Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TIMP-GLIA · 2 trials · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| TIMP-GLIA | DRUG | 8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8. |
| Placebo | DRUG | Administered intravenously on days 1 and 8. |
Key Inclusion Criteria: 1. Male or nonpregnant female, ages 18 to 70 years inclusive, at Screening Visit. 2. Biopsy-confirmed CD (intestinal histology showing villous atrophy). 3. Positive for human leukocyte antigen (HLA)-DQ2 or HLA-DQ2/DQ8 - results will be obtained at Screening if unknown or res...
| 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 |
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.