Product candidate
Pre-clinical
Pre-IND
Phase 1
Phase 2/3
KSI-301 for wet AMD
Pre-clinical
Pre-IND
Phase 1
Phase 2/3
KSI-301 for diabetic eye disease
Pre-clinical
Pre-IND
Phase 1
Phase 2/3
KSI-501 for DME and Uveitis
Pre-clinical
Pre-IND
Phase 1
Phase 2/3
KSI-201 for treatment resistant wet AMD
Pre-clinical
Pre-IND
Phase 1
Phase 2/3
KSI-401 for dry AMD
Pre-clinical
Pre-IND
Phase 1
Phase 2/3

KSI-301 Clinical Development Strategy Overview

KSI-301 Phase 1 open-label, single injection, dose escalation study in retinal vascular disease has reached its primary endpoint

Key Findings To Date

  • Completed dosing of all patients (low, medium, and high dose)
  • No Drug Limiting Toxicities
  • No Drug Related Adverse Events
  • No intraocular inflammation
  • Optically clear media following injection

PHASE 1 STUDY – SELECTED ANTI-VEGF RESPONSIVE PATIENTS

Post-treatment Vision and OCT improvements validate the ABC PlatformTM

KSI-301 Phase 1 Study – Conclusions

  • KSI-301 safe and well-tolerated at all 3 dose levels
    • No dose-limiting toxicities, inflammation, serious adverse events, or test article related adverse events
    • 5 mg top dose selected for Phase 2
    • Lack of inflammation validates rigor of Kodiak’s Chemistry, Manufacturing, and Controls (CMC) approach
  • Bioactivity observed at every dose level
    • Pharmacodynamic effect (OCT imaging)
    • Improvements in patient function (visual acuity)
    • Patients enrolled included anti-VEGF non-responders, anti-VEGF sub-optimal responders, anti-VEGF responders and treatment naïve
  • Preliminary proof of concept demonstrated for KSI-301 and ABC Platform
    • KSI-301, a 950 kDa conjugate, is active in the eye with rapid time to onset and high magnitude responses