Kodiak Sciences Shares Positive 20-Week Results from APEX Study of KSI-101 for MESI

Kodiak Sciences has released 20-week follow-up data from the APEX study, evaluating KSI-101 in patients with macular edema secondary to inflammation (MESI). This marks a continued progression of Kodiak’s pipeline following earlier 12-week results that demonstrated meaningful visual and anatomical improvements.

About KSI-101: A Bispecific Investigational Therapy

KSI-101 is described by Kodiak Sciences as a novel, potent, high-strength (100 mg/mL) antibody-based therapy with a bispecific mechanism of action, simultaneously targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF).

This dual-targeting approach aims to address inflammation and vascular permeability, both key factors in MESI pathogenesis.

Study Design and Dosing Cohorts

The APEX study includes two patient cohorts:

       • Cohort 1: Patients with diabetic macular edema (DME)

       • Cohort 2: Patients with macular edema secondary to inflammation (MESI)

Each cohort received one of three dosing levels of KSI-101:

       • 2.5 mg (n=13)

       • 5 mg (n=13)

       • 10 mg (n=13)

Clinical Outcomes

Earlier data from the trial demonstrated clinically meaningful gains in best-corrected visual acuity (BCVA) and rapid retinal drying as early as week 12. The latest week 20 results further reinforce KSI-101’s potential in the MESI treatment landscape.

Kodiak Sciences' Chairman and CEO, Victor Perlroth, MD, commented:

“These week 20 follow-up results suggest even more strongly the potential for KSI-101 to become a cornerstone therapy for the treatment of MESI. The data show that achieving complete retinal drying, meaningful visual acuity gains, and normalization of visual acuity is possible for most patients with MESI.”

Perlroth added that if these findings are confirmed in Kodiak’s upcoming Phase 3 PEAK and PINNACLE studies, KSI-101 could emerge as a safe, first-line unifying therapy across all MESI etiologies.

Velazquez-Martin, MD, Chief Medical Officer of Kodiak Sciences, emphasized two standout aspects of the data:

       • Retinal dryness in ≥90% of patients, defined by the absence of intraretinal and subretinal fluid

       • Achievement of near-perfect visual acuity at 20/25 Snellen equivalent

Dr. Velazquez-Martin also highlighted the rapid onset of action, noting that the majority of the drying effect was already observed by Week 1 across all dose levels, a potential differentiator in the competitive retina space.

Advancing to Phase 3: PEAK and PINNACLE Trials

Based on the results, Kodiak has selected the top two dose levels of KSI-101, 5 mg and 10 mg, to move forward into Phase 3 clinical trials PEAK (NCT06990399) and PINNACLE (NCT06996080).

These trials are identical in design, with the only variation being the patient population.