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MOR202

Phase 2

Glomerulonephritis | Small molecule | Nephrology |Biogen Inc.|Last Updated: Feb 7, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04733040Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R+ Membranous Nephropathy (aMN) (NewPLACE)PHASE2 COMPLETED 24Jan 20, 2021Dec 14, 2023Feb 7, 202525 Georgia, Germany +5
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Study Endpoints
Primary Endpoints
efficacy: percent change of anti-PLA2R antibody levels
3 months compared to baseline

efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN

Secondary Endpoints
efficacy: immunological complete response (ICR) rate
ICR rate at 3 months, 6 months, 12 months and 24 months
efficacy: overall proteinuria response (OPR) rate
OPR rate at 6 months, 12 months and 24 months.
safety: determined by the frequency, incidence and severity of TEAEs
through treatment completion, an average of 3 months per treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MOR202 5 DosesEXPERIMENTAL5 doses administered on Day 1, 8, 15, 29, and 57
MOR202 2 DosesEXPERIMENTAL2 doses administered on Day 1 and 15
Interventions
NameTypeDescription
MOR202DRUGMOR202 will be administered as an intravenous infusion
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form \[ICF\]). * Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g or proteinuria ≥ 3.5 g/24 h * Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m² (eGFR \>30 and \< 50 ml/min/1.73 m² can be ...

Countries:GeorgiaGermanyGreeceRussiaSouth KoreaTaiwanUnited Kingdom
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Competitive Landscape -Membranoproliferative Glomerulonephritis 2 trials
CompanyTickerTrialsLead PhaseDrugs
Apellis Pharmaceuticals, Inc.APLS2PHASE3Pegcetacoplan
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