Follow-up data for Kodiak's KSI-101 from the APEX study showed continued strengthening of clinical effect (≥90% of patients achieving absence of intraretinal and subretinal fluid) through week 20 in macular edema secondary to inflammation (MESI)
Kodiak (Nasdaq: KOD) reported Week 20 follow-up data from the Phase 1b APEX study of KSI-101 in macular edema secondary to inflammation (MESI) on Nov 5, 2025. Key results: ≥90% of patients in the top two dose levels (5 mg, 10 mg) achieved and sustained absence of intraretinal and subretinal fluid; mean BCVA gains from baseline to Week 20 were +13.4 letters (5 mg) and +15.4 letters (10 mg); proportions with ≥15-letter gain were 62% (5 mg) and 54% (10 mg). Mean OCT CST reductions were up to -230.1 microns. KSI-101 was described as well tolerated and the top two doses are advancing into the actively enrolling Phase 3 PEAK and PINNACLE studies.
Kodiak (Nasdaq: KOD) ha riportato dati di follow-up della Settimana 20 dallo studio di fase 1b APEX di KSI-101 in edema maculare secondario a infiammazione (MESI) il 5 novembre 2025. Risultati chiave: ≥90% dei pazienti nei due livelli di dose superiori (5 mg, 10 mg) hanno ottenuto e mantenuto l'assenza di liquido intraretinico e subretinino; i guadagni medi di BCVA rispetto al basale fino alla Settimana 20 sono stati +13.4 lettere (5 mg) e +15.4 lettere (10 mg); le proporzioni con guadagno ≥15 lettere sono state 62% (5 mg) e 54% (10 mg). Le riduzioni medie di OCT CST sono state fino a -230.1 micron. KSI-101 è stato descritto come ben tollerato e le due dosi superiori stanno avanzando negli studi di fase 3 PEAK e PINNACLE in enrollement attivo.
Kodiak (Nasdaq: KOD) informó datos de seguimiento de la Semana 20 del estudio de fase 1b APEX de KSI-101 en edema macular secundario a inflamación (MESI) el 5 de noviembre de 2025. Resultados clave: ≥90% de los pacientes en los dos niveles de dosis superiores (5 mg, 10 mg) lograron y mantuvieron la ausencia de líquido intrarretiniano y subretiniano; las ganancias medias de BCVA desde la línea de base hasta la Semana 20 fueron +13.4 letras (5 mg) y +15.4 letras (10 mg); las proporciones con ganancia ≥15 letras fueron 62% (5 mg) y 54% (10 mg). Las reducciones medias de OCT CST fueron de hasta -230.1 micras. KSI-101 fue descrito como bien tolerado y las dos dosis superiores avanzan a los estudios de Fase 3 PEAK y PINNACLE que están reclutando activamente.
Kodiak (Nasdaq: KOD) 2025년 11월 5일에 망막염 주된 염증(MESI)으로 인한 황반부 edema에 대한 KSI-101의 1b상 APEX 연구의 20주 추적 데이터를 발표했습니다. 주요 결과: 상위 두 용량 수준(5 mg, 10 mg)에서 ≥90%의 환자가 망막내 및 망막하액의 부재를 달성하고 유지했습니다; 기저선 대비 주 20까지의 평균 BCVA 증가치는 +13.4 글자(5 mg) 및 +15.4 글자(10 mg)였고; ≥15 글자 이득의 비율은 62%(5 mg) 및 54%(10 mg)였습니다. 평균 OCT CST 감소는 최대 -230.1 마이크로미터였습니다. KSI-101은 내약성이 양호한 것으로 설명되었고 상위 두 용량은 활발히 등록 중인 3상 PEAK 및 PINNACLE 연구로 진행 중입니다.
