Kodiak Sciences to Present Final Phase 1b Results for KSI-101 in Macular Edema Secondary to Inflammation
核心洞察
Kodiak Sciences will present final Phase 1b APEX study results for KSI-101, a bispecific protein targeting IL-6 and VEGF (搜索), at the Angiogenesis 2026 meeting on February 7.
The 24-week data demonstrate robust anatomic and visual improvements in patients with macular edema secondary to inflammation (搜索) (MESI (搜索)), regardless of underlying etiology or inflammation location.
KSI-101 represents a potential first-line unifying therapy for MESI (搜索), addressing an unmet medical need with no currently available intravitreal biologic therapies for this spectrum of diseases.
Kodiak Sciences Inc. announced that final results from its Phase 1b APEX study evaluating KSI-101 in patients with macular edema secondary to inflammation (搜索) (MESI (搜索)) will be presented at the virtual Angiogenesis annual meeting on February 7, 2026. Dr. Sumit Sharma, a retina and uveitis specialist at the Cole Eye Institute, will present the first-time end-of-study clinical results, including 24-week data.
Novel Bispecific Approach Shows Promise
KSI-101 is a novel, potent bispecific protein with high strength (100 mg/mL) that simultaneously targets interleukin-6 (IL-6) and vascular endothelial growth factor (搜索) (VEGF (搜索)). The dual-targeting approach addresses the underlying pathophysiology of MESI (搜索), which involves inflammation and blood retinal barrier disruption leading to retinal fluid accumulation and visual impairment.
According to Victor Perlroth, M.D., Chairman and CEO of Kodiak Sciences, "These final data continue to demonstrate robust anatomic and visual improvements in patients with MESI (搜索), regardless of the underlying etiology or location of inflammation, further supporting the clinical efficacy and safety profile of KSI-101 observed to date."
Addressing Unmet Medical Need
MESI (搜索) represents a heterogeneous group of diseases that clinically present with macular edema and visual impairment. The condition affects patients irrespective of inflammation location within the eye (anterior, intermediate, posterior, or all intraocular compartments) or specific etiology, including autoimmune-associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization cases.
Currently, no intravitreal biologic therapies are available to address the spectrum of MESI (搜索) diseases. Kodiak believes MESI represents a new market segment separate from the established anti-VEGF (搜索) market, potentially valued at $15 billion.
Phase 1b APEX Study Results
The completed Phase 1b APEX study evaluated KSI-101 in two cohorts: Cohort 1 included patients with diabetic macular edema (搜索) (DME), while Cohort 2 focused on patients with MESI (搜索). The study demonstrated that KSI-101 provides meaningful visual and anatomical gains in both patient populations and is well tolerated.
Notably, meaningful treatment responses were observed in the MESI (搜索) population regardless of inflammation location and specific MESI etiology, supporting KSI-101's potential as a unifying treatment for this diverse patient population.
Phase 3 Program Advancement
Based on APEX results, the top two dose levels tested were selected for advancement into the Phase 3 program. The PEAK and PINNACLE Phase 3 studies are currently actively enrolling MESI (搜索) patients, comparing 5 mg and 10 mg dose levels versus sham treatment.
Topline data from the PEAK study is expected in the fourth quarter of 2026, while PINNACLE results are anticipated in the second quarter of 2027. Both studies are designed to support a Biologics License Application (BLA) filing.
Broader Pipeline Development
Kodiak Sciences is developing a portfolio of three late-stage clinical programs focused on retinal diseases. Beyond KSI-101, the company is advancing tarcocimab and KSI-501 in Phase 3 studies for retinal vascular diseases, with topline data readouts expected in the first and third quarters of 2026, respectively.
The presentation will be available on the "Events and Presentations" section of Kodiak's website at the start of the Angiogenesis meeting event.