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TD-1439

Phase 1

Undisclosed | Small molecule | Other |Theravance Biopharma, Inc.|Trials Updated: Jan 20, 2021

TD-1439 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Sep 2016

TD-1439 target and mechanism

Molecular targetNEP
Target classEnzyme
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment106

FDA Designations

No designations recorded

TD-1439 clinical trials

TD-1439 · 2 trials · 2 indications

Phase 1 2
NCT02954263Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly SubjectsHealthy Adults, Elderly Subjects
COMPLETED40 Analytics
NCT02903095Single Ascending Dose Study of TD-1439 in Healthy SubjectsHealthy Subjects
COMPLETED66 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly Subjects
Healthy Adults, Elderly SubjectsUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of TD-1439 in Healthy Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

The number of adverse events by severity, including changes in vital signs, physical examination, laboratory safety tests, and ECGs.
From Day 1 through end of study (Day 25)
Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
From Day 1 through end of study (Day 10)

Secondary Endpoints

Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)
Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)
Day 1 to 3 days after last dose (Day 17)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
TD-1439EXPERIMENTALCapsule formulation
PlaceboPLACEBO_COMPARATORCapsule formulation

Interventions

NameTypeDescription
TD-1439DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range19 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) 18 to 32 kg/m2 inclusive * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control * Women of non-childbearing potential are at least 2 years postmenopausal or are s...

Countries:United States
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Frequently asked questions about TD-1439

What is TD-1439?

TD-1439 is an investigational small molecule drug being developed by Theravance Biopharma, Inc. It has been studied in Phase 1 clinical trials in healthy adult and elderly subjects. The specific medical conditions it is intended to treat have not been publicly disclosed.

What does TD-1439 target?

TD-1439 targets neprilysin (NEP), an enzyme. By acting on this enzyme target, the small molecule is designed to modulate neprilysin activity. Neprilysin is an enzyme involved in the breakdown of certain peptides, and TD-1439 is being developed as an inhibitor of this target.

Who makes TD-1439?

TD-1439 is being developed by Theravance Biopharma, Inc., which trades on the Nasdaq under the ticker symbol TBPH. The company is the sponsor of the clinical studies conducted for this asset.

What phase is TD-1439 in?

TD-1439 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, and no active trials are currently listed for this asset.

What clinical trials is TD-1439 in?

TD-1439 has been evaluated in two completed Phase 1 trials. NCT02903095 was a single ascending dose study in 66 healthy subjects, and NCT02954263 was a multiple ascending dose study in 40 healthy adult and elderly subjects. Both were conducted in the United States.

What were the TD-1439 trials designed to measure?

Both TD-1439 Phase 1 trials were randomized, double-blind, and placebo-controlled studies conducted in healthy volunteers. NCT02903095 tested single ascending doses in 66 subjects, while NCT02954263 tested multiple ascending doses in 40 healthy adult and elderly subjects. Together they enrolled 106 participants.