Kodiak (Nasdaq: KOD) a publié le 5 novembre 2025 les données de suivi de la semaine 20 de l'essai de phase 1b APEX de KSI-101 dans l'œdème maculaire secondaire à une inflammation (MESI). Résultats clés : ≥90% des patients des deux niveaux de dose supérieurs (5 mg, 10 mg) ont atteint et maintenu l'absence de fluide intrarétinien et sous-rétinien; les gains moyens de BCVA depuis la baseline jusqu’à la semaine 20 étaient +13,4 lettres (5 mg) et +15,4 lettres (10 mg); les proportions avec un gain ≥15 lettres étaient 62% (5 mg) et 54% (10 mg). Des réductions moyennes du CST OCT allant jusqu'à -230,1 microns. KSI-101 a été décrit comme bien toléré et les deux doses les plus élevées progressent vers les études de phase 3 PEAK et PINNACLE, en recrutement actif.
Kodiak (Nasdaq: KOD) meldete am 5. November 2025 Follow-up-Daten der Woche 20 aus der Phase-1b-APEX-Studie von KSI-101 bei Makulaödem infolge Entzündung (MESI). Zentrale Ergebnisse: ≥90% der Patienten auf den beiden höchsten Dosierungsstufen (5 mg, 10 mg) erreichten und hielten das Fehlen von intraretinaler und subretinaler Flüssigkeit; mittlere BCVA-Gewinne vom Ausgangswert bis Woche 20 betrugen +13,4 Buchstaben (5 mg) und +15,4 Buchstaben (10 mg); Anteile mit ≥15 Buchstaben Gewinn betrugen 62% (5 mg) und 54% (10 mg). Mittlere OCT-CST-Reduktionen lagen bei bis zu -230,1 Mikrometer. KSI-101 wurde als gut verträglich beschrieben und die beiden Höchstdosen schreiten in die aktiv rekrutierenden Phase-3-Studien PEAK und PINNACLE voran.
Kodiak (Nasdaq: KOD) أبلغت في 5 نوفمبر 2025 عن بيانات المتابعة للأسبوع 20 من دراسة المرحلة 1b APEX لـ KSI-101 في الوذمة البuagية المرتبطة بالالتهاب (MESI). النتائج الرئيسية: ≥90% من المرضى في مستويي الجرعة الأعلىين (5 mg, 10 mg) حققوا وحققوا فقدان السوائل داخل الشبكية وخارجها واحتفظوا به؛ الارتفاعات المتوسطة في BCVA من خط الأساس حتى الأسبوع 20 كانت +13.4 حروف (5 mg) و +15.4 حروف (10 mg); النسب ذات الربح ≥15 حرفًا كانت 62% (5 mg) و 54% (10 mg). الانخفاضات المتوسطة في OCT CST كانت حتى -230.1 ميكرون. وُصف KSI-101 بأنه جيد التحمل وتستمر الجرعتان الأعلى في الانتقال إلى دراسات المرحلة 3 PEAK و PINNACLE التي تجري حالياً إجراءات التوظيف بنشاط.
- ≥90% real retinal dryness in top two dose levels
- +15.4 ETDRS letters mean BCVA gain at 10 mg (Week 20)
- Mean OCT CST reduction of -230.1 microns at 10 mg
- Top two doses (5 mg, 10 mg) advanced into active Phase 3 PEAK and PINNACLE
- Small sample size: n=13 patients per dose cohort
- Week 20 Phase 1b results require Phase 3 confirmation before clinical adoption
Insights
Kodiak's KSI-101 shows robust Week 20 efficacy and retinal drying in Phase 1b; Phase 3 studies are actively enrolling.
Kodiak demonstrates strong early and sustained clinical signal for KSI-101 in macular edema secondary to inflammation (MESI). The APEX Phase 1b Week 20 data report mean BCVA gains of +11.8 to +15.4 ETDRS letters across dose levels, >50% of patients in the 5 mg and 10 mg arms achieved ≥15-letter gains, and the top two dose levels achieved and sustained retinal dryness in
The clinical mechanism combines IL-6 and VEGF inhibition, which the data link to rapid onset of anatomical drying by Week 1 and continued functional gains through Week 20. Risks and dependencies include small cohort sizes (n=13 per dose), absence of comparative or statistical testing in the disclosed data, and the need for Phase 3 confirmation to generalize safety and efficacy. Safety is described as favorable but lacks granular adverse event rates in the release.
