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Mycophenolate Mofetil

Phase 2

Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Apr 22, 2013

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00223301Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple SclerosisPHASE2 COMPLETED 24 — — Jul 1, 2004Mar 1, 2007Apr 22, 20131 United States
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Study Endpoints
Primary Endpoints
The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. Early MS for this study is defined at a definite diagnosis of less
Secondary Endpoints
To document changes in exacerbation frequency
To document the incidence of mild, moderate, and severe exacerbations in the treated groups.
To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI) as assessed by the Kaplan-Meier methodology.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Mycophenolate Mofetil (cellcept)DRUG -
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Eligibility Criteria
Age Range21 Years — 45 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Between the ages of 21-45 inclusive 2. Clinically definite, laboratory supported definite relapsing MS of less than or equal to two years in duration or monosymptomatic MS meeting CHAMPS criteria ref . 3. At least one exacerbation in the preceding two years 4. Written informe...

Countries:United States
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Competitive Landscape -Multiple Sclerosis 98 trials
CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY6PHASE3Frexalimab, MRI contrast-enhancing agents, Tolebrutinib, Teriflunomide, Cholestyramine
Novartis AG Sponsored ADRNVS23PHASE3Remibrutinib, Teriflunomide, Fingolimod, Ofatumumab, Siponimod
Biogen Inc.BIIB6PHASE3BIIB017, Interferon beta type 1a, Diroximel, Dimethyl, Fingolimod
Bristol-Myers Squibb CompanyBMY8PHASE3Ozanimod, Fingolimod, BMS-986368, CC-97540, Fludarabine
TG Therapeutics, Inc.TGTX8PHASE3Ublituximab, Fingolimod
Zenas BioPharma, Inc.ZBIO3PHASE3Orelabrutinib, Obexelimab
Immunic, Inc.IMUX3PHASE3IMU-838
Amgen Inc.AMGN1PHASE3Ocrelizumab, ABP 692
Eli Lilly and CompanyLLY1PHASE2LY3541860
Moderna, Inc.MRNA1PHASE2mRNA-1195
Kyverna Therapeutics, Inc.KYTX3PHASE2KYV-101, Standard lymphodepletion regimen, Anti-CD20 mAB, KYV-101 - 0.33 ×10^8 cells, KYV-101 - 1 ×10^8 cells
Tiziana Life Sciences Ltd.TLSA2PHASE2Foralumab TZLS-401 100 µg, Foralumab
Supernus Pharmaceuticals, Inc.SUPN1PHASE2Phase 2; Low Dose MYOBLOC, Phase 3; MYOBLOC
AstraZeneca PLCAZN1PHASE1AZD0120 - Regimen 1, AZD0120 - Regimen 2
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE1Obecabtagene autoleucel
TScan Therapeutics, Inc.TCRX1 — Undisclosed
Merck & Co., Inc.MRK1 — Mavenclad
Solana Company Class AHSDT1 — Undisclosed
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