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GNbAC1

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

GNbAC1 · 1 trial · 1 indication

Phase 2 1
NCT02782858Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MSMultiple Sclerosis, Relapsing-Remitting
COMPLETED270 Analytics
PHASE2COMPLETED
Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
Multiple Sclerosis, Relapsing-Remitting
NCT02782858270
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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 to 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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Frequently asked questions about GNbAC1

What is GNbAC1 used for in multiple sclerosis?

GNbAC1 is an investigational small molecule being studied for the treatment of relapsing-remitting multiple sclerosis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does GNbAC1 target?

GNbAC1 is a HERV-W Env antagonist, meaning it targets the HERV-W envelope protein. This mechanism is being investigated for its potential role in treating relapsing-remitting multiple sclerosis.

Who makes GNbAC1?

GNbAC1 is being developed by Tango Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TNGX.

What phase is GNbAC1 in?

GNbAC1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency.

What clinical trials is GNbAC1 in?

GNbAC1 has one completed Phase 2 clinical trial, identified as NCT02782858. This trial assessed the HERV-W Env antagonist GNbAC1 for efficacy in multiple sclerosis and enrolled 270 participants with relapsing-remitting multiple sclerosis.

Is GNbAC1 the same as a HERV-W Env antagonist?

Yes, GNbAC1 is a HERV-W Env antagonist. The clinical trial NCT02782858 explicitly describes GNbAC1 as a HERV-W Env antagonist, indicating that this is the drug's mechanism of action.