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VTP-1000

Phase 1

Celiac Disease | Monoclonal antibody | Gastrointestinal |Barinthus Biotherapeutics plc|Last Updated: Jan 9, 2026

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06310291VTP-1000 in Adults With Celiac DiseaseEARLY_PHASE1 RECRUITING 45 — — Aug 1, 2024Jun 1, 2026Jan 9, 202616 United States
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Study Endpoints
Primary Endpoints
Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs)
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Incidence and severity of treatment-emergent adverse events (TEAEs) , Serious Adverse Events (SAEs) , Adverse Events of Special Interest (AESIs) and adverse events leading to trial intervention discontinuation or trial withdrawal according to NCI CTCAE Version 5.0

Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Changes from baseline and clinically significant abnormalities in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0

Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Measurement of in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0

Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Measurement of standard hematology clinical laboratory safety parameters according to NCI CTCAE Version 5.0

Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Measurement of standard urinalysis clinical laboratory safety parameters according to NCI CTCAE Version 5.0

Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Changes from baseline and clinically significant abnormalities in 12-lead ECG parameters recorded according to NCI CTCAE Version 5.0

Changes from baseline and clinically significant abnormalities in vital signs
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Changes from baseline and clinically significant abnormalities in vital signs according to NCI CTCAE Version 5.0

Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Measurement of anti tTG immunoglobulin at screening and post treatment

Changes in physical examination findings
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Full physical examination required at screening; symptom-directed physical examination at all other clinic visits. Each physical examination must include a review of the administration sites.

Secondary Endpoints
PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component
SAD Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Matched Placebo (SAD)PLACEBO_COMPARATOR2 placebo comparators; 1 for each part of the study
VTP-1000 Dose 1 (SAD)EXPERIMENTAL3 dose levels in SAD and MAD parts of trial
VTP-1000 Dose 2 (SAD)EXPERIMENTAL3 dose levels in SAD and MAD parts of trial
VTP-1000 Dose 3 (SAD)EXPERIMENTAL3 dose levels in SAD and MAD parts of trial
Matched Placebo (MAD)PLACEBO_COMPARATOR2 placebo comparators; 1 for each part of the study
VTP-1000 Dose 1 (MAD)EXPERIMENTAL3 dose levels in SAD and MAD parts of trial
VTP-1000 Dose 2 (MAD)EXPERIMENTAL3 dose levels in SAD and MAD parts of trial
VTP-1000 Dose 3 (MAD)EXPERIMENTAL3 dose levels in SAD and MAD parts of trial
Interventions
NameTypeDescription
VTP-1000BIOLOGICALIntramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Matched PlaceboOTHERIntramuscular (IM) injection comprised of saline solution
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Diagnosis of celiac disease as confirmed by positive serology and intestinal histology * Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype * Participants who are on a well controlled gluten restricted diet * Negative or weak positive anti-tissue transglutaminase (tTG) I...

Countries:United States
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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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06310291primaryCompletionDate: changed
LOWMay 24, 2026NCT06310291studyFirstPostDate: changed