Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INX-08189 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 200 mg INX-08189 Fasted | EXPERIMENTAL | Cohort 1: 200 mg INX-08189 QD fasted for seven days |
| Placebo QD Fasted | PLACEBO_COMPARATOR | Cohort 1: Placebo QD fasted for seven days |
| 100 mg INX-08189 with Ribavirin | EXPERIMENTAL | Cohort 2: 100 mg INX-08189 100 mg dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID, the AM dose will be taken 4 hours after INX-08189 so it may be taken with food) |
| Placebo QD dosed with ribavirin | ACTIVE_COMPARATOR | Cohort 2: Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID) |
| 100 mg INX-08189 with a low-fat meal | EXPERIMENTAL | Cohort 3: 100 mg INX-08189 with a low-fat meal QD x7 days |
| Placebo with low-fat meal | PLACEBO_COMPARATOR | Cohort 3: Placebo administered with a low-fat meal QD for 7 days |
| 100 mg INX-08189 Fasted | EXPERIMENTAL | Cohort 4: 100 mg INX-08189 BID fasted x7 days |
| Placebo BID Fasted | PLACEBO_COMPARATOR | Cohort 4: Placebo BID fasted x7 days |
| Arm 1: INX-08189 (9 mg) or Placebo | EXPERIMENTAL | - |
| Arm 2: INX-08189 (25 mg) or Placebo | EXPERIMENTAL | - |
| Arm 3: INX-08189 (50 mg + 9 mg) or Placebo | EXPERIMENTAL | - |
| Arm 4: INX-08189 (50 mg) or Placebo | EXPERIMENTAL | - |
| Arm 5: INX-08189 (9 mg) or Placebo + Ribavirin | EXPERIMENTAL | - |
| Arm 6: INX-08189 (25 mg) or Placebo + Ribavirin | EXPERIMENTAL | - |
| Arm 7: INX-08189 (100 mg) or Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 200 mg INX-08189 Fasted | DRUG | 200 mg capsule INX-08189 fasted x7 days |
| Placebo QD Fasted | DRUG | Placebo capsule QD fasted x7 days |
| 100 mg INX-08189 QD | DRUG | 100 mg INX-08189 capsule QD x 7 days |
| Placebo QD | DRUG | Placebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID) |
| 100 mg INX-08189 with low-fat meal | DRUG | INX-08189 100 mg capsule, with low-fat meal QD for seven days |
| Placebo with low-fat meal | DRUG | Placebo capsule administered with a low-fat meal QD for seven days |
| 100 mg INX-08189 BID Fasted | DRUG | 100 mg INX-08189 BID fasted x7 days |
| Placebo BID Fasted | DRUG | Placebo BID fasted x7 days |
| ribavirin | DRUG | - |
| INX-08189 | DRUG | Capsules, Oral, 9 mg, Once Daily, 7 Days |
| Placebo matching with INX-08189 | DRUG | Capsules, Oral, 0 mg, Once daily, 7 days |
Inclusion Criteria: Screening visit (Visit 1), subject criteria: * Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at least 18 kg/m2 but not exceeding 36 kg/m2; * Diagnosed with chronic HCV by at least 1 previous polymerase chain reaction (PCR) result prior to Vi...
INX-08189 is an investigational small molecule being developed for the treatment of chronic hepatitis C virus infection, specifically HCV genotype 1, in treatment-naive patients. It is in Phase 1 clinical development and has not been approved for any indication.
INX-08189 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the Phase 1 clinical trials evaluating the drug in patients with chronic genotype 1 hepatitis C.
INX-08189 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently in active trials. The drug remains investigational and has not received FDA approval for any indication.
INX-08189 has been evaluated in two completed Phase 1 trials: NCT01445795, which studied safety, pharmacokinetics, and pharmacodynamics with ribavirin and food effect in 50 chronically infected genotype 1 HCV patients, and NCT01250366, which studied safety and pharmacokinetics in 70 treatment-naive HCV patients. Both trials were conducted in the United States and Puerto Rico.
INX-08189 is a small molecule developed for hepatitis C virus genotype 1. The specific molecular target is not provided in the available information.