Key items to watch are topline Phase 3 readouts and any Week 24 APEX presentation at the Angiogenesis, Exudation, and Degeneration meeting on
- Meaningful vision gains are rapidly achieved as early as week 4 and showed continued improvement in best corrected visual acuity (BCVA) through week 20, with more than half of patients achieving improvement of 3-lines or more on the eye chart (≥15 letter gain).
- ≥
90% of patients in the top two dose levels achieved and sustained real dryness of the retina, as demonstrated by absence of intraretinal fluid (IRF) as well as subretinal fluid (SRF), key markers of disease activity. - The Phase 3 PEAK and PINNACLE studies of KSI-101 are enrolling at a faster-than-expected pace, evaluating the top two dose levels (5 mg and 10 mg) in patients with MESI.
MESI is a heterogenous group of serious vision threatening retinal diseases that clinically present with macular edema (retinal fluid) and visual impairment, caused by a common pathophysiology of inflammation and blood retinal barrier disruption. Existing therapies remain limited by side effects and tolerability, underscoring the need for safer and more effective treatment options.
KSI-101 is novel, potent and high strength (100 mg/mL) antibody-based investigational therapy with a bispecific mechanism of action targeting both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF).
Week 20 Data Highlights from Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation – Baseline to Week 20 (Patients dosed at Weeks 0, 4, 8 and 12)
|
|
Dose Level |
||
|
|
2.5 mg n=13 Patients |
5 mg n=13 Patients |
10 mg n=13 Patients |
|
Proportion of Patients with ≥15 Letter Gain |
38 % |
62 % |
54 % |
|
Mean Change in Best Corrected Visual Acuity (BCVA) from Baseline to Week 20 (ETDRS Letters) |
+11.8 |
+13.4 |
+15.4 |
|
Mean BCVA Score achieved at Week 20 (ETDRS Letters; Snellen equivalent) |
74.5 ~20/32 |
79.1 ~20/25 |
79.0 ~20/25 |
|
Mean Change in Retinal Thickness (Ocular Coherence Tomography Central Subfield Thickness) from Baseline to Week 20 (microns) |
-151.2 |
-218.1 |
-230.1 |
|
Mean OCT CST achieved at Week 20 (microns) |
310.5 |
269.2 |
296.2 |
KSI-101 continued to be well tolerated with a favorable safety profile.
Dr. Victor Perlroth, M.D., Chairman and CEO of Kodiak 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. Most importantly, we can achieve this with a safe profile. We believe that, if confirmed in our Phase 3 studies PEAK and PINNACLE, KSI-101 may harmonize the MESI therapeutic landscape by becoming a safe, first-line unifying therapy for all causes of MESI."
"At the recent American Academy of Ophthalmology meetings, intraocular interleukin-6 inhibition was shown in Phase 3 clinical trials to deliver a meaningful improvement in vision and anatomy in patients with uveitic macular edema, a key component of MESI. Local IL-6 inhibition also appeared to be well tolerated in these trials. At the same time, there appears to be a significant opportunity for KSI-101, a potent inhibitor of interleukin-6 that layers on potent inhibition of VEGF, to drive a stronger clinical effect," continued Dr. Perlroth. "We believe KSI-101 has the potential to achieve best-in-class efficacy for patients with macular edema secondary to inflammation."
