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CB-183,315

Phase 3

Clostridium Difficile Infection | Small molecule | Gastrointestinal |Merck & Company, Inc.|Last Updated: Aug 22, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment818
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01598311A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)PHASE3 COMPLETED 608May 16, 2012Aug 25, 2015Aug 22, 2022 -
NCT01085591Study of CB-183,315 in Participants With Clostridium Difficile InfectionPHASE2 COMPLETED 210Apr 1, 2010May 13, 2011Sep 11, 201832 United States, Canada
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Study Endpoints
Primary Endpoints
Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)
Up to 3 days after EOT (up to Day 13)

The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or \>200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.

Percentage of Participants Experiencing an Adverse Event (AE)
Up to 30 days after EOT (up to Day 40)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.

Percentage of Participants Discontinuing From Study Treatment Due to an AE
Up to EOT (up to Day 10)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.

Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment
Baseline (Day 0) through Study Day 19

The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.

Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment
Baseline (Day 0) through Study Day 19

The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.

Secondary Endpoints
Number of Clinical Failure Events up to Day 40
Up to 30 days after EOT (up to Day 40)
Adjusted Percentage of Participants With Sustained Clinical Response at End of Study
Up to 40 days after EOT (up to Day 50)
Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period
Study Day 10 up to Study Day 40
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CB-183,315EXPERIMENTALParticipants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days.
VancomycinACTIVE_COMPARATORParticipants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
CB-183,315, 125 mgEXPERIMENTAL125 milligrams (mg) CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
CB-183,315, 250 mgEXPERIMENTAL250 mg CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
Vancomycin, 125 mgACTIVE_COMPARATOR125 mg vancomycin administered orally four times a day for 10 days.
Interventions
NameTypeDescription
CB-183,315DRUGCB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.
VancomycinDRUGVancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.
PlaceboDRUGPlacebo size 00 opaque hard gelatin capsules.
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Eligibility Criteria
Age Range18 Years — 89 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Is able to read and sign a consent form; * Is from ≥18 to \<90 years of age; * Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device; * Tests positive for Clostridium difficile; * If female, must not be pregnant or nursing and take a...

Countries:United StatesCanada
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