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 therapy being studied for the treatment of chronic hepatitis B, a persistent viral infection of the liver. It is being developed by Alnylam Pharmaceuticals, Inc. and is currently in Phase 2 clinical development. It has not been approved by the FDA for any indication.
VIR-2218 targets the hepatitis B virus (HBV). Its target class is viral. By acting on HBV, the drug is designed to interfere with the virus that causes chronic hepatitis B infection. This mechanism is under investigation in clinical trials.
VIR-2218 is being developed by Alnylam Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ALNY. Alnylam is the sponsor of the clinical program evaluating VIR-2218 for chronic hepatitis B.
VIR-2218 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial for VIR-2218 has been completed.
VIR-2218 has been studied in one Phase 2 clinical trial, NCT04507269, titled "Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China." This trial enrolled 21 participants, was randomized, double-blind, and placebo-controlled, and has been completed. It was conducted in China.