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JBT-101

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |Corbus Pharmaceuticals Holdings, Inc.|Trials Updated: Apr 4, 2018

JBT-101 development status

Highest phase Phase 2
Registered trials 3 across 2 sponsors since Jun 2015

JBT-101 target and mechanism

Molecular targetCB2
Target classReceptor
ModalitySmall molecule

Also known as JBT-101 (lenabasum), anabasum

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

JBT-101 clinical trials

JBT-101 · 1 trial · 1 indication

Phase 2 1
NCT02465450Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic FibrosisCystic Fibrosis
COMPLETED85 Analytics
PHASE2COMPLETED
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events.
84 days of treatment

Secondary Endpoints

JBT-101 (Lenabasum) Plasma Concentrations on Day 84
Day 84
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JBT101 (lenabasum) 1 mgEXPERIMENTALJBT-101 1 mg once a day on Days 1-28
JBT-101 (lenabasum) 5 mgEXPERIMENTALJBT-101 5 mg once a day on Days 1-28
PlaceboPLACEBO_COMPARATORPlacebo once a day on Days 1-28.
JBT-101 (lenabasum) 20 mg QDEXPERIMENTALJBT-101 20 mg once a day on Days 29-84.
JBT-101 (lenabasum) 20 mg BIDEXPERIMENTALJBT-101 20 mg twice daily on Days 29-84.
Placebo BIDPLACEBO_COMPARATORPlacebo twice daily on Days 29-84.

Interventions

NameTypeDescription
JBT-101 (lenabasum)DRUGSubjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.
PlaceboOTHERSubjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria: 1. Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test; 2. Two well-characteri...

Countries:United StatesBelgiumFranceGermanyItalyPolandUnited Kingdom
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Competitive Landscape -Cystic Fibrosis 20 trials

Frequently asked questions about JBT-101

What is JBT-101 used for?

JBT-101 is an investigational small molecule being studied for the treatment of cystic fibrosis. It has been evaluated in a Phase 2 clinical trial in adults with cystic fibrosis. It is not approved for any indication and remains in clinical development.

What does JBT-101 target?

JBT-101 targets the CB2 receptor, a receptor target. By acting on CB2, the drug is designed to modulate receptor activity as part of its investigational mechanism in cystic fibrosis. It is a small molecule therapeutic.

Who is developing JBT-101?

JBT-101 is being developed by Corbus Pharmaceuticals Holdings, Inc., which trades under the ticker CRBP. The company is the sponsor of the clinical program evaluating the drug in cystic fibrosis.

What phase is JBT-101 in?

JBT-101 is in Phase 2 development. It has completed one Phase 2 trial in cystic fibrosis. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is JBT-101 in?

JBT-101 has been studied in the Phase 2 trial NCT02465450, titled Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis. The trial enrolled 85 participants across the United States, Belgium, France, Germany, Italy, Poland, and the United Kingdom, and it is completed.

Is JBT-101 the same as lenabasum?

Yes, JBT-101 is also known as lenabasum. The names refer to the same investigational small molecule developed by Corbus Pharmaceuticals for cystic fibrosis.