Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD-6450 · 2 trials · 2 indications
Number, type, severity, and association of treatment emergent adverse events.
| Arm | Type | Description |
|---|---|---|
| TD-6450 | EXPERIMENTAL | TD-6450 capsules |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules |
| SAD TD-6450 | PLACEBO_COMPARATOR | Single ascending dose (Part A) |
| MAD TD-6450 | PLACEBO_COMPARATOR | Multiple ascending dose (Part B) |
| Food effect of TD-6450 | ACTIVE_COMPARATOR | Food effect will be assessed in Part A (SAD) of this study. |
| Name | Type | Description |
|---|---|---|
| TD-6450 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Subject is HCV antibody positive * Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals. * Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
TD-6450 is an investigational small molecule being studied for the treatment of hepatitis C, a viral infection of the liver. It was developed by Theravance Biopharma and has been evaluated in Phase 1 clinical trials. It is not an approved therapy and remains in early clinical development.
TD-6450 targets NS5A, a nonstructural hepatitis C viral protein that is essential for viral RNA replication and assembly. By binding NS5A, the drug is designed to interfere with the hepatitis C virus life cycle. TD-6450 is a small molecule direct-acting antiviral developed by Theravance Biopharma.
TD-6450 is developed by Theravance Biopharma, Inc., which trades on the Nasdaq under the ticker TBPH. The company advanced the compound as an internally discovered direct-acting antiviral candidate for hepatitis C. Theravance Biopharma is the sponsor of the clinical trials conducted for this asset.
TD-6450 is in Phase 1 clinical development. It has not been approved by the FDA for any indication and remains an investigational drug. Two Phase 1 trials have been completed, and no active trials are currently listed for the program.
TD-6450 has been studied in two completed Phase 1 trials. NCT02022306 was a single and multiple ascending dose study in healthy subjects that enrolled 111 participants. NCT02116543 was a multiple ascending dose study in hepatitis C infected subjects that enrolled 47 participants. Both were conducted in the United States.
Both TD-6450 trials were Phase 1, randomized, double-blind, and placebo-controlled. NCT02022306 enrolled 111 healthy volunteers, while NCT02116543 enrolled 47 subjects with hepatitis C. Together the two completed studies enrolled 158 participants, all aged 18 years or older, and both trials were conducted in the United States.