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ANX009

Phase 1

Lupus Nephritis | Monoclonal antibody | Immunology |Annexon, Inc.|Last Updated: Aug 22, 2024

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05780515A Study of ANX009 in Adult Participants With Lupus NephritisPHASE1 COMPLETED 7 — — Aug 9, 2022Oct 31, 2023Aug 22, 20247 Philippines, Taiwan
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Baseline (Week 1) up to Week 15
Secondary Endpoints
Change From Baseline in Free Complement Component 1q (C1q) Concentrations in Serum Over Time
Baseline (Week 1), up to Day 31
Change From Baseline in Complement Factor C4 Concentration and its Activation Product (Complement Component 4d [C4d]) in Plasma Over Time
Baseline (Week 1), up to End of Study (up to Week 15)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ANX009EXPERIMENTALParticipants will receive repeat doses of ANX009 administered by subcutaneous (SC) infusion 3 times weekly during the approximate 3-week intervention period.
Interventions
NameTypeDescription
ANX009BIOLOGICALANX009 will be administered per schedule specified in the arm description.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: * Participants who have a diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 Criteria * Has a history of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV with or without Clas...

Countries:PhilippinesTaiwan
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Competitive Landscape -Lupus Nephritis 26 trials
CompanyTickerTrialsLead PhaseDrugs
Novartis AG Sponsored ADRNVS5PHASE3ianalumab s.c. q4w, ianalumab s.c. q12w, Ianalumab, rapcabtagene autoleucel, Iptacopan
Viatris, Inc.VTRS1PHASE3Cenerimod
AstraZeneca PLCAZN2PHASE3Anifrolumab, Ravulizumab
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2Obecabtagene autoleucel
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Bristol-Myers Squibb CompanyBMY1PHASE2CC-97540, Fludarabine, Cyclophosphamide
Regeneron Pharmaceuticals, Inc.REGN1PHASE1Vonsetamig, Odronextamab
Kyverna Therapeutics, Inc.KYTX3PHASE1KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen, KYV-101
CRISPR Therapeutics AGCRSP1PHASE1CTX112
Artiva Biotherapeutics, Inc.ARTV1PHASE1AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Vertex Pharmaceuticals IncorporatedVRTX1PHASE1Povetacicept
Adicet Bio IncACET1PHASE1ADI-001, Fludarabine, Cyclophosphamide
Fate Therapeutics, Inc.FATE1PHASE2FT819
Nkarta, Inc.NKTX1PHASE1NKX019, Fludarabine, Cyclophosphamide
Century Therapeutics, Inc.IPSC1PHASE1CNTY-101, IL-2, Lymphodepleting Chemotherapy
GSK plc Sponsored ADRGSK1 — Undisclosed
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