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KAN-101

Phase 2

Celiac Disease | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: Dec 18, 2025

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06001177A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac DiseasePHASE2 COMPLETED 55 — — Dec 13, 2023Jan 13, 2025Dec 18, 202528 United States, Canada +6
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Study Endpoints
Primary Endpoints
Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
Baseline and Day 29

KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.

Secondary Endpoints
Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC
From Day 15 pre-GC to Day 15 post GC
Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC
Baseline and Day 29
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
From the time the participant provided informed consent through Day 42.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALAll eligible participants will receive 3 intravenous (IV) infusions of KAN-101
Group 2PLACEBO_COMPARATORAll eligible participants will receive 3 intravenous (IV) infusions of placebo
Interventions
NameTypeDescription
KAN-101DRUGDose KAN-101 Intravenous (IV) Infusion
PlaceboDRUGPlacebo Intravenous (IV) Infusion
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Previous diagnosis of celiac disease based on histology and positive celiac serology * HLA-DQ2.5 genotype * Gluten-free diet for at least 12 months * Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening * Screening i...

Countries:United StatesCanadaFinlandGermanyIrelandIsraelNetherlandsPoland
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Competitive Landscape -Celiac Disease 5 trials
CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY1PHASE2Amlitelimab
Forte Biosciences Inc.FBRX1PHASE2FB102
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA1PHASE2TEV-53408
Barinthus Biotherapeutics plc Sponsored ADRBRNS1EARLY_PHASE1VTP-1000
TScan Therapeutics, Inc.TCRX1 — Undisclosed
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