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TR-701

Phase 2

Skin Diseases, Infectious | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Nov 25, 2019

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-BlindCONTROLLED
Total Trials1
Total Enrollment192
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00761215Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure InfectionsPHASE2 COMPLETED 192Sep 17, 2008Feb 24, 2009Nov 25, 201912 United States
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Study Endpoints
Primary Endpoints
Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
7 to 14 days after the last dose of study drug

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
7-14 days after last dose of study drug

Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.

Secondary Endpoints
Response Rate at End of Therapy
last day of study treatment
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
7-14 days after last dose of study drug
Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set
21 to 28 days after the last study drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TR-701 200 mgEXPERIMENTAL -
TR-701 300 mgEXPERIMENTAL -
TR-701 400 mgEXPERIMENTAL -
Interventions
NameTypeDescription
TR-701 200 mgDRUGoral TR-701 200 mg for 5 to 7 days
TR-701 300 mgDRUGoral TR-701 300 mg for 5 to 7 days
TR-701 400 mgDRUGTR-701 400 mg for 5 to 7 days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms * Suspected or confirmed infection due to a gram-positive organism Exclusion Criteria: * Complicated skin and skin structure infection due to gram-negative organisms * Complicated...

Countries:United States
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