Final APEX Phase 1b Clinical Results for Kodiak's KSI-101 in Macular Edema Secondary to Inflammation to be Presented at Angiogenesis 2026
Rhea-AI Summary
Kodiak Sciences (Nasdaq: KOD) will present final Phase 1b APEX clinical results for KSI-101 in macular edema secondary to inflammation (MESI) at the virtual Angiogenesis meeting on February 7, 2026.
Dr. Sumit Sharma will present Week 24 end-of-study data at 5:15 PM ET; the presentation will be posted in the company's Events and Presentations section. The company says the final data show robust anatomic and visual improvements and continue to support the safety profile of KSI-101 while Phase 3 PEAK and PINNACLE studies remain actively enrolling.
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News Market Reaction – KOD
In the Feb 4 session, KOD declined 6.87%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 05 | APEX Week 20 data | Positive | -1.5% | Week 20 APEX data showing strong fluid resolution and vision gains in MESI. |
| Sep 15 | APEX clinical update | Positive | +1.1% | New APEX data showing >50% achieving ≥15-letter gains and rapid drying. |
| May 13 | GLOW2 trial initiation | Positive | +0.3% | First patients treated in Phase 3 GLOW2 after strong GLOW1 DR results. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial updates have produced modest stock reactions, with a mix of small gains and one mild selloff despite generally positive data.
Recent history for Kodiak centers on retinal clinical progress. Prior APEX updates for KSI-101 in MESI on Sep 15, 2025 and Nov 5, 2025 highlighted strong vision gains and retinal drying, yet share moves stayed modest (from -1.49% to +1.08%). Earlier, on May 13, 2024, initiation of the Phase 3 GLOW2 study for tarcocimab in diabetic retinopathy also saw only a small reaction. Today’s end-of-study APEX results continue this pattern of steady clinical strengthening rather than dramatic trading shifts.
Key Terms
macular edema medical
uveitis medical
bispecific trap-antibody medical
interleukin-6 medical
vascular endothelial growth factor medical
phase 1b medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Dr. Sumit Sharma, retina and uveitis specialist at the Cole Eye Institute, will present first-time end-of-study clinical results, including Week 24 data, from the Phase 1b APEX study in patients with macular edema secondary to inflammation (MESI).
- Presentation title: Bispecific Trap-antibody Inhibiting Interleukin-6 and Vascular Endothelial Growth Factor (KSI-101): Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation (MESI)
- Time: 5:15 PM EST
The presentation will be posted at the start of the event on the "Events and Presentations" section of Kodiak's website at http://ir.kodiak.com/.
"This year's Angiogenesis meeting marks the first presentation of end-of-study results from the APEX study for KSI-101. These final data continue to demonstrate robust anatomic and visual improvements in patients with MESI, regardless of the underlying etiology or location of inflammation, further supporting the clinical efficacy and safety profile of KSI-101 observed to date. With PEAK and PINNACLE Phase 3 studies actively enrolling, these final results strengthen our confidence in KSI-101's potential to become a safe, first-line unifying therapy for all causes of MESI," said Victor Perlroth, M.D., Chairman and CEO of Kodiak Sciences.
About KSI-101
KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF. We are developing KSI-101 for patients with macular edema (retinal fluid) secondary to inflammation (MESI). MESI is a heterogenous group of diseases that clinically present with macular edema and visual impairment which are caused by a common pathophysiology–inflammation and blood retinal barrier disruption. The clinical presentation of retinal fluid and visual impairment is a mainstay in these patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (defined autoimmune associated, idiopathic, post-procedural, or inflammatory choroidal neovascularization).
Currently there are no available intravitreal biologic therapies addressing the spectrum of MESI diseases. We believe that MESI represents a new market segment separate from the established anti-VEGF market.
We have completed enrollment in our dose-finding Phase 1b study APEX. The APEX study evaluates KSI-101 in two cohorts, Cohort 1 in patients with diabetic macular edema (DME) and Cohort 2 in patients with macular edema secondary to inflammation (MESI). APEX demonstrated that KSI-101 provides meaningful visual and anatomical gains in both DME and MESI and that KSI-101 is well tolerated. Meaningful treatment responses were seen in the MESI population, irrespective of the location of inflammation and specific MESI etiology, opening up the potential for KSI-101 to become a unifying treatment for this patient population.
Based on APEX, the top two dose levels tested were selected to advance into the Phase 3 program. The PEAK and PINNACLE Phase 3 studies are actively enrolling MESI subjects at the 5 mg and 10 mg dose levels versus sham.
About Kodiak Sciences Inc.
Kodiak Sciences (Nasdaq: KOD) is a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. We are developing a portfolio of three late-stage clinical programs. Tarcocimab and KSI-501 are being explored in two BLA-facing Phase 3 studies in the retinal vascular diseases, targeting the
Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.
Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Kodiak's plans, commitments, aspirations and goals related to Kodiak's drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled "Risk Factors" in Kodiak's most recent periodic report filed with the U.S. Securities and Exchange Commission ("SEC") as well as discussions of potential risks, uncertainties, and other important factors in Kodiak's subsequent filings with the SEC. All information in this press release is as of the date presented, and Kodiak undertakes no duty to update such information unless required by law.
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SOURCE Kodiak Sciences Inc.