Dr. Velazquez-Martin, M.D., Chief Medical Officer of Kodiak commented. "It is reassuring to see the APEX Week 20 data further validate our own thinking of KSI-101 as a transformative therapy. Two key aspects of the extended data are very compelling and support our selection of the top two KSI-101 dose levels tested to move forward into our Phase 3 program: achieving and sustaining real dryness as defined by absence of intraretinal and subretinal fluid in more than ≥
Once completed, the results including Week 24 data will be presented by Dr. Sumit Sharma, M.D., retina and uveitis specialist at the Cleveland Clinic's Cole Eye Institute, on February 7th, 2026, at the Angiogenesis, Exudation, and Degeneration 2026 Annual Meeting.
The top two dose levels in APEX, KSI-101 5 mg and 10 mg have been advanced into the Phase 3 pivotal studies PEAK and PINNACLE. The PEAK and PINNACLE Studies are actively enrolling.
Week 20 follow-up results from the APEX study have been posted on the "Events and Presentations" page of Kodiak.com located here: https://ir.kodiak.com/events-and-presentations/events
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 PEAK and PINNACLE
The PEAK and PINNACLE studies are superiority studies evaluating two dose levels of KSI-101 (5 mg and 10 mg) compared to sham treatment in patients with MESI. PEAK and PINNACLE are identical in study design with key differences in patient population. PEAK includes patients with more severe disease (moderate to severe macular edema and vision impairment) and PINNACLE includes patients with milder disease (mild macular edema and any vision impairment), as well as patients with moderate to severe macular edema with good vision. Together, PEAK and PINNACLE are designed to enroll complementary patient populations and to cover a wide spectrum of MESI patients.
Patients randomized to the KSI-101 treatment arms will receive fixed monthly dosing for 6 doses (from Day 1 to Week 20), with subsequent individualized dosing (up to monthly dosing) for 6 additional visits (Week 24 to Week 44). Patients in the sham arm will receive monthly sham dosing for 6 doses followed by sham PRN.
The primary and key secondary endpoints will be evaluated at Week 24. PEAK and PINNACLE are now actively enrolling patients. Additional information about PEAK and PINNACLE can be found on www.clinicaltrials.gov under Trial Identifiers NCT06990399 and NCT06996080, respectively (https://clinicaltrials.gov/study/NCT06990399; https://clinicaltrials.gov/study/NCT06996080).
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. Our ABC® Platform uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. 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
For more information, please visit www.kodiak.com.
Kodiak®, Kodiak Sciences®, ABC®, ABC Platform®, ABCD™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: the potential for KSI-101 to fully dry the retina, achieve meaningful visual acuity gains and normalize visual acuity with a safe profile, the potential for KSI-101 to have a stronger clinical effect as a bispecific inhibitor of IL-6 and VEGF than individual inhibitors of Il-6 alone, and to possibly become a cornerstone or unifying treatment for the MESI patient population; the size of the anti-VEGF marketplace, expected topline data readouts in 1Q 2026 and 3Q 2026 for tarcocimab and KSI-501, the MESI market opportunity and the expected topline data readouts in 4Q 2026 or 1Q 2027 for KSI-101. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "could," "expect," "plan," "believe," "intend," "pursue," and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that cessation, modification or delay of any of the ongoing clinical studies may occur; the risk that our research and development efforts and our ability to advance our product candidates into later stages of development may fail; the risk that any one or more of our product candidates may not be successfully developed, approved or commercialized; the risk that adverse economic conditions may significantly impact our business and operations, including our clinical trial sites, and those of our manufacturers, contract research organizations or others with whom we conduct business; the risk that sufficient capital may not be available as expected, or at all, to complete the development of any products; as well as the other risks identified in our filings with the Securities and Exchange Commission (SEC). For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
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FAQ
What Week 20 visual acuity gains did Kodiak report for KSI-101 (KOD)?
How many KSI-101 patients achieved complete retinal drying in the APEX study?
What proportion of APEX patients on KSI-101 (KOD) achieved ≥15-letter improvement by Week 20?
Did Kodiak report safety concerns for KSI-101 in the APEX Week 20 data?
Are the Phase 3 studies for KSI-101 enrolling and which doses are being tested?
Where and when will additional APEX results be presented for KSI-101 (KOD)?
