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TD-4208

Phase 3

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |Viatris Inc.|Last Updated: Feb 24, 2022

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 Trials4
Total Enrollment2,299
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02459080Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)PHASE3 COMPLETED 619 — — Sep 1, 2015Sep 1, 2016Feb 24, 20221 United States
NCT02512510Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)PHASE3 COMPLETED 611 — — Sep 1, 2015Sep 1, 2016Feb 24, 20221 United States
NCT02518139A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)PHASE3 COMPLETED 1,060 — — Sep 1, 2015Jun 1, 2017Feb 24, 20221 United States
NCT02772159TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male SubjectsPHASE1 COMPLETED 9 — — Jun 1, 2015Apr 1, 2016Feb 24, 20221 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Trough FEV1 on Day 85
Day 85
Adverse Events: Frequency and Severity
Baseline to Day 365

To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)

[14C] total radioactivity in urine and reported as the recovery in urine as a percentage of the administered dose
up to 336 hours
[14C] total radioactivity in feces and reported as the recovery in feces as a percentage of the administered dose
up to 336 hours
Secondary Endpoints
Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
Days 15 to 85
Summary of Change From Baseline to Peak FEV1 After First Dose
0-2 hours after First Dose Day 1
Summary of Rescue Medication Use: Puffs Per Day
1-3 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TD-4208-1ACTIVE_COMPARATOR88 mcg
TD-4208-2ACTIVE_COMPARATOR175 mcg
PlaceboPLACEBO_COMPARATORPlacebo
TiotropiumACTIVE_COMPARATOR18 mcg
Study PopulationEXPERIMENTALOne dose each of treatments A: \[14C\] TD-4208 20 μg IV administered in a fasted state over 30 minutes. B: \[14C\] TD-4208 200 μg oral solution administered in a fasted state.
Interventions
NameTypeDescription
TD-4208DRUG -
PlaceboDRUG -
TiotropiumDRUGThere is not a placebo, there is an active comparator (Tiotropium) arm.
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject is a male or female subject 40 years of age or older Exclusion Criteria: * Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Countries:United States
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