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VIR-2218

Phase 2

Hepatitis D, Chronic | Small molecule | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Oct 14, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05461170SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.PHASE2 ACTIVE NOT_RECRUITING 95 — — Sep 17, 2022Aug 1, 2029Oct 14, 202520 Bulgaria, France +7
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Study Endpoints
Primary Endpoints
Proportion of participants with undetectable HDV RNA (< limit of detection [LOD]) or ≥ 2 log10 decrease in HDV RNA from baseline and alanine aminotransferase (ALT) normalization (ALT < upper limit of normal [ULN]) at Week 24
Up to 24 Weeks
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to 118 Weeks
Secondary Endpoints
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline and ALT normalization at Week 12, Week 48, Week 72, Week 96, Week 144, and Week 192.
Up to 192 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) or greater than/equal to 2 log10 decrease in HDV RNA from baseline at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
Up to 192 Weeks
Proportion of participants with undetectable HDV RNA (less than LOD) at Week 12, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 192.
Up to 192 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1a (VIR-2218)EXPERIMENTALParticipants will receive multiple doses of VIR-2218 for up to 96 weeks total.
Cohort 1b (VIR-3434)EXPERIMENTALParticipants will receive multiple doses of VIR-3434 for up to 96 weeks total.
Cohort 2a (VIR-2218)EXPERIMENTALParticipants will receive multiple doses of VIR-2218 for up to 132 weeks, then assign to Cohort 2c.
Cohort 2b1 (VIR-3434)EXPERIMENTALParticipants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.
Cohort 2b2 (VIR-3434)EXPERIMENTALParticipants will receive multiple doses of VIR-3434 for up to 132 weeks, then assign to Cohort 2c.
Cohort 2c (VIR-2218 + VIR-3434)EXPERIMENTALParticipants will receive multiple doses of VIR-2218 + VIR-3434 for up to 192 weeks.
Cohort 3 (VIR-3434)EXPERIMENTALParticipants will receive multiple doses of VIR-3434 for up to 112 weeks, then assign to Cohort 2c.
Cohort 4 (NRTI)PLACEBO_COMPARATORParticipants will receive NRTI for 12 weeks, then assign to Cohort 2c or Cohort 3.
Cohort 5 (VIR-2218)EXPERIMENTALParticipants will receive multiple doses of VIR-2218 for 12 weeks, then assign to Cohort 2c.
Interventions
NameTypeDescription
VIR-2218DRUGVIR-2218 given by subcutaneous injection
VIR-3434DRUGVIR-3434 given by subcutaneous injection
NRTIDRUGNRTI given orally.
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Eligibility Criteria
Age Range18 Years — 69 Years
SexALL
Healthy VolunteersNo
Study Sites20

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 ...

Countries:BulgariaFranceGermanyItalyMoldovaNetherlandsNew ZealandRomaniaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05461170primaryCompletionDate: changed
LOWMay 24, 2026NCT05461170studyFirstPostDate: changed