Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VIR-2218 · 6 trials · 6 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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Cohort 1: Up to 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants | EXPERIMENTAL | - |
| Cohort 2: Up to 8 severe Renal Impairment (RI) participants and 6 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| VIR-2218 | DRUG | VIR-2218 given by subcutaneous injection |
| VIR-3434 | DRUG | VIR-3434 given by subcutaneous injection |
| NRTI | DRUG | NRTI given orally. |
| PEG-IFNα | DRUG | PEG-IFNα given by subcutaneous injection |
| 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 |
Inclusion Criteria: * Male or female ages 18 to \< 70 years at screening * Chronic HDV infection for \>/= 6 months * On NRTI therapy for at least 12 weeks prior to day 1 * ALT\>ULN and \< 5x ULN * Non-cirrhotic and CPT-A cirrhotic Exclusion Criteria: * Any clinically significant chronic or acute ...
VIR-2218 is an investigational small molecule being developed for chronic hepatitis B and chronic hepatitis D. It is also being studied in patients with renal impairment and hepatic impairment to evaluate how those conditions affect the drug's pharmacokinetics and safety.
VIR-2218 targets hepatitis B virus RNA. It is designed to interfere with viral RNA, which is part of the hepatitis B virus life cycle. This mechanism is being studied as a potential treatment for chronic hepatitis B and chronic hepatitis D infections.
VIR-2218 is being developed by Vir Biotechnology, Inc., a company traded on the NASDAQ under the ticker symbol VIR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic hepatitis B and hepatitis D.
VIR-2218 is in Phase 2 clinical development. It is being studied in the SOLSTICE trial for chronic hepatitis D, which is currently active but not recruiting. The drug is also being evaluated in Phase 1 trials for hepatic and renal impairment, and it is not yet approved by regulatory authorities.
VIR-2218 is being studied in several clinical trials. NCT05461170 (SOLSTICE) is a Phase 2 trial for chronic hepatitis D. NCT05484206 is a Phase 1 trial in hepatic impairment, and NCT05844228 is a Phase 1 trial in renal impairment. NCT03672188, a Phase 1 trial in chronic hepatitis B, has been completed.
No, VIR-2218 and VIR-3434 are different investigational drugs. They are being studied together in a clinical trial (NCT05484206) that evaluates the effect of hepatic impairment on the pharmacokinetics and safety of both drugs, but they are separate compounds with distinct mechanisms.