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KB801

Phase 1

Neurotrophic Keratitis | Monoclonal antibody | Other |Krystal Biotech, Inc.|Last Updated: Feb 27, 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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06999733A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic KeratitisPHASE1 RECRUITING 60 — — Jul 7, 2025Dec 1, 2027Feb 27, 20269 United States
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Study Endpoints
Primary Endpoints
To evaluate safety and tolerability of KB801 based upon assessment of adverse events (frequency, severity, relatedness).
8 weeks

Number of subjects with treatment related adverse events as assessed by CTCAE v5.

To evaluate the effect of KB801 on complete healing of the Persistent Corneal Epithelial Defect (PCED) in subjects with Stage 2 or Stage 3 NK
8 weeks

Proportion of subjects receiving KB801 exhibiting complete PCED closure at Week 8 compared to those receiving placebo.

Secondary Endpoints
To evaluate the effect of KB801 on complete healing of the PCED in subjects with Stage 2 or 3 NK
10 weeks
To evaluate the effect of KB801 on conventional healing of the PCED in subjects with Stage 2 or 3 NK
10 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KB801EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
KB801BIOLOGICALOphthalmic suspension of replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-based vector delivering functional, full-length human nerve growth factor (NGF)
PlaceboDRUGVehicle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. The subject must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions. 2. Aged ≥ 18 years at the time of informed consent. 3. Diagnosis of Stage 2 or ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06999733primaryCompletionDate: changed
LOWMay 24, 2026NCT06999733studyFirstPostDate: changed