New data for Kodiak's KSI-101 from the APEX study reinforce its clinically meaningful vision gains and rapid retinal drying in macular edema secondary to inflammation (MESI)
Kodiak Sciences (NASDAQ:KOD) has presented new data from their Phase 1b APEX study of KSI-101, a novel bispecific antibody therapy targeting IL-6 and VEGF for treating macular edema secondary to inflammation (MESI). The data shows significant vision improvements, with over 50% of patients in the top two dose levels (5mg and 10mg) achieving ≥15 letter gains.
Key results include mean vision gains of 8.8 to 12.1 letters across dose levels and substantial retinal thickness reductions of 165-240 microns at Week 12. The therapy demonstrated rapid onset, with the majority of patients achieving retinal dryness by Week 8. A separate cohort of diabetic macular edema patients showed 12.0 letter gains at Week 24.
The company is now advancing Phase 3 PEAK and PINNACLE studies testing the 5mg and 10mg doses, with KSI-101 showing a favorable safety profile across all patient groups.
Kodiak Sciences (NASDAQ:KOD) ha presentato nuovi dati dal loro studio di fase 1b APEX su KSI-101, una nuova terapia con anticorpo bispecifico mirata a IL-6 e VEGF per il trattamento dell'edema maculare secondario all'infiammazione (MESI). I dati mostrano miglioramenti significativi della vista, con oltre il 50% dei pazienti nei due dosaggi superiori (5 mg e 10 mg) che hanno ottenuto guadagni ≥15 lettere.
Risultati chiave includono guadagni medi di vista da 8,8 a 12,1 lettere su vari livelli di dosaggio e sostanziali riduzioni dello spessore retinico di 165-240 micron alla settimana 12. La terapia ha mostrato un inizio d'azione rapido, con la maggioranza dei pazienti che ha raggiunto la secchezza retinale entro la settimana 8. Una coorte separata di pazienti con edema maculare diabetico ha mostrato guadagni di 12,0 lettere alla settimana 24.
L'azienda sta ora avanzando negli studi di fase 3 PEAK e PINNACLE valutando le dosi di 5 mg e 10 mg, con KSI-101 che mostra un profilo di sicurezza favorevole in tutti i gruppi di pazienti.
Kodiak Sciences (NASDAQ:KOD) ha presentado nuevos datos del estudio de Fase 1b APEX de su fármaco KSI-101, una nueva terapia con anticuerpo bispecifico que apunta a IL-6 y VEGF para tratar el edema macular secundario a inflamación (MESI). Los datos muestran mejoras significativas de la visión, con más del 50% de los pacientes en las dos dosis más altas (5 mg y 10 mg) logrando ganancias de ≥15 letras.
Resultados clave incluyen ganancias medias de visión de 8,8 a 12,1 letras a través de las dosis y reducciones sustanciales del grosor retiniano de 165-240 micras en la Semana 12. La terapia mostró un inicio rápido, con la mayoría de los pacientes alcanzando sequedad retiniana para la Semana 8. Una cohorte separada de pacientes con edema macular diabético mostró ganancias de 12,0 letras en la Semana 24.
La compañía avanza ahora en los estudios de Fase 3 PEAK y PINNACLE evaluando las dosis de 5 mg y 10 mg, con KSI-101 mostrando un perfil de seguridad favorable en todos los grupos de pacientes.
Kodiak Sciences (NASDAQ:KOD)가 KSI-101를 대상으로 한 제1b상 APEX 연구의 새로운 데이터를 발표했습니다. IL-6와 VEGF를 표적으로 하는 망막염 증후군(MESI)을 치료하기 위한 새로운 이중 특이 항체 치료제입니다. 데이터는 유의미한 시력 개선을 보여주며, 상위 두 용량군(5mg 및 10mg)에서 환자의 50% 이상이 ≥15 글자 증가를 달성했습니다.
주요 결과로는 용량 평군 시력 증가 8.8~12.1글자가 다양한 용량 수준에서 나타났고, 주 12에 망막 두께가 165-240마이크로미터 감소하는 등 망막 두께 감소가 크게 나타났습니다. 치료는 시작 속도가 빠르며, 대다수의 환자가 8주 차에 망막 건조를 달성했습니다. 당뇨성 황반부종 환자 한 코호트에서는 주 24에 12.0 글자 증가를 보였습니다.
회사는 이제 5mg 및 10mg 용량을 평가하는 3상 PEAK 및 PINNACLE 연구를 진행 중이며, KSI-101은 모든 환자군에서 우수한 안전성을 보였습니다.
Kodiak Sciences (NASDAQ:KOD) a présenté de nouvelles données de son essai de phase 1b APEX sur KSI-101, une nouvelle thérapie par anticorps bispécifique ciblant IL-6 et VEGF pour le traitement de l’œdème maculaire secondaire à l’inflammation (MESI). Les données montrent des améliorations significatives de la vision, avec plus de 50% des patients dans les deux niveaux posologiques supérieurs (5 mg et 10 mg) obtenant des gains ≥15 lettres.
Résultats clés: gains moyens de vision de 8,8 à 12,1 lettres sur les différents niveaux de dose et des réductions substantielles de l’épaisseur rétinienne de 165-240 microns à la semaine 12. Le traitement a montré un début d’action rapide, la majorité des patients atteignant la sécheresse rétinienne à la semaine 8. Une cohorte distincte de patients atteints d’oedème maculaire diabétique a montré des gains de 12,0 lettres à la semaine 24.
La société progresse désormais dans les études de phase 3 PEAK et PINNACLE évaluant les doses de 5 mg et 10 mg, KSI-101 présentant un profil de sécurité favorable dans tous les groupes de patients.
Kodiak Sciences (NASDAQ:KOD) hat neue Daten aus der Phase-