Kodiak’s KSI-101 Shows 90% Success Rate in Achieving Retinal Dryness by Week 20 in MESI Study
Phase 1b Data Highlights Robust Efficacy for KSI-101 in Macular Edema Secondary to Inflammation
Kodiak Sciences has released promising new data from its APEX study of KSI-101 in patients with macular edema secondary to inflammation (MESI), showing that the investigational therapy led to complete absence of retinal fluid in 90% of patients at the highest two dose levels by week 20. The results suggest KSI-101 may emerge as a transformative option for a patient population with few highly effective, well-tolerated treatments.
Vision Gains and Anatomical Improvements Observed as Early as Week 4
The clinical benefits for MESI patients were both rapid and substantial. Meaningful gains in best corrected visual acuity (BCVA) appeared as early as week 4 and continued through week 20. More than half of patients in the top two dose groups experienced a 3-line (15-letter) improvement in visual acuity. Importantly, the majority reached an average BCVA of 79 letters (~20/25 Snellen equivalent), considered "almost perfect" vision for this group.
Data Table: Key Week 20 Results by Dose Level
| Dose Level | 2.5 mg (n=13) | 5 mg (n=13) | 10 mg (n=13) |
|---|---|---|---|
| Proportion with =15 Letter Gain (%) | 38 | 62 | 54 |
| Mean BCVA Gain (Letters) | 11.8 | 13.4 | 15.4 |
| Mean BCVA at Week 20 (Snellen eq.) | 74.5 (~20/32) | 79.1 (~20/25) | 79.0 (~20/25) |
| Mean Retinal Thickness Change (µm) | -151.2 | -218.1 | -230.1 |
| Mean OCT CST at Week 20 (µm) | 310.5 | 269.2 | 296.2 |
90% of Patients at Top Doses Achieved Retinal Dryness—A Key Clinical Marker
An outstanding 90% of patients in the 5 mg and 10 mg dose groups achieved and sustained the absence of both intraretinal and subretinal fluid—a central measure for disease control in MESI. These findings are notable since existing treatments for this inflammatory condition often fall short due to efficacy or safety limitations.
Favorable Safety Profile Positions KSI-101 as a Potential First-Line Therapy
Across all dose groups, KSI-101 was well tolerated, with a favorable safety profile reported through week 20. Given MESI's challenging risk-benefit landscape, the combination of robust vision and anatomical improvements without new safety signals makes KSI-101 stand out among investigational therapies.
Advancing to Phase 3: Fast Enrollment in PEAK and PINNACLE Trials
Following these encouraging APEX results, the top two KSI-101 doses (5 mg and 10 mg) have moved into pivotal Phase 3 studies (PEAK and PINNACLE), which are now enrolling faster than anticipated. The upcoming trials aim to confirm KSI-101’s effect in a broader patient spectrum, from those with severe vision loss to those with milder forms of MESI. Initial results from these studies are expected as early as late 2026.
KSI-101’s Unique Dual Mechanism May Drive Market Differentiation
KSI-101 leverages a bispecific mechanism, inhibiting both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), two key pathways implicated in inflammation and fluid accumulation in the retina. With no current biologic therapies directly addressing MESI as a distinct segment, KSI-101 could set a new standard for comprehensive disease control.
Takeaway: KSI-101 Data Point to a Potential Paradigm Shift for MESI
With robust vision gains, sustained anatomical response, and a clean safety profile through 20 weeks, Kodiak’s KSI-101 stands out as a strong contender to become the first unifying, first-line therapy for patients with MESI. The medical community will be watching closely as the pivotal trials move forward. Investors and physicians alike may want to track developments as Phase 3 results approach in 2026.
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