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ALN-CFB

Phase 1

Paroxysmal Nocturnal Hemoglobinuria (PNH) | Small molecule | Hematology |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 17, 2026

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07187401A First-in-Human Safety and Efficacy Study of ALN-CFB, a Small Interfering RNA (siRNA) Targeting Complement Factor B, in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria With Persistent Anemia on a C5 InhibitorPHASE1 RECRUITING 24Feb 11, 2026Jul 15, 2031Mar 17, 20267 Canada, South Korea +1
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Study Endpoints
Primary Endpoints
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Through 365 Days
Severity of TEAEs
Through 365 Days
Secondary Endpoints
Concentrations of combined ALN-CFB and major metabolites in plasma
Through 365 Days
Concentrations of combined ALN-CFB and major metabolites in urine
Through 24 Hours following ALN-CFB administration
Absolute change from baseline in CFB concentration
Baseline, Through 365 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single-Ascending Dose EscalationEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ALN-CFBDRUGAdministered as defined in the protocol
PlaceboDRUGAdministered as defined in the protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: 1. Has been diagnosed with PNH confirmed by a history of high flow cytometry from prior testing 2. Treated with a stable dose of C5 inhibitor (eculizumab or approved eculizumab biosimilar, ravulizumab, or crovalimab) for at least 24 weeks prior to screening visit, as describ...

Countries:CanadaSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07187401primaryCompletionDate: changed
LOWMay 24, 2026NCT07187401studyFirstPostDate: changed