TD-1473 - Ulcerative Colitis, Active Moderate | Phase 1 | Theravance Biopharma, Inc. | BiopharmaWatch

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TD-1473

Phase 1

Ulcerative Colitis, Active Moderate | Small molecule | Immunology |Theravance Biopharma, Inc.|Last Updated: Sep 30, 2021

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 Enrollment40

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT02818686	TD-1473 for Active Ulcerative Colitis (UC)	PHASE1	COMPLETED	40	—	—	Oct 3, 2016	Mar 29, 2018	Sep 30, 2021	8	United States, Georgia +2

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Study Endpoints

Primary Endpoints

Treatment-emergent Adverse Events (TEAE)

Baseline to end of follow-up (a maximum of 42 days)

Number of participants who experience one or more treatment-emergent Adverse Events (TEAE)

Moderate or Severe Treatment-emergent Adverse Events (TEAE)

Baseline to end of follow-up (a maximum of 42 days)

Number of participants who experience one or more moderate or severe treatment-emergent Adverse Events (TEAE)

Serious Treatment-emergent Adverse Events (TEAE)

Baseline to end of follow-up (a maximum of 42 days)

Number of participants who experience one or more serious treatment-emergent Adverse Events (TEAE)

Clinical Laboratory Measurements

Baseline to end of follow-up (a maximum of 42 days)

Number of participants who experienced a Clinically Significant Clinical Laboratory Measurements

Electrocardiogram

Baseline to Day 14

Number of participants who experienced a Clinically Significant Electrocardiogram (ECG) Result

Vital Signs

Baseline to end of follow-up (a maximum of 42 days)

Number of participants who experienced a Clinically Significant Vital Sign Measurement

Cmax in plasma

Day 1 and Day 14

Maximum Observed Plasma Concentration of TD-1473

Tmax in plasma

Day 1 and Day 14

Time to Reach Maximum Observed Plasma Concentration (Cmax) of TD-1473

Tlast in plasma

Day 1 and Day 14

Time to Last Quantifiable Concentration of TD-1473

Ctrough in plasma

Day 14 (Pre-dose)

Trough Concentration of TD-1473

AUC0-4 in plasma

Day 1 and Day 14

Area Under the Concentration-time Curve from Time Zero to 4 hours Post-Dose of TD-1473

Ctissue in plasma

Day 28

Tissue Concentration of TD-1473

Secondary Endpoints

C-reactive protein (CRP)

Baseline, Day 14 and Day 28

Fecal Calprotectin

Baseline and Day 28

Partial Mayo score

Baseline, Day 14 and Day 28

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Study Design & Arms

AllocationRANDOMIZED

MaskingQUADRUPLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
TD-1473 low dose	EXPERIMENTAL	10 subjects will be randomized to receive low-dose TD-1473 orally daily for 28 days
TD-1473 mid dose	EXPERIMENTAL	10 subjects will be randomized to receive mid-dose TD-1473 orally daily for 28 days
TD-1473 high dose	EXPERIMENTAL	10 subjects will be randomized to receive high-dose TD-1473 orally daily for 28 days
Placebo	PLACEBO_COMPARATOR	10 subjects will be randomized to receive placebo orally daily for 28 days

Interventions

Name	Type	Description
TD-1473	DRUG	-
Placebo	DRUG	-

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Eligibility Criteria

Age Range18 Years — 75 Years

SexALL

Healthy VolunteersNo

Study Sites8

Inclusion Criteria: * Has a history of ulcerative colitis diagnosis at least 3 months prior to screening * Is intolerant, refractory, or only partially responsive to aminosalicylates, corticosteroids, immunomodulators, or biologics. If subject is currently receiving an oral aminosalicylate, he or s...

Countries:United StatesGeorgiaMoldovaRomania

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