Kodiak Sciences Completes Enrollment in Second Registrational Trial of Tarcocimab in Patients with Diabetic Retinopathy
Kodiak Sciences (KOD) has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer for diabetic retinopathy (DR). The study successfully randomized over 250 patients, surpassing the enrollment target. Topline clinical data is expected in Q1 2026, following the 48-week treatment duration.
The GLOW2 design mirrors the successful GLOW1 study, with an additional loading dose for provider flexibility. This represents Kodiak's second registrational study in DR. The company plans to file a single BLA for tarcocimab covering wet AMD, DR, and RVO after receiving DAYBREAK topline data in Q2 2026.
The treatment shows promise with only 4 doses required in Year 1 and bi-annual dosing thereafter, addressing the current challenge where less than 1% of DR patients receive treatment due to the high frequency of injections required with existing therapies.
Kodiak Sciences (KOD) ha completato l'arruolamento nel suo studio clinico di fase 3 GLOW2 per il tarcocimab tedromer per la retinopatia diabetica (RD). Lo studio ha randomizzato con successo oltre 250 pazienti, superando l'obiettivo di arruolamento. I dati clinici preliminari sono attesi nel primo trimestre del 2026, dopo un periodo di trattamento di 48 settimane.
Il design di GLOW2 rispecchia lo studio GLOW1 di successo, con una dose di carico aggiuntiva per maggiore flessibilità da parte dei fornitori. Questo rappresenta il secondo studio registrativo di Kodiak per la RD. L'azienda prevede di presentare una domanda BLA unica per il tarcocimab che copra AMD umida, RD e RVO dopo aver ricevuto i dati preliminari di DAYBREAK nel secondo trimestre del 2026.
Il trattamento mostra promesse con sole 4 dosi richieste nel primo anno e somministrazioni semestrali successivamente, affrontando la sfida attuale in cui meno dell'1% dei pazienti con RD riceve trattamento a causa dell'elevata frequenza di iniezioni richieste con le terapie esistenti.
Kodiak Sciences (KOD) ha completado el reclutamiento en su ensayo clínico de fase 3 GLOW2 para el tarcocimab tedromer para retinopatía diabética (RD). El estudio ha aleatorizado con éxito a más de 250 pacientes, superando el objetivo de reclutamiento. Se esperan los datuos clínicos preliminares en el primer trimestre de 2026, tras un periodo de tratamiento de 48 semanas.
El diseño de GLOW2 refleja el exitoso estudio GLOW1, con una dosis de carga adicional para mayor flexibilidad por parte de los proveedores. Este representa el segundo estudio registral de Kodiak para la RD. La empresa planea presentar una solicitud BLA única para el tarcocimab que cubra AMD húmeda, RD y RVO después de recibir los datos preliminares de DAYBREAK en el segundo trimestre de 2026.
El tratamiento muestra promesas con solo 4 dosis requeridas en el primer año y dosificación semestral a partir de entonces, abordando el desafío actual en el que menos del 1% de los pacientes con RD reciben tratamiento debido a la alta frecuencia de inyecciones requeridas con las terapias existentes.
코디악 사이언스(KOD)는 당뇨병성 망막병증(DR)을 위한 타르코시맙 테드로머의 GLOW2 3상 임상 시험에 대한 등록을 완료했습니다. 이 연구는 250명 이상의 환자를 성공적으로 무작위 배정하여 등록 목표를 초과 달성했습니다. 주요 임상 데이터는 2026년 1분기에 48주 치료 기간 후에 예상됩니다.
GLOW2의 설계는 성공적인 GLOW1 연구를 반영하며, 제공자의 유연성을 위한 추가 로딩 용량이 있습니다. 이는 DR에 대한 코디악의 두 번째 등록 연구를 나타냅니다. 이 회사는 2026년 2분기에 DAYBREAK 주요 데이터를 받은 후 습성 AMD, DR 및 RVO를 포함하는 타르코시맙에 대한 단일 BLA를 제출할 계획입니다.
치료는 1년 차에 4회만 투여하면 되고 이후에는 반기별 투여가 필요하여, 기존 치료법으로 인해 1% 미만의 DR 환자만 치료를 받는 현재의 문제를 해결하는 데 기여하고 있습니다.
Kodiak Sciences (KOD) a terminé le recrutement dans son essai clinique de phase 3 GLOW2 pour le tarcocimab tedromer pour rétinopathie diabétique (RD). L'étude a réussi à randomiser plus de 250 patients, dépassant l'objectif de recrutement. Les données cliniques préliminaires sont attendues au premier trimestre 2026, après une durée de traitement de 48 semaines.
