RBX2660 in preventing recurrence of Clostridioides difficile infection (rCDI). Participants in this study received RBX2660 (microbiota suspension) or placebo and were monitored for up to 6 months thereafter. Participants who were deemed failures following the blinded dose per the defined study criteria were eligible to receive an open-label dose of RBX2660 via rectal administration. Participants who received an open label dose were followed for up to 6 months after administration. 

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Study: PUNCH Open Label (Completed)

This prospective, multicenter, open label Phase 2 study was designed to evaluate the safety and efficacy of investigational drug RBX2660 (microbiota suspension) in preventing Clostridioides difficile infection (rCDI). Participants in this study were monitored for up to 24 months following administration of the investigational drug. This study also included the evaluation of historical control data sets in which patients received standard-of-care antibiotics. 

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Study: PUNCH CD2 (Completed)

This Phase 2B study was a first-of-its-kind prospective, multi-center, randomized, double-blinded placebo-controlled clinical trial to evaluate the safety and efficacy of investigational drug RBX2660 (microbiota suspension) for recurrent Clostridioides difficile infection (rCDI). Participants in this study received RBX2660 or placebo and were monitored for up to 24 months following last dose. Participants who were deemed failures within per the defined study criteria were also eligible to receive up to 2 open-label doses of RBX2660. Participants who received the open label dose(s) were also followed for up to 24 months after administration.   

Additional Details: 

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Study: PUNCH CD (COMPLETED)

The first evaluation of investigational drug RBX2660 (microbiota suspension) assessed safety and efficacy in participants with recurrent Clostridioides difficile infection (rCDI). Participants in this study received the investigational drug and were monitored for up to 6 months following treatment. Participants who were determined to experience rCDI within the defined study criteria were eligible to receive an additional dose of RBX2660. Participants who received an additional dose were also followed for up to 6 months after administration.  

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The CDI-SCOPE clinical study is open for adults with recurrent infection that is only controlled by taking antibiotics.

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RBX2660 Clinical Studies

Rebiotix Inc., a Ferring Company, previously conducted several clinical research studies of RBX2660, now called REBYOTA™. In September of 2022, the FDA Approved REBYOTA™ (fecal microbiota, live-jslm) as a first-in-class therapeutic for the prevention of recurrence of Clostridioides difficile infection in adults. The following sections outline the studies conducted in support of this approval:

Study: PUNCH CD3-OLS (Completed)

This prospective, multicenter, open-label Phase 3 study was designed to assess the safety and tolerability of investigational drug RBX2660 (microbiota suspension) in a recurrent Clostridioides difficile infection (rCDI) population that is reflective of real-world clinical use. Participants in this study received RBX2660 and were monitored for up to 6 months thereafter. Participants deemed failures following the first dose per the defined study criteria, were eligible to receive an additional dose. Participants who received an open label dose were also followed for up to 6 months after administration.  

Additional Details:

  • Participants ≥18 years old with medical record documentation of either a current diagnosis or history of recurrent CDI as determined by the treating physician, or has had at least two episodes of severe CDI resulting in hospitalization
  • Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment 
  • Phase 3 prospective study enrolled up to 750 participants at multiple sites in the United States and Canada
  • Study treatment consists of rectal administration of a single study dose of RBX2660. There is no placebo control group and all enrolled participants receive active investigational drug.
  • Primary endpoint: Safety and tolerability of RBX2660 in participants with rCDI up to 6 months after last study treatment
  • Secondary endpoints: Efficacy of RBX2660 measured at 8 weeks post-treatment; Sustained clinical response through 6 months

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  • See listing on Clinicaltrials.gov for more information regarding this study: NCT03931941

Study: PUNCH CD3 (Completed)

This prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study was designed to assess the efficacy and safety of investigational drug RBX2660 in preventing recurrence of Clostridioides difficile infection (rCDI). Participants in this study received RBX2660 (microbiota suspension) or placebo and were monitored for up to 6 months thereafter. Participants who were deemed failures following the blinded dose per the defined study criteria were eligible to receive an open-label dose of RBX2660 via rectal administration. Participants who received an open label dose were followed for up to 6 months after administration. 

