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PTG-100

Phase 1

Celiac Disease | Small molecule | Gastrointestinal |Protagonist Therapeutics, Inc.|Last Updated: May 23, 2022

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_CONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04524221PTG-100 for Patients With Celiac DiseasePHASE1 COMPLETED 12Feb 26, 2021Apr 3, 2022May 23, 20221 United States
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Study Endpoints
Primary Endpoints
Percentage change in villous height-to crypt ratio
42 days

Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio

Secondary Endpoints
Change in celiac disease antibodies
42 days
Changes in celiac disease antibodies
42 days
CD3- positive intraepithelial lymphocyte density
42 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PTG-100EXPERIMENTALPatients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
PlaceboPLACEBO_COMPARATORPatients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
Interventions
NameTypeDescription
PTG-100DRUGPTG-100, 600mg taken twice daily in capsule form for 42 days
PlaceboDRUGPlacebo taken twice daily in capsule form for 42 days
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of celiac disease Exclusion Criteria: * Active GI disease or history of clinically significant diseases * Diagnosis of Crohn's disease or ulcerative colitis.

Countries:United States
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