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APL-3007, pegcetacoplan

Phase 2

Geographic Atrophy Secondary to Age-related Macular Degeneration | Small molecule | Ophthalmology |Apellis Pharmaceuticals, Inc.|Last Updated: Jun 4, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07215390A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular DegeneratioPHASE2 RECRUITING 240Jun 23, 2025Nov 1, 2027Jun 4, 202668 United States
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Study Endpoints
Primary Endpoints
Change from baseline (CFB) in the area of artificial intelligence (AI)-based SD-OCT assessment of RPE lesion in the study eye
At month 12
Secondary Endpoints
CFB in the area of AI-based OCT assessment of photoreceptor degeneration in the study eye
At month 12
Safety & tolerability based on adverse event (AE) reporting
At month 12
Safety as assessed by Best Corrected Visual Acuity (BCVA)
At Month 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1 (APL-3007 Dose/Frequency 1 )EXPERIMENTALAPL-3007 SC + pegcetacoplan (APL-2)
Group 2 (APL-3007 Dose/Frequency 2)EXPERIMENTALAPL-3007 + pegcetacoplan (APL-2)
Group 3 (placebo)PLACEBO_COMPARATORPlacebo SC + pegcetacoplan (APL-2)
Interventions
NameTypeDescription
APL-3007, pegcetacoplan (APL-2)DRUGComplement C3 inhibitor
Placebo, SyfovreOTHERComplement C3 Inhibitor
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with better normal luminance visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be used as the ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07215390lastUpdatePostDate: changed
LOWJun 4, 2026NCT07215390lastUpdatePostDate: changed
LOWJun 4, 2026NCT07215390lastUpdatePostDate: changed
LOWJun 4, 2026NCT07215390lastUpdatePostDate: changed
LOWMay 26, 2026NCT07215390primaryCompletionDate: changed
LOWMay 24, 2026NCT07215390studyFirstPostDate: changed