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GNbAC1

Phase 2

Multiple Sclerosis, Relapsing-Remitting | Small molecule | Immunology |Tango Therapeutics, Inc.|Last Updated: Oct 20, 2020

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_CONTROLLEDDMC
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02782858Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MSPHASE2 COMPLETED 270Apr 1, 2016Dec 1, 2017Oct 20, 202012 Bulgaria, Croatia +10
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Study Endpoints
Primary Endpoints
Cumulative number of Gd-enhancing T1 lesions in brain MRI
Week 12 to 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose 1 GNbAC1EXPERIMENTALMonthly IV repeated dose
Dose 2 GNbAC1EXPERIMENTALMonthly IV repeated dose
Dose 3 GNbAC1EXPERIMENTALMonthly IV repeated dose
PlaceboPLACEBO_COMPARATORMonthly IV repeated dose
Interventions
NameTypeDescription
GNbAC1DRUGMonthly IV repeated dose
PlaceboDRUGMonthly IV repeated dose
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites12

Main Inclusion Criteria: * For male or female with reproductive potential, use of reliable means of contraception; * RRMS according to the 2010 revised McDonald criteria; * Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing ...

Countries:BulgariaCroatiaCzechiaEstoniaGermanyHungaryItalyPolandRussiaSerbiaSpainUkraine
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