Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
S-warfarin · 1 trial · 1 indication
Participants with post-baseline (PB) ADAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).
Participants with PB NAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).
AUCinf of each of the following cytochrome P450 (CYP) isoenzyme substrates: midazolam (CYP3A), S-warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19). The AUC from zero to 12 hours (AUC0-12) was calculated for caffeine (CYP1A2).
| Arm | Type | Description |
|---|---|---|
| DAC HYP | EXPERIMENTAL | DAC HYP 150 mg by a subcutaneous (SC) injection using the pre-filled syringe (PFS) every 4 weeks for 24 weeks followed by a 20-week washout period. After completion of the washout period, participants may resume monthly DAC HYP 150 mg using the PFS for up to 3 additional years. Participants in the TP-DI sub-study will receive probe-drug cocktail administration at Weeks 43 and 53. The probe-drug cocktail consists of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg. The oral vitamin K is used to counteract warfarin's anticoagula nt effect prophylactically. |
| Name | Type | Description |
|---|---|---|
| Midazolam | DRUG | 5 mg |
| Caffeine | OTHER | 200 mg |
| S-warfarin | DRUG | 10 mg |
| Vitamin K | OTHER | 10 mg |
| Omeprazole | DRUG | 40 mg |
| Dextromethorphan | DRUG | 30 mg |
| BIIB019 (Daclizumab) | BIOLOGICAL | 150 mg in 1 ml PFS |
Key Inclusion Criteria: * Must have a confirmed diagnosis of RRMS according to McDonald criteria and previous cranial magnetic resonance imaging demonstrating lesion(s) consistent with MS * Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive * Must have had 1...
S-warfarin is the more pharmacologically active enantiomer of warfarin, a small-molecule vitamin K antagonist. Biogen Inc. (ticker BIIB) is developing it as an investigational therapy for relapsing-remitting multiple sclerosis, a neurological condition. It has reached Phase 3 clinical development.
S-warfarin is being studied as a treatment for relapsing-remitting multiple sclerosis, a form of MS characterized by episodes of new or worsening neurological symptoms followed by recovery. It is investigational and has not been established as a therapy for this indication outside of clinical research.
S-warfarin targets VKORC1, the vitamin K epoxide reductase complex subunit 1. It acts as an inhibitor of this enzyme, which is the target class for the compound. Inhibiting VKORC1 interferes with the vitamin K cycle and the gamma-carboxylation of vitamin K-dependent proteins.
Biogen Inc., which trades under the ticker BIIB, is the developer of S-warfarin. The company is advancing the small-molecule VKORC1 inhibitor in relapsing-remitting multiple sclerosis, where it has reached Phase 3 testing.
S-warfarin is in Phase 3 development. It is an investigational drug and is not approved for relapsing-remitting multiple sclerosis. One Phase 3 trial has been completed, and no trials are currently active.
S-warfarin has been evaluated in the Phase 3 trial NCT01462318, titled an open-label immunogenicity and pharmacokinetics study of daclizumab high yield process prefilled syringe in relapsing-remitting multiple sclerosis. That trial enrolled 133 participants across the United States, Czechia, Hungary, and Poland and is completed.