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CAD106

Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Novartis AG|Last Updated: Mar 5, 2021

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_CONTROLLED
Total Trials3
Total Enrollment266
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01097096Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer PatientsPHASE2 COMPLETED 177 — — Mar 1, 2010Dec 1, 2012Mar 5, 202131 United States, Belgium +8
NCT00795418Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's PatientsPHASE2 COMPLETED 31 — — Oct 1, 2008 -Dec 17, 202010 United States
NCT00411580Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)PHASE1 COMPLETED 58 — — Jun 1, 2005Dec 1, 2008Mar 29, 20133 Sweden
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Study Endpoints
Primary Endpoints
Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring).
Screening and through the end of the study to Week 90
Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)
52 weeks
Tolerability/safety assessments (physical/neurol.exam., ECG, vital signs, standard and special immunological laboratory evaluations, MRIs, EEGs, AE/SAE monitoring).
at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
Antibody titers (IgM and IgM titers against amyloid and carrier protein).
at multiple timepoints including but not limited to baseline and through the end of the study to Week 52
Secondary Endpoints
Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)
Screening and through the end of the study to Week 90
Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)
Screening and at week 8
Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo
Screening and through the end of the study to Week 90
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CAD106 150μg + Adjuvant 1 at middle doseACTIVE_COMPARATOR -
CAD106 150μg + Adjuvant 1 at low doseACTIVE_COMPARATOR -
Placebo + Adjuvant 1 at middle dosePLACEBO_COMPARATOR -
CAD106 150μg + Adjuvant 2 at middle doseACTIVE_COMPARATOR -
CAD106 150μg + Adjuvant 2 at low doseACTIVE_COMPARATOR -
Placebo + Adjuvant 2 at middle dosePLACEBO_COMPARATOR -
CAD106 450μg + either Adjuvant 1 or 2 at middle doseACTIVE_COMPARATOR -
CAD106 450μg + either Adjuvant 1 or 2 at low doseACTIVE_COMPARATOR -
Placebo + either Adjuvant 1 or 2 at middle dosePLACEBO_COMPARATOR -
CAD106EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTALCAD106
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
CAD106BIOLOGICAL150μg and 450μg doses were reconstituted and administered via intramuscular injection
PlaceboBIOLOGICALIdentical placebo to CAD106 administered via intramuscular injection
AlumBIOLOGICALAn adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106
MF59BIOLOGICALAn adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
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Eligibility Criteria
Age RangeN/A — 85 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Male and/or female patients below 85 years of age (inclusive) * Diagnosis of mild Alzheimer's Disease * Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to c...

Countries:United StatesBelgiumCanadaGermanyItalyNetherlandsNorwaySpainSwedenSwitzerland
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Competitive Landscape -Alzheimer's Disease 68 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline/Trospium Chloride, Xanomeline Enteric, BMS-986446
Eli Lilly and CompanyLLY13PHASE3Donanemab, Dexamethasone, Remternetug, Mevidalen, LY3954068
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937, NIO752
Merck & Co., Inc.MRK2PHASE2MK-1167, MK-2214
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE, PI-2620
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, LLCIGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288, ALN-APP
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT-
Denali Therapeutics Inc.DNLI1PHASE1DNL628
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002 .
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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