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PPI-668 · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin | ACTIVE_COMPARATOR | PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination |
| PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin | ACTIVE_COMPARATOR | PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination |
| PPI-668, BI 207127 Dose 1, and Faldaprevir | ACTIVE_COMPARATOR | PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination |
| PPI-668 tablet followed by capsule | EXPERIMENTAL | On day 1, one 200 mg PPI-668 tablet will be administered. On day 6, two 100 mg PI-668 capsules will be administered. |
| PPI-668 capsule followed by tablet | EXPERIMENTAL | On day 1, two 100 mg PI-668 capsules will be administered. On day 6, one 200 mg PPI-668 tablet will be administered. |
| midazolam | EXPERIMENTAL | potential effects of PPI-668 on midazolam pharmacokinetics |
| omeprazole | EXPERIMENTAL | potential effects of PPI-668 on omeprazole pharmacokinetics |
| telaprevir | EXPERIMENTAL | potential effects of PPI-668 on telaprevir pharmacokinetics |
| Part I: single dose escalation in healthy volunteers | EXPERIMENTAL | There will be three sequential single dose cohorts: Cohort A: PPI-668 dose D1 or placebo Cohort B: PPI-668 dose D2 or placebo Cohort C: PPI-668 dose D3 or placebo |
| Part I: multiple dose administration to healthy volunteers | EXPERIMENTAL | Upon completion of the single dose escalation phase, an additional cohort will receive repeat doses: Cohort D: highest well-tolerated dose from Cohorts A-C or placebo once daily for five days |
| Part II: multiple dose escalation in HCV subjects | EXPERIMENTAL | Upon completion of Part I, there will be 3, and potentially 4, sequential cohorts of HCV patients: Cohort E (genotype-1): PPI-668 dose E1 or placebo Cohort F (genotype-1): PPI-668 dose E2 or placebo Cohort G (genotype-1): PPI-668 dose E3 or placebo Cohort H (genotype-1): if necessary for dose-response assessment; dose to be determined Cohort I (genotype-2 or -3): PPI-668 dose E4 or placebo |
| Name | Type | Description |
|---|---|---|
| PPI-668 | DRUG | - |
| BI 207127 Dose 1 | DRUG | - |
| BI 207127 Dose 2 | DRUG | - |
| Faldaprevir | DRUG | - |
| Ribavirin | DRUG | - |
| BI 207127 Placebo | DRUG | - |
| PPI-668 tablet | DRUG | - |
| PPI-668 capsule | DRUG | - |
| Midazolam | DRUG | - |
| Omeprazole | DRUG | - |
| Telaprevir | DRUG | - |
| Placebo | DRUG | capsules |
Inclusion Criteria: 1. Male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control 2. Body weight greater than 40 kg and less than 125 kg 3. Clinical diagnosis of chronic hepatitis C 4. Treatment-naïve f...
PPI-668 is an investigational small molecule being developed for the treatment of chronic hepatitis C. It has been studied in patients with hepatitis C virus (HCV) genotype 1 and in healthy volunteers for pharmacokinetic assessments. The drug is not approved and remains in clinical development.
PPI-668 is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol BCRX. The company has conducted clinical trials of PPI-668 in the United States, Australia, and New Zealand.
PPI-668 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study of PPI-668 in combination with BI 207127 and faldaprevir, with and without ribavirin, for the treatment of chronic hepatitis C. The drug is investigational and not FDA approved.
PPI-668 has completed three clinical trials: NCT01448200, a Phase 1 study in healthy volunteers and patients with HCV genotype 1; NCT01786382, a drug interaction study with midazolam and omeprazole; and NCT01859962, a Phase 2 study of PPI-668 with BI 207127 and faldaprevir in chronic hepatitis C. All trials are completed.
PPI-668 is a small molecule antiviral agent. The specific molecular target of PPI-668 has not been disclosed in the available clinical trial information. It is being studied for its ability to treat chronic hepatitis C virus infection.
PPI-668 is a distinct investigational drug being developed by BioCryst Pharmaceuticals. It has been studied in combination with other antiviral agents, including BI 207127 and faldaprevir, but it is not the same as those drugs. No alternative names for PPI-668 have been reported.