TIMP-GLIA - Celiac Disease | Phase 2 | Takeda Pharmaceutical Company Limited | BiopharmaWatch

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TIMP-GLIA

Phase 2

Celiac Disease | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Aug 12, 2020

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-BlindCONTROLLEDDMCBiomarker

Total Trials2

Total Enrollment57

FDA Designations

No designations recorded

Clinical Trials (2)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03738475	Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease	PHASE2	COMPLETED	34	—	—	Nov 11, 2018	Jul 22, 2019	Aug 12, 2020	8	United States
NCT03486990	Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease	PHASE1	COMPLETED	23	—	—	Jan 23, 2018	Jul 22, 2019	Jun 5, 2020	4	United States

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Study Endpoints

Primary Endpoints

Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20

Baseline (Day 15/Day 1), Day 20

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.

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

From Day 1 up to Day 180

Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events

From Day 1 up to Day 180

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.

Number of Participants With Clinically Significant Physical Examination Findings

From Day 1 up to Day 60

Number of Participants With Clinically Significant Electrocardiograms (ECG) Findings

From Day 1 up to Day 60

Number of Participants With Clinically Significant Change From Baseline in Arterial Oxygen Saturation Levels

From Day 1 up to Day 60

Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values

From Day 1 up to Day 60

Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3

Baseline (Day 1 pre-dose) and Day 3

Baseline is defined as Day 1 pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7

Baseline (Day 1 pre-dose) and Day 7

Baseline is defined as Day 1 pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8

Baseline (Day 1 pre-dose) and Day 8

Baseline is defined as Day 1 pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10

Baseline (Day 1 pre-dose) and Day 10

Baseline is defined as Day 1 pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14

Baseline (Day 1 pre-dose) and Day 14

Baseline is defined as Day 1 pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38

Baseline (Day 1 pre-dose) and Day 38

Baseline is defined as Day 1 pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60

Baseline (Day 1 pre-dose) and Day 60

Baseline is defined as Day 1 pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1

Baseline (Day 1 pre-dose) and 15 minutes (min) post-dose on Day 1

Baseline was defined as Day 1 Pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1

Baseline (Day 1 pre-dose) and 30 min post-dose on Day 1

Baseline was defined as Day 1 Pre-dose.

Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2

Baseline (Day 1 pre-dose) and Day 2

Baseline was defined as Day 1 Pre-dose.

Number of Participants With Clinically Significant Change From Baseline in Hematology, Serum Chemistry, Coagulation, and Urinalysis

From Day 1 up to Day 60

Part A (Greater Than or Equal to [>=] 4.0 mg/kg) and Part B: Number of Participants With Clinically Significant Change From Baseline in Gliadin-Specific T-cell Proliferation and Cytokine Release Markers

Part A (>=4.0 mg/kg): Day 1 pre-dose up to 144 hours post-dose on Day 7; Part B: Day 8 pre-dose up to 144 hours post-dose on Day 14

Number of Participants With Clinically Significant Laboratory Abnormalities

From Day 1 up to Day 60

Secondary Endpoints

Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20

Baseline (Day 15/Day 1), Day 20

Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20

Baseline (Day 15/Day 1), Day 20

Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20

Baseline (Day 15/Day 1), Day 20

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Study Design & Arms

AllocationRANDOMIZED

MaskingQUADRUPLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

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.

Interventions

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.

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Eligibility Criteria

Age Range18 Years — 70 Years

SexALL

Healthy VolunteersNo

Study Sites8

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...

Countries:United States

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Competitive Landscape -Celiac Disease 5 trials

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

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