Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VTP-1000 · 1 trial · 1 indication
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 laboratory safety parameters according to NCI CTCAE Version 5.0
Measurement of in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0
Measurement of standard hematology clinical laboratory safety parameters according to NCI CTCAE Version 5.0
Measurement of standard urinalysis clinical laboratory safety parameters according to NCI CTCAE Version 5.0
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 according to NCI CTCAE Version 5.0
Measurement of anti tTG immunoglobulin at screening and post treatment
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.
| Arm | Type | Description |
|---|---|---|
| Matched Placebo (SAD) | PLACEBO_COMPARATOR | 2 placebo comparators; 1 for each part of the study |
| VTP-1000 Dose 1 (SAD) | EXPERIMENTAL | 3 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 2 (SAD) | EXPERIMENTAL | 3 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 3 (SAD) | EXPERIMENTAL | 3 dose levels in SAD and MAD parts of trial |
| Matched Placebo (MAD) | PLACEBO_COMPARATOR | 2 placebo comparators; 1 for each part of the study |
| VTP-1000 Dose 1 (MAD) | EXPERIMENTAL | 3 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 2 (MAD) | EXPERIMENTAL | 3 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 3 (MAD) | EXPERIMENTAL | 3 dose levels in SAD and MAD parts of trial |
| Name | Type | Description |
|---|---|---|
| VTP-1000 | BIOLOGICAL | Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component |
| Matched Placebo | OTHER | Intramuscular (IM) injection comprised of saline solution |
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 * Anti-tissue transglutaminase (tTG) IgA antibodies less than 2 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
VTP-1000 is an investigational monoclonal antibody being developed for the treatment of celiac disease. It is currently in early Phase 1 clinical development, with an ongoing trial enrolling adults with celiac disease in the United States.
VTP-1000 is being developed by Barinthus Biotherapeutics plc, a biopharmaceutical company listed on the stock exchange under the ticker BRNS. The company is conducting a Phase 1 clinical trial to evaluate the drug in adults with celiac disease.
VTP-1000 is in Phase 1 clinical development. The ongoing trial, NCT06310291, is an early Phase 1 study that is currently recruiting participants. The drug is investigational and has not yet been approved by regulatory authorities.
VTP-1000 is being evaluated in a single clinical trial, NCT06310291, titled 'VTP-1000 in Adults With Celiac Disease'. This early Phase 1 study is recruiting 45 participants in the United States and is randomized, double-blind, and placebo-controlled.
Yes, VTP-1000 is a monoclonal antibody. It is being studied as a potential treatment for celiac disease, a gastrointestinal condition. The drug is currently in early Phase 1 clinical trials to assess its safety and efficacy in affected adults.