Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Revefenacin
TD-4208 700 μg · 4 trials · 4 indications
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.
A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes: * Death * Life-threatening situation. "Life-threatening" refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe * Inpatient hospitalization or prolongation of existing hospitalization * Congenital anomaly in the offspring of a participant who received study drug * Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug.
Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.
Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.
Clinically relevant changes identified based on change from baseline.
FEV1 = forced expiratory volume at one second
| Arm | Type | Description |
|---|---|---|
| Revefenacin inhalation solution 175 mcg QD. | EXPERIMENTAL | Revefenacin inhalation solution 175 mcg QD. |
| Placebo inhalation solution QD. | PLACEBO_COMPARATOR | Placebo inhalation solution QD. |
| Period 1: Revefenacin + Formoterol (Sequential) | EXPERIMENTAL | Days 1 to 21: Revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Revefenacin + Formoterol (Combo Solution) | EXPERIMENTAL | Days 22 to 42: After a 21 day period, the participants from the Revefenacin + Formoterol (Sequential) Arm will be dosed for 21 days with a combination of revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
| Period 1: Placebo + Formoterol (Sequential) | PLACEBO_COMPARATOR | Days 1 to 21: Placebo versions of revefenacin and formoterol will be sequentially administered in the morning. Formoterol will be administered again in the evening. |
| Period 2: Placebo + Formoterol (Combo Solution) | PLACEBO_COMPARATOR | Days 22 to 42: After a 21 day period, the participants from Placebo + Formoterol (Sequential) Arm the will be dosed for 21 days with a combination of placebo revefenacin and formoterol administered as a combined solution. Formoterol will be administered again in the evening. |
| Revefenacin | EXPERIMENTAL | Active Revefenacin and placebo (in place of Spiriva Handihaler®) |
| Spiriva Handihaler® | ACTIVE_COMPARATOR | Active Spiriva Handihaler® and placebo (in place of Revefenacin) |
| Sequence 1 | EXPERIMENTAL | Period 1 = Placebo; Period 2 = TD-4208 700 μg; Period 3 = TD-4208 350 μg; Period 4 = Ipratropium 500 μg |
| Sequence 2 | EXPERIMENTAL | Period 1 = TD-4208 700 μg; Period 2 = Ipratropium 500 μg; Period 3 = Placebo; Period 4 = TD-4208 350 μg |
| Sequence 3 | EXPERIMENTAL | Period 1 = TD-4208 350 μg; Period 2 = Placebo; Period 3 = Ipratropium 500 μg; Period 4 = TD-4208 700 μg |
| Sequence 4 | EXPERIMENTAL | Period 1 = Ipratropium 500 μg; Period 2 = TD-4208 350 μg; Period 3 = TD-4208 700 μg; Period 4 = Placebo |
| Name | Type | Description |
|---|---|---|
| Revefenacin 175 mcg in 3 ML Inhalation Solution | DRUG | Revefenacin |
| Placebo inhalation solution QD | DRUG | Placebo |
| Revefenacin | DRUG | Revefenacin is administered via a nebulizer. |
| Placebo | DRUG | Placebo version of Revefenacin is administered via a nebulizer. |
| Formoterol | DRUG | Administered sequentially in both revefenacin and placebo arms using a nebulizer. |
| Spiriva Handihaler® | COMBINATION_PRODUCT | Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device. |
| Placebo for Revefenacin | DRUG | Placebo administered as double blind, double dummy via nebulization. |
| Placebo for Spiriva Handihaler® | DRUG | Placebo administered as double blind, double dummy via Spiriva HandiHaler®. |
| TD-4208 700 μg | DRUG | - |
| TD-4208 350 μg | DRUG | - |
| Ipratropium 500 μg | DRUG | - |
Inclusion Criteria: * Key inclusion criteria include: * Males and females of Chinese ethnicity, at least 40 years of age. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effective method of contracepti...
TD-4208 700 μg is an investigational inhaled small molecule being studied for the treatment of chronic obstructive pulmonary disease, or COPD. It was evaluated in a Phase 2 trial that measured changes in FEV1, a standard lung function measure, in adults with COPD.
TD-4208 700 μg is being developed by Viatris Inc., which trades on Nasdaq under the ticker VTRS. Viatris is the sponsor associated with the clinical program for this COPD candidate.
TD-4208 700 μg is in Phase 2 development. It is an investigational therapy and has not been approved by the FDA. The Phase 2 study of TD-4208 700 μg has been completed, and no trials of this asset are currently listed as active.
TD-4208 700 μg has been studied in one completed Phase 2 trial, NCT03064113, titled Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD). The trial enrolled 32 participants in New Zealand, was randomized, double blind, and controlled, and included adults aged 40 years and older.
The Phase 2 trial of TD-4208 700 μg, NCT03064113, was a randomized, double blind, controlled study in participants with COPD. It enrolled 32 subjects in New Zealand, included both sexes, required a minimum age of 40 years, and did not enroll healthy volunteers. The study is completed.