Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VIR-2218, BRII-835, BRII-835 (VIR-2218)
Elebsiran · 10 trials · 8 indications
Number of Subjects with Adverse Events as assessed by CTCAE v5.0. In our planned analysis for this outcome measure, incidence is defined as the number of participants with treatment emergent AEs (TEAEs) in relation to the total number of participants in the cohort.
Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Number and percent of participants with 1 or more treatment-emergent adverse events within 28 days after the last dose by cohort.
Number and percent of participants with Grade 3 or higher local and/or systemic reactions within 28 days after the last dose by cohort.
Number and percent of participants with clinically significant changes from pre-vaccination laboratory values within 28 days after the last dose by cohort.
Number and percent of participants with serious adverse events within 6 months after the last dose by cohort.
Number and percent of participants with medically attended adverse events within 6 months after the last dose by cohort.
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Participants will receive BRII-835 (VIR-2218) for 32 weeks |
| Cohort B | EXPERIMENTAL | Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40 |
| Cohort C | EXPERIMENTAL | Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40 |
| BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα | EXPERIMENTAL | Participants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy. |
| BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα | EXPERIMENTAL | Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy. |
| Cohort 1 | EXPERIMENTAL | Participants will receive multiple doses of PEG-IFNα for 48 weeks. |
| Cohort 2 | EXPERIMENTAL | Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks. |
| Cohort 3 | EXPERIMENTAL | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks. |
| Cohort 4 | EXPERIMENTAL | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort). |
| Cohort 1a (VIR-2218) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 for up to 96 weeks total. |
| Cohort 1b (VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-3434 for up to 96 weeks total. |
| Cohort 2a (VIR-2218) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c. |
| Cohort 2b1 (VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. |
| Cohort 2b2 (VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c. |
| Cohort 2c (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 for up to 336 weeks. |
| Cohort 3 (VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c. |
| Cohort 4 (NRTI) | PLACEBO_COMPARATOR | Participants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3. |
| Cohort 5 (VIR-2218) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c. |
| Cohort 1a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total |
| Cohort 2a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple lead-in doses of VIR-2218, then combination therapy with VIR-2218 + VIR-3434 for 20 weeks total |
| Cohort 3a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks |
| Cohort 4a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 4 weeks |
| Cohort 5a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks |
| Cohort 6a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 11 weeks |
| Cohort 7a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 44 weeks |
| Cohort 8a (VIR-2218 + VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 for 20 weeks |
| Cohort 2b (VIR-3434) | EXPERIMENTAL | Participants will receive multiple doses of VIR-3434 for 20 weeks |
| Cohort 1c (VIR-2218 + VIR-3434 + PEG-IFNα) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 24 weeks |
| Cohort 2c (VIR-2218 + VIR-3434 + PEG-IFNα) | EXPERIMENTAL | Participants will receive multiple doses of VIR-2218 + VIR-3434 + PEG-IFNα for 48 weeks |
| Cohort 1d (VIR-3434 + PEG-IFNα) | EXPERIMENTAL | Participants will receive multiple doses of VIR-3434 + PEG-IFNα for 48 weeks |
| Cohort 1d | EXPERIMENTAL | VIR-2218 given by subcutaneous injection |
| Cohort 2d | EXPERIMENTAL | VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
| Cohort 3d | EXPERIMENTAL | VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
