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VIR-2482

Phase 1

Influenza A | Small molecule | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: Jun 9, 2022

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04033406Study of VIR-2482 in Healthy VolunteersPHASE1 COMPLETED 100 — — Aug 26, 2019Nov 1, 2021Jun 9, 20221 Australia
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Study Endpoints
Primary Endpoints
Number of participants with treatment-emergent adverse events.
Up to 12 months post-dose
Number of participants with abnormalities in vital signs.
Up to 12 months post-dose
Number of participants with abnormalities in electrocardiogram (ECG).
Up to 12 months post-dose
Number of participants with abnormalities in clinically significant laboratory findings.
Up to 12 months post-dose
Secondary Endpoints
Concentrations of VIR-2482 in serum
Up to 12 months post-dose
Incidence of anti-drug antibody (ADA) to VIR-2482
Up to 12 months post-dose
Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
Up to 12 months post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VIR-2482EXPERIMENTALVIR-2482
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
VIR-2482DRUGVIR-2482 given by intramuscular injection
PlaceboDRUGSterile normal saline (0.9% NaCl) given by intramuscular injection
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Male or Female age 18 to \< 65 years * Body mass index (BMI) of 18.0 kg/m\^2 to 32.0kg/m\^2 Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * History of influenza-like illness o...

Countries:Australia
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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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