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AKB-9778

Phase 2

Nonproliferative Diabetic Retinopathy | Small molecule | Ophthalmology |EyePoint, Inc.|Last Updated: Jun 27, 2023

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 Enrollment167
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03197870The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)PHASE2 COMPLETED 167 — — Jun 9, 2017Feb 9, 2019Jun 27, 202353 United States
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Study Endpoints
Primary Endpoints
Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps
Baseline to Week 48

Change from baseline to Week 48 in Diabetic Retinopathy Severity Scale Score in Study Eye by visit in the modified intent-to-treat population. ETDRS DR severity levels 10-85; ETDRS Steps 1-12

Secondary Endpoints
Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48
Baseline to Week 48
Mean Change From Baseline in DRSS in the Study Eye at Week 48
Week 48
Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.
Baseline to Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AKB-9778 15mg DailyEXPERIMENTALAKB-9778 15 mg (QD); To maintain masking, subjects will receive BID dosing with masked study medication administered as one dose of active and one dose of matching placebo
AKB-9778 15mg Twice DailyEXPERIMENTALAKB-9778 15 mg (BID)
Placebo Twice DailyPLACEBO_COMPARATORPlacebo Group: SC Phosphate-Buffered-Saline (PBS) (BID)
Interventions
NameTypeDescription
AKB-9778DRUGSubcutaneous AKB-9778 15mg
PlaceboDRUGSubcutaneous Placebo
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites53

Key Inclusion Criteria: * Adults 18 through 80 years of age (inclusive) * Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive) * No evidence of central involved diabetic macular edema * ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better) Key Exclusi...

Countries:United States
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