Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VIR-2218 · 1 trial · 1 indication
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs
| Arm | Type | Description |
|---|---|---|
| VIR-2218 | EXPERIMENTAL | Drug: VIR-2218 VIR-2218 given by subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Drug: Placebo Saline given by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| VIR-2218 | DRUG | VIR-2218 given by subcutaneous injection |
| Placebo | DRUG | Saline given by subcutaneous injection |
Inclusion Criteria: * Male or female age 18 - 65; * Weight ≥ 40 kg to ≤ 125 kg; * 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 participation; *...
VIR-2218 is an investigational small molecule being developed for the treatment of chronic hepatitis B. It is currently in Phase 2 clinical development and has been studied in patients with chronic hepatitis B in mainland China.
VIR-2218 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALNY.
VIR-2218 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
VIR-2218 has been studied in a Phase 2 clinical trial with the identifier NCT04507269, titled 'Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China.' This trial was completed and enrolled 21 participants.
VIR-2218 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for chronic hepatitis B. The completed trial was conducted in China, and no approval status has been established.