| Cohort 1e | EXPERIMENTAL | VIR-2218 given by subcutaneous injection |
| Cohort 2e | EXPERIMENTAL | VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
| Cohort 3e | EXPERIMENTAL | VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
| Cohort 1f | EXPERIMENTAL | VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
| Cohort 2f | EXPERIMENTAL | VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
| Cohort 3f | EXPERIMENTAL | VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection |
| Part A: SAD VIR-2218 50 mg | EXPERIMENTAL | Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC |
| Part A: SAD VIR-2218 100 mg | EXPERIMENTAL | Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC |
| Part A: SAD VIR-2218 200 mg | EXPERIMENTAL | Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC |
| Part A: SAD VIR-2218 400 mg | EXPERIMENTAL | Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC |
| Part A: SAD VIR-2218 600 mg | EXPERIMENTAL | Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC |
| Part A: SAD VIR-2218 900 mg | EXPERIMENTAL | Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC |
| Part A: SAD Placebo | PLACEBO_COMPARATOR | Healthy subjects received a single dose of placebo administered SC |
| Part B: MAD VIR-2218 20 mg | EXPERIMENTAL | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD VIR-2218 50 mg | EXPERIMENTAL | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD VIR-2218 100 mg | EXPERIMENTAL | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD VIR-2218 200 mg | EXPERIMENTAL | Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. |
| Part C: MAD VIR-2218 50 mg | EXPERIMENTAL | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart. |
| Part C: MAD VIR-2218 200 mg | EXPERIMENTAL | Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart. |
| Part B: MAD Placebo | PLACEBO_COMPARATOR | Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart. |
| Part C: MAD Placebo | PLACEBO_COMPARATOR | Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart. |
| Cohort 1a: Low Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost | EXPERIMENTAL | Participants assigned to Cohort 1a will receive a low dose prime vaccination of AdC7 vector on Day 1. They will receive a low dose boost vaccination of vector AdC6 on Day 91. |
| Cohort 1b: Low Dose VRON-0200-AdC6 Prime, No Boost | EXPERIMENTAL | Participants assigned to Cohort 1b will receive a low dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination. |
| Cohort 2a: High Dose VRON-0200-AdC7 Prime, VRON-0200-AdC6 Boost | EXPERIMENTAL | Participants assigned to Cohort 2a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive a high dose boost vaccination of AdC6 vector on Day 91. |
| Cohort 2b: High Dose VRON-0200-AdC6 Prime, No Boost | EXPERIMENTAL | Participants assigned to Cohort 2b will receive a high dose prime vaccination of AdC6 vector on Day 1. They will not receive a booster vaccination. |
| Cohort 3a: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, VRON-0200-AdC6 Boost | EXPERIMENTAL | Participants assigned to Cohort 3a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive VIR-2218 and VIR-3434 on Days 28, 56, 84, 112, 140, and 168. They will receive a high dose boost vaccination of AdC6 vector on Day 91. |
| Cohort 3b: High Dose VRON-0200-AdC7 Prime, 6 Doses VIR-2218 + VIR-3434, No Boost | EXPERIMENTAL | Participants assigned to Cohort 3a will receive a high dose prime vaccination of AdC7 vector on Day 1. They will receive VIR-2218 and VIR-3434 on Days 28, 56, 84, 112, 140, and 168. They will not receive a boost vaccination. |
| Cohort 1: Up to 8 moderate Renal Impairment participants and up to 8 matched healthy participants | EXPERIMENTAL | - |
| Cohort 2: Up to 8 severe Renal Impairment participants and up to 8 matched healthy participants | EXPERIMENTAL | - |
| Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first | EXPERIMENTAL | All participants in Cohort 1 will be receiving VIR-2218 monotherapy. |
| Cohort 2: CPT-C (severe HI) participants and matched healthy participants | EXPERIMENTAL | This arm is optional based on Cohort 1. All participants in Cohort 2 will be receiving VIR-2218 monotherapy. |