Le design de GLOW2 reflète l'étude GLOW1 réussie, avec une dose de charge supplémentaire pour plus de flexibilité pour les fournisseurs. Cela représente la deuxième étude d'enregistrement de Kodiak pour la RD. L'entreprise prévoit de déposer une demande BLA unique pour le tarcocimab couvrant l'AMD humide, la RD et la RVO après avoir reçu les données préliminaires de DAYBREAK au deuxième trimestre 2026.
Le traitement montre des promesses avec seulement 4 doses requises la première année et une posologie semestrielle par la suite, s'attaquant au défi actuel où moins de 1 % des patients atteints de RD reçoivent un traitement en raison de la fréquence élevée des injections requises avec les thérapies existantes.
Kodiak Sciences (KOD) hat die Rekrutierung in seiner GLOW2 Phase-3-Studie zu Tarcocimab Tedromer bei diabetischer Retinopathie (DR) abgeschlossen. Die Studie hat erfolgreich über 250 Patienten randomisiert und das Rekrutierungsziel übertroffen. Die vorläufigen klinischen Daten werden im ersten Quartal 2026 nach einer Behandlungsdauer von 48 Wochen erwartet.
Das Design von GLOW2 spiegelt die erfolgreiche GLOW1-Studie wider, mit einer zusätzlichen Lade-Dosis für mehr Flexibilität der Anbieter. Dies stellt die zweite registrierende Studie von Kodiak zur DR dar. Das Unternehmen plant, nach Erhalt der vorläufigen DAYBREAK-Daten im zweiten Quartal 2026 einen einzigen BLA für Tarcocimab einzureichen, der feuchte AMD, DR und RVO abdeckt.
Die Behandlung zeigt vielversprechende Ergebnisse mit nur 4 Dosen im ersten Jahr und halbjährlicher Dosierung danach, was das aktuelle Problem angeht, dass weniger als 1% der DR-Patienten aufgrund der hohen Injektionsfrequenz bestehender Therapien behandelt werden.
- Successful enrollment completion with over 250 patients, exceeding target
- Previous GLOW1 study met primary and all key secondary endpoints with high statistical significance
- Reduced treatment burden with only 4 doses in Year 1 and bi-annual dosing vs current frequent injection therapies
- Potential to address large untreated market (currently <1% of DR patients receive treatment)
- Long wait for trial results (Q1 2026) and regulatory filing (post Q2 2026)
- BLA filing dependent on successful outcomes of both GLOW2 and DAYBREAK trials
Insights
Kodiak's completion of enrollment in the GLOW2 Phase 3 trial represents a significant operational milestone in their clinical program for tarcocimab in diabetic retinopathy. Exceeding enrollment targets with over 250 patients indicates strong investigator interest and efficient trial execution. The mirror design to their previously successful GLOW1 study (which met primary and key secondary endpoints with high statistical significance) substantially reduces scientific risk while the addition of a loading dose enhances potential commercial profile through increased dosing flexibility.
The strategic approach of pursuing a single BLA filing for multiple indications (DR, wet AMD, and RVO) demonstrates regulatory efficiency and could maximize tarcocimab's commercial potential across retinal diseases. This milestone keeps Kodiak on track toward their regulatory strategy, with GLOW2 topline data expected in Q1 2026 and DAYBREAK data in Q2 2026.
The diabetic retinopathy market represents a substantial opportunity given current treatment penetration is below 1
The completion of GLOW2 enrollment marks important progress in addressing a critical unmet need in diabetic retinopathy management. DR is a leading cause of blindness in working-age adults, yet fewer than 1
The clinical value proposition of tarcocimab is compelling. Current standard treatments require 8-12 injections annually, creating significant barriers to treatment. GLOW1 demonstrated tarcocimab could achieve strong efficacy with only 4 doses in Year 1 followed by twice-yearly maintenance - a 6-fold reduction in treatment frequency. This dramatically reduced injection burden could transform patient adherence and willingness to initiate therapy.
From a mechanistic perspective, tarcocimab's antibody biopolymer conjugate platform appears to maintain strong biological activity while extending durability. If GLOW2 confirms the efficacy seen in GLOW1, this approach could fundamentally alter DR treatment paradigms, potentially expanding the treatable patient population by orders of magnitude. The investigator's assessment that tarcocimab could "change the treatment landscape in diabetic retinopathy and help millions of patients" aligns with the clinical profile demonstrated to date.
- Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026.
- GLOW2 study design mirrors GLOW1 study, which met primary endpoint and all key secondary endpoints with high statistical significance
"We randomized more than 250 patients into our GLOW2 Phase 3 study, exceeding our enrollment target," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak. "With its 48-week duration of treatment, all patients are expected to complete their primary endpoint visits by the end of January 2026, and we expect to announce topline clinical data in 1Q 2026."