Additional Details:

  • Participants ≥18 years old with at least one recurrence of CDI after primary episode and have completed at least one round of standard-of-care oral antibiotics, or has had a least two episodes of severe CDI resulting in hospitalization within a year of enrollment 
  • Phase 3 prospective study expected to enroll up to 270 participants at multiple sites in the United States and Canada
  • Randomized, double-blinded delivery of a single dose of either RBX2660 or placebo via rectal administration
  • Primary endpoint: Efficacy of RBX2660 compared to placebo measured at 8 weeks
  • Secondary endpoints: Number of participants with adverse events through 6 months; Health Related Quality of Life (HRQOL) assessment

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  • See listing on Clinicaltrials.gov for more information regarding this study: NCT03244644

Study: PUNCH Open Label (Completed)

This prospective, multicenter, open label Phase 2 study was designed to evaluate the safety and efficacy of investigational drug RBX2660 (microbiota suspension) in preventing Clostridioides difficile infection (rCDI). Participants in this study were monitored for up to 24 months following administration of the investigational drug. This study also included the evaluation of historical control data sets in which patients received standard-of-care antibiotics. 

Additional Details:

  • Participants ≥18 years old with at least two recurrences of CDI after a primary episode and have completed at least two rounds of oral standard-of-care oral antibiotics, or has had a least two episodes of severe CDI resulting in hospitalization
  • Phase 2 prospective study expected to enroll up to 150 participants at multiple sites in the United States and Canada
  • Enrolled participants received one treatment consisting of two doses of RBX2660 (microbiota suspension) rectally administered.
  • Primary endpoint: Number of participants who were CDI-diarrhea free through 8 weeks
  • Secondary endpoints: Quality of life (SF-36) scores through 8 weeks; number of participants with major complications of recurrent rCDI from baseline through 24 months

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  • See listing on Clinicaltrials.gov for more information regarding this study: NCT02589847

Study: PUNCH CD2 (Completed)

This Phase 2B study was a first-of-its-kind prospective, multi-center, randomized, double-blinded placebo-controlled clinical trial to evaluate the safety and efficacy of investigational drug RBX2660 (microbiota suspension) for recurrent Clostridioides difficile infection (rCDI). Participants in this study received RBX2660 or placebo and were monitored for up to 24 months following last dose. Participants who were deemed failures within per the defined study criteria were also eligible to receive up to 2 open-label doses of RBX2660. Participants who received the open label dose(s) were also followed for up to 24 months after administration.   

Additional Details: 

  • Participants ≥18 years old with at least two recurrences of CDI after a primary episode and have completed at least two rounds of standard-of-care oral antibiotics, or has had a least two episodes of severe CDI resulting hospitalization
  • Phase 2B prospective study expected to enroll approximately 117 participants at multiple sites in the United States and Canada
  • Randomized, double-blinded administration of either RBX2660 or placebo via rectal administration. Groups included 2 Doses RBX2660 (Group A), 2 Doses of Placebo (Group B), or 1 Dose RBX2660/1 Dose Placebo (Group B)), with doses provided 7 days apart
  • Primary endpoint: Treatment success of Group A (2 Doses RBX2660) v. Group B (2 Doses placebo) at 8 weeks after last study treatment
  • Secondary endpoints: Treatment success between Group C (1 Dose RBX2660/1 Dose Placebo) v. Group B (2 Doses placebo) at 8 weeks; Treatment success between Group A (2 Doses RBX2660) and Group C (1 Dose RBX2660/1 Dose Placebo) at 8 weeks; Quality of life (SF-36) scores through 8 weeks; time to CDI recurrence after assigned treatment for Group A v. Group B at 8 weeks; time to CDI recurrence after assigned treatment for Group C v. Group B at 8 weeks; time to CDI recurrence after assigned treatment for Group A v. Group C at 8 weeks

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  • See listing on ClinicalTrials.gov for more information regarding this study: NCT02299570

Study: PUNCH CD (COMPLETED)

The first evaluation of investigational drug RBX2660 (microbiota suspension) assessed safety and efficacy in participants with recurrent Clostridioides difficile infection (rCDI). Participants in this study received the investigational drug and were monitored for up to 6 months following treatment. Participants who were determined to experience rCDI within the defined study criteria were eligible to receive an additional dose of RBX2660. Participants who received an additional dose were also followed for up to 6 months after administration.  

Additional Details:

  • Participants ≥18 years old with at least two recurrences of CDI after a primary episode and have completed at least two rounds of standard-of-care oral antibiotics, or have had at least two episodes of severe CDI resulting in hospitalization
  • Phase 2 prospective study enrolled 40 participants at multiple sites in the United States
  • Enrolled participants received one dose of RBX2660 via rectal administration
  • Primary endpoint: Incidence of Serious Adverse Events (SAEs) through 56 days after last treatment with RBX2660
  • Secondary endpoints: Long term safety through 6 months; Absence of rCDI at 56 days, Quality of life (SF-56), and post-treatment hospitalization

Learn More:

  • See listing on Clinicaltrials.gov for more information regarding this study: NCT01925417