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T2-18C3 therapeutic antibody

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Johnson & Johnson|Last Updated: Feb 21, 2021

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01427699A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 DiabetesPHASE2 COMPLETED 7Jun 30, 2011 -Feb 21, 20211 Switzerland
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Study Endpoints
Primary Endpoints
Safety and Tolerability
90 days

The safety and tolerability of T2-18C3 will be determined by observing patients for clinical adverse events, changes in vital signs, and changes in laboratory parameters such as hematology and chemistry.

Secondary Endpoints
Pharmacokinetics
90 days
Preliminary Efficacy
90 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
T2-18C3 therapeutic antibodyEXPERIMENTAL9 subjects will receive the T2-18C3 therapeutic antibody.
Interventions
NameTypeDescription
T2-18C3 therapeutic antibodyDRUG1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * American Diabetes Association (ADA) diagnostic criteria for Type 2 Diabetes (T2D) * HbA1c \>7.0% and ≤ 10% * Current T2D duration \> 3 months at Screening * T2D and other diseases must be stable. Stable disease is defined as disease which did not require a change in medication...

Countries:Switzerland
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