"The GLOW2 design mirrors that of our successful GLOW1 study, with the advantage of an additional loading dose to provide dosing flexibility for providers. GLOW2 is our second registrational study in diabetic retinopathy and if there is a successful outcome, we anticipate having a regulatory package for tarcocimab that is ready to file. We remain focused on completing enrollment in our ongoing DAYBREAK Phase 3 study to broaden the efficacy profile for tarcocimab in wet age-related macular degeneration ("wet AMD"), and it is our plan to wait for DAYBREAK topline data expected in 2Q 2026 in order to file a single BLA for tarcocimab in wet AMD, DR and Retinal Vein Occlusion ("RVO")," concluded Dr. Perlroth.
Dr. Allen Hu, top enroller in the GLOW2 study and principal investigator at Cumberland Valley Retina Consultants commented on tarcocimab's potential in DR. "Fewer than
"If GLOW2 mirrors these results, I believe tarcocimab as a biologic with twice yearly dosing in all patients can change the treatment landscape in diabetic retinopathy and help millions of patients," concluded Dr. Hu.
About the Phase 3 GLOW2 Study
The Phase 3 GLOW2 study is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with diabetic retinopathy ("DR"). Patients are randomized 1:1 and receive either sham injections or tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The primary endpoint is the proportion of eyes improving ≥2 steps on Diabetic Retinopathy Severity Scale ("DRSS") from baseline at Week 48. Additional outcome measures include the proportion of eyes developing a sight threatening complication of diabetic retinopathy and the proportion of eyes improving ≥3 steps on DRSS from baseline at Week 48. Additional information about GLOW2 (also called Study KS301P108) can be found on www.clinicaltrials.gov under Trial Identifier NCT06270836 (https://clinicaltrials.gov/show/NCT06270836).
About tarcocimab tedromer (tarcocimab, KSI-301)
Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate ("ABC") Platform and is being developed as a "mainstay" intravitreal biologic monotherapy intended to provide high efficacy and high durability and a flexible 1-month through 6-month label.
To date, tarcocimab has completed three successful Phase 3 pivotal clinical studies: the Phase 3 GLOW1 study in diabetic retinopathy ("DR"), the Phase 3 BEACON study in retinal vein occlusion ("RVO") and the Phase 3 DAYLIGHT study in wet AMD. In the GLOW1 study, tarcocimab successfully treated DR patients and prevented disease progression with
Tarcocimab is currently being studied in two Phase 3 clinical trials, the GLOW2 study in diabetic retinopathy and the DAYBREAK study in wet AMD.
The GLOW2 study has a similar design as GLOW1 in which all patients randomized to investigational therapy will receive tarcocimab on extended, 6-month dosing. GLOW2 features the benefit of an additional, third monthly loading dose (baseline, Week 4, Week 8) to explore even further benefits with tarcocimab in diabetic retinopathy patients.
The DAYBREAK study includes tarcocimab in a second investigational arm against active comparator aflibercept and incorporates learnings from prior pivotal trials of tarcocimab to maximize the probability of meeting the primary endpoint of non-inferiority in visual acuity gains. Patients randomized to tarcocimab will receive individualized dosing every 4 to 24 weeks on an as needed basis following four monthly loading doses. Patients randomized to aflibercept will be dosed per its label. The individualized dosing of tarcocimab is determined by a treat-to-dryness proactive approach, using presence of retinal fluid as a disease activity marker, which resembles retina specialists' practice and optimizes each patient's treatment, instead of a combination of central subfield thickness ("CST") and vision loss. The objectives for tarcocimab in DAYBREAK are to assess its 6-month durability potential, strengthen its competitive position in wet AMD and bolster the regulatory application package for the program.
Both GLOW2 and DAYBREAK use tarcocimab's enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody that is intended to balance immediacy and durability. DAYBREAK is actively enrolling patients. Additional information about GLOW2 can be found on www.clinicaltrials.gov under Trial Identifier NCT06270836 (https://clinicaltrials.gov/study/NCT06270836). Additional information about DAYBREAK can be found on www.clinicaltrials.gov under Trial Identifier NCT06556368 (https://clinicaltrials.gov/study/NCT06556368).
About diabetic retinopathy and tarcocimab
Diabetic retinopathy is a common complication of diabetes that affects the eye. If left untreated, diabetic retinopathy progresses and eventually can lead to serious vision-threatening complications, such as diabetic macular edema and proliferative diabetic retinopathy. It is estimated that of the 36 million American adults living with diabetes, approximately 10 million have diabetic retinopathy and fewer than
Long interval dosing is particularly important in the diabetic retinopathy population, and our GLOW1 and GLOW2 studies are designed to explore the ability of tarcocimab, with all patients on an every 6-month dosing interval, to directly improve the disease (the primary endpoint) and to prevent vision threatening complications from the worsening of the disease (key secondary endpoint).