| Cohort 3: CPT-A (mild HI) participants and matched healthy participants | EXPERIMENTAL | This cohort is optional. All participants in Cohort 3 will be receiving VIR-2218 monotherapy. |
| Cohort 4: CPT-A (mild HI) participants and matched healthy participants | EXPERIMENTAL | All participants in Cohort 4 will be receiving VIR-3434 monotherapy. |
| Cohort 5: CPT-B (moderate HI) participants and matched healthy participants | EXPERIMENTAL | All participants in Cohort 5 will be receiving VIR-3434 monotherapy. |
| Cohort 6: CPT-C (severe HI) participants and matched healthy participants | EXPERIMENTAL | This arm is optional based on Cohort 5. All participants in Cohort 6 will be receiving VIR-3434 monotherapy. |
| Cohort 7: CPT-A (mild HI) and matched healthy participants | EXPERIMENTAL | All participants in Cohort 7 will be receiving VIR-3434 and VIR-2218 combination therapy. |
| Cohort 8: CPT-B (moderate HI) and matched healthy participants | EXPERIMENTAL | All participants in Cohort 8 will be receiving VIR-3434 and VIR-2218 combination therapy. |
| Cohort 9: CPT-C (severe HI) and matched healthy participants | EXPERIMENTAL | This arm is optional based on Cohort 8. All participants in Cohort 9 will be receiving VIR-3434 and VIR-2218 combination therapy. |
| Name | Type | Description |
|---|---|---|
| BRII-835 (VIR-2218) | DRUG | BRII-835 (VIR-2218) will be given by subcutaneous injection |
| BRII-179 (VBI-2601) with IFN-α | BIOLOGICAL | BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection |
| BRII-179 (VBI-2601) | BIOLOGICAL | BRII-179 (VBI-2601) will be administered by intramuscular injection |
| BRII-179 | BIOLOGICAL | BRII-179 will be given via intramuscular injection |
| PEG-IFNα | BIOLOGICAL | PEG-IFNα will be given via subcutaneous injection |
| BRII-835 | DRUG | BRII-835 will be given via subcutaneous injection |
| VIR-2218 | DRUG | VIR-2218 given by subcutaneous injection |
| VIR-3434 | DRUG | VIR-3434 given by subcutaneous injection |
| NRTI | DRUG | NRTI given orally. |
| pegylated interferon-alfa 2a | DRUG | pegylated interferon-alfa 2a given by subcutaneous injection |
| Placebo | DRUG | Sterile normal saline (0.9% NaCl) given by subcutaneous injection |
| VRON-0200-AdC6 | BIOLOGICAL | VRON-0200 chimpanzee adenovirus serotype 6 vaccine vector |
| VRON-0200-AdC7 | BIOLOGICAL | VRON-0200 chimpanzee adenovirus serotype 7 vaccine vector |
Inclusion Criteria: * Male or female aged 18 - 60 * Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2 * Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for...
Elebsiran is an investigational RNA therapy being developed for the treatment of chronic hepatitis B virus infection. It is also being studied in patients with chronic hepatitis D and in individuals with hepatic or renal impairment. Elebsiran has not been approved for any indication and remains in clinical development.
Elebsiran targets the HBV X region of the hepatitis B virus genome. It is a small interfering RNA (siRNA) designed to reduce viral gene expression and may thereby lower hepatitis B surface antigen levels. This mechanism is intended to complement existing antiviral therapies for chronic hepatitis B.
Elebsiran is being developed by Vir Biotechnology, Inc., which trades on the Nasdaq under the ticker VIR. The company is advancing the drug in multiple clinical trials, often in combination with other agents, for chronic hepatitis B and related conditions.
Elebsiran is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Several Phase 1 and Phase 2 trials have been completed or are ongoing to evaluate its safety, efficacy, and pharmacokinetics.
Elebsiran is being studied in several clinical trials, including NCT06491563, a Phase 2 study of regimens containing BRII-179, BRII-835, and PEG-IFNα in chronic hepatitis B; NCT05970289, a Phase 2 trial of BRII-835 (VIR-2218) plus PEG-IFNα; and NCT05844228, a completed Phase 1 study in renal impairment.
Yes, elebsiran is also known as VIR-2218 and BRII-835. These names refer to the same investigational compound. VIR-2218 is Vir Biotechnology's designation, while BRII-835 is the designation used by its collaboration partner Brii Biosciences.