Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TAK-101
TIMP-GLIA · 3 trials · 1 indication
IFN-γ SFUs were measured based on results of a gliadin-specific ELISpot assay using peripheral blood mononuclear cells (PBMCs). Gliadin-specific cluster of differentiation 4 (CD4) T cells were a small percentage of the PBMCs and responded to gliadin peptide stimulation in vitro by producing the IFN-γ cytokine. Baseline was defined as Day 15.
The spots formed by interferon-gamma-secreting T-cells were counted with an automated ELISPOT analyzer. The average spot-forming units (SFU) per antigen was calculated. A response was considered positive when the average SFU in wells with a given peptide was at least twice that of the average SFU in the no-peptide control wells. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Peripheral blood mononuclear cell is PBMC.
AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.0. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Drug-related adverse events are those that the investigator assessed as possibly or probably related to the study treatment.
Baseline is defined as Day 1 pre-dose.
Baseline is defined as Day 1 pre-dose.
Baseline is defined as Day 1 pre-dose.
Baseline is defined as Day 1 pre-dose.
Baseline is defined as Day 1 pre-dose.
Baseline is defined as Day 1 pre-dose.
Baseline is defined as Day 1 pre-dose.
Baseline was defined as Day 1 Pre-dose.
Baseline was defined as Day 1 Pre-dose.
Baseline was defined as Day 1 Pre-dose.
| Arm | Type | Description |
|---|---|---|
| Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 matching placebo intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24. |
| Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 matching placebo IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. |
| Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. |
| Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 matching placebo IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. |
| Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 50 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. |
| Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level. |
| Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE | EXPERIMENTAL | Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. |
| TIMP-GLIA | EXPERIMENTAL | 8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8. |
| Placebo | PLACEBO_COMPARATOR | Normal saline administered intravenously on days 1 and 8. |
| Part A, Cohort 1: 0.1 mg/kg | EXPERIMENTAL | TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. |
| Part A, Cohort 2: 0.5 mg/kg | EXPERIMENTAL | TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. |
| Part A, Cohort 3: 1.0 mg/kg | EXPERIMENTAL | TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. |
| Part A, Cohort 4: 2.0 mg/kg | EXPERIMENTAL | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. |
| Part A, Cohort 5: 4.0 mg/kg | EXPERIMENTAL | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. |
| Part A, Cohort 6: 8.0 mg/kg | EXPERIMENTAL | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. |
| Part B, Cohort 1: 2.0 mg/kg | EXPERIMENTAL | TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| Part B, Cohort 2: 4.0 mg/kg | EXPERIMENTAL | TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| Part B, Cohort 3: 8.0 mg/kg | EXPERIMENTAL | TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | TAK-101 matching placebo intravenous infusion |
| TAK-101 | DRUG | TAK 101 intravenous infusion |
| Gluten | DIETARY_SUPPLEMENT | Powder form (vital wheat gluten) |
| TIMP-GLIA | DRUG | 8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8. |
Inclusion Criteria: 1. Biopsy-confirmed CeD that is well-controlled, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD and with immunoglobulin A (IgA) tissue transglutaminase (tTG) \<2 × upper limit of normal (ULN) and IgG deamidated gliadin peptide (DGP) \<3 × U...
| 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 |
TIMP-GLIA is an investigational small molecule being developed for the treatment of celiac disease. It is designed to address the gastrointestinal condition, though its exact mechanism of action has not been disclosed. The drug is currently in clinical development and has not been approved by regulatory authorities.
TIMP-GLIA is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker TAK. Takeda is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TIMP-GLIA in adult patients with celiac disease.
TIMP-GLIA is in Phase 2 clinical development for celiac disease. It has completed a Phase 1 study and a Phase 2 study, both of which have finished. The drug remains investigational and is not yet approved for commercial use.
TIMP-GLIA has been evaluated in two completed clinical trials in the United States. The first, NCT03486990, was a Phase 1 study of safety, tolerability, and pharmacokinetics in 23 adults with celiac disease. The second, NCT03738475, was a Phase 2 study of safety, pharmacodynamics, efficacy, and pharmacokinetics in 34 adults with celiac disease.
TIMP-GLIA is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials for celiac disease. The drug is still in clinical development and has not received marketing authorization from the U.S. Food and Drug Administration or any other regulatory agency.