At one year, GLOW1 met its primary endpoint of the proportion of patients with at least a 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) score, a grading system measuring the degree of retinopathy. Tarcocimab achieved a 29-fold increased response rate ratio, with
GLOW1 also met all key secondary endpoints, including greater reductions in the proportion of patients developing sight-threatening complications (such as diabetic macular edema and proliferative diabetic retinopathy), versus sham, demonstrating an
After the occurrence of a sight-threatening complication, all subjects were rescued with open-label tarcocimab, where subjects received two loading doses once monthly followed by continued every 12-week dosing. In patients developing sight-threatening complications, the initial visual acuity decrease and retinal anatomy worsening were both rapidly controlled and then stabilized with every 12-week dosing of tarcocimab.
About Kodiak Sciences Inc.
Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. 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 clinical programs, two of which are late-stage today and derived from our ABC Platform and one which is platform-independent and which we believe can progress rapidly into pivotal studies.
Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases. Tarcocimab is currently being studied in two Phase 3 clinical trials, GLOW2 in patients with diabetic retinopathy and DAYBREAK in patients with wet AMD. GLOW2 enrollment is complete, and DAYBREAK is actively enrolling patients.
KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy. The Phase 3 DAYBREAK study of KSI-501 in wet AMD is actively enrolling patients.
KSI-101, our third product candidate, is a novel anti-IL-6, VEGF-trap bispecific protein. Kodiak is developing KSI-101 for the treatment of retinal inflammatory diseases, as currently there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina. The Phase 1b APEX study of KSI-101 is actively enrolling patients, as a precursor to activating the Phase 2b/3 PEAK and PINNACLE studies in patients with macular edema secondary to inflammation ("MESI").
Kodiak is advancing its platform technology to embed small molecules and other active pharmaceutical ingredients ("APIs") into Kodiak's proprietary biopolymer backbone to enable high drug-antibody-ratio ("DAR") medicines. The diverse APIs are designed to be released over time to achieve targeted, multi-specific and tailored modulation of biological pathways. The unique combination of high DAR and tailored therapeutic benefit offers potential for broad application to multifactorial diseases and builds directly from our Antibody Biopolymer Conjugate technology and its 15 years of design, development and manufacturing experience. We call this platform extension our Antibody Biopolymer Conjugate Drug ("ABCD") Platform because we are extending our platform capabilities to include the conjugation of small molecule drugs and other APIs whereas historically, we primarily conjugated biologics such as antibodies.
For more information, please visit www.kodiak.com.
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 expected timing of patients in the GLOW2 Phase 3 study completing their primary endpoint visits and announcement of topline clinical data; the anticipation of having a regulatory package for tarcocimab that is ready to file; the ability of DAYBREAK to broaden the potential efficacy profile for tarcocimab in wet AMD and complete the BLA package; the ability to complete enrollment in DAYBREAK to enable topline clinical data announcement in 2Q 2026; the plan to file a single BLA for tarcocimab in wet AMD, DR and RVO; the potential for tarcocimab to change the treatment landscape in diabetic retinopathy and help millions of patients; the probability of the DAYBREAK study meeting the primary endpoint of non-inferiority in visual acuity gains; the potential of KSI-501 to be a first-in-class bispecific ABC inhibiting VEGF and IL-6 and its potential to provide extended durability; and the potential activation of Phase 2b/3 PEAK and PINNACLE studies in patients with macular edema secondary to inflammation ("MESI"). 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," "anticipate," "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: cessation or delay of any clinical studies and/or development of tarcocimab, KSI-501 or KSI-101; the results of our ongoing studies may not provide the evidence, insights, or benefits as anticipated; the risk that safety, efficacy, and durability data observed in our product candidates in current or prior studies may not continue or persist; the risk that the results of the tarcocimab Phase 3 studies may not be sufficient to support a single BLA submission for wet AMD, DR and RVO; the risk that a BLA may not be accepted by, or receive approval from, the FDA or foreign regulatory agencies when expected, or at all; future potential regulatory milestones of tarcocimab, KSI-501 or KSI-101, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; the risk that a new formulation of tarcocimab, KSI-501 or other ABC Platform derived molecules may not provide the benefits expected; our research and development efforts and our ability to advance our product candidates into later stages of development may fail; 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; 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. Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.
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SOURCE Kodiak Sciences Inc.
FAQ
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