Kodiak Sciences Inc (Nasdaq:KOD), a precommercial retina-focused biotechnology company, announced on Monday that the first patients have been enrolled in the global Phase 3 ALTO trial evaluating KSI-501 in patients with diabetic macular oedema (DME).

KSI-501 is an investigational, first-in-class bispecific therapy built on Kodiak's ABC Platform and designed to potently inhibit two complementary pathways implicated in retinal vascular disease: interleukin (IL)-6-mediated inflammation and vascular endothelial growth factor (VEGF)-mediated vascular permeability and neovascularisation.

According to Kodiak, the ALTO trial is designed to demonstrate the superiority of bispecific (anti-VEGF, anti-IL-6) KSI-501 versus monospecific (anti-VEGF) aflibercept in patients with DME. ALTO is the second registrational Phase 3 trial of KSI-501, following the DAYBREAK study in patients with wet AMD.

ALTO explores whether dual inhibition of immune and vascular pathways can deliver deeper and more sustained disease control for patients with DME and evaluates two dosing regimens: one with intensive dosing and a second regimen with individualised dosing intervals of up to every six months.

Primary endpoint is the mean change in best-corrected visual acuity from baseline to the average of Week 48 and Week 52. The key secondary endpoint is the proportion of patients improving two or more steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48. Additional secondary and exploratory endpoints evaluate visual function, retinal anatomy, treatment burden and durability, and safety.