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MK-6072

Phase 3

Clostridium Difficile Infection | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Sep 5, 2018

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,203
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01513239A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)PHASE3 COMPLETED 1,203Feb 1, 2012May 22, 2015Sep 5, 2018 -
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Study Endpoints
Primary Endpoints
Percentage of Participants With CDI Recurrence
12 weeks

CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea \[2 or fewer loose stools per 24 hours\] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =\< 14 day regimen.

Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment
Up to 4 weeks

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.

Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment
Up to 4 weeks

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.

Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment
Up to 4 weeks

A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.

Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment
Up to 4 weeks

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.

Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion
Up to 24 hours

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.

Secondary Endpoints
Percentage of Participants With Global Cure
12 weeks
Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode
12 weeks
Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-6072 + SOCEXPERIMENTALSingle intravenous (IV) infusion of 10 mg/kg MK-6072 + Standard of Care (SOC) for CDI
MK-3415A + SOCEXPERIMENTALSingle IV infusion of 10 mg/kg MK-3415A + SOC for CDI
Placebo + SOCPLACEBO_COMPARATORNormal saline IV infusion (0.9% sodium chloride) + SOC for CDI
Interventions
NameTypeDescription
MK-6072BIOLOGICALSingle IV infusion of MK-6072 (10 mg/kg of monoclonal antibody to C. difficile Toxin B)
MK-3415ABIOLOGICALSingle IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to C. difficile Toxin A and 10 mg/kg of monoclonal antibody to C. difficile Toxin B)
PlaceboBIOLOGICALSingle IV infusion of normal saline (0.9% sodium chloride)
SOCDRUGSOC for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participant has a diagnosis of CDI defined as: a) presence of diarrhea (passage of 3 or more loose stools in 24 or fewer hours); and b) positive test for toxigenic C. difficile from a stool collected no more than 7 days before study infusion. * Participant is receiving SOC the...

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