Approval Probability
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Adjusted LOA
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Daplusiran/Tomligisiran · 1 trial · 2 indications
The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV deoxyribonucleic acid (DNA) \<lower limit of quantification (LLOQ) and HBsAg not detected with or without HBsAb after a finite duration of therapy and off all HBV treatment. The number of participants achieving functional cure after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1A: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with high Hepatitis B surface antigen (HBsAg) level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM Treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 1B: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with high HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 2A: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with low HBsAg level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 2B: DAP/TOM + Bepirovirsen | EXPERIMENTAL | Participants with low HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Treatment Arm 2C: Placebo + Bepirovirsen | EXPERIMENTAL | Participants with low HBsAg level will receive Placebo in Treatment Stage 1. After Placebo treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment. |
| Name | Type | Description |
|---|---|---|
| Daplusiran/Tomligisiran Dose Level 1 | DRUG | Daplusiran/Tomligisiran dose level 1 will be administered |
| Daplusiran/Tomligisiran Dose Level 2 | DRUG | Daplusiran/Tomligisiran dose level 2 will be administered |
| Bepirovirsen | DRUG | Bepirovirsen will be administered |
| Placebo | DRUG | Placebo will be administered |
Inclusion Criteria: * Age: At least 18 years of age at the time of signing the informed consent * Documented chronic HBV infection greater than or equal to (\>=) 6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to ...
Daplusiran/Tomligisiran Dose Level 1 is being studied for the treatment of chronic hepatitis B virus infection. It is an investigational small molecule siRNA therapy given as part of a sequential treatment regimen that is followed by bepirovirsen in adults living with chronic hepatitis B.
Daplusiran/Tomligisiran Dose Level 1 is a small molecule siRNA therapy. Small interfering RNA agents are designed to target and reduce specific RNA transcripts, which is the mechanism this investigational candidate uses in chronic hepatitis B. It is being evaluated as part of a sequential regimen followed by bepirovirsen.
GSK plc, which trades under the ticker GSK, is the developer of Daplusiran/Tomligisiran Dose Level 1. The company is running the clinical program evaluating this siRNA candidate for chronic hepatitis B virus infection.
Daplusiran/Tomligisiran Dose Level 1 is in Phase 2 clinical development. It is an investigational therapy and has not been approved for commercial use. The Phase 2 study is currently active and no longer recruiting participants.
Daplusiran/Tomligisiran Dose Level 1 is being evaluated in the Phase 2 trial NCT06537414, titled A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B. The study is active but not recruiting and has enrolled 283 participants across multiple countries.
The Phase 2 trial NCT06537414 is a randomized, double-blind, controlled study of Daplusiran/Tomligisiran Dose Level 1 followed by bepirovirsen in adults with chronic hepatitis B. It enrolled 283 participants aged 18 years and older and is being conducted across sites in the United States, Europe, Asia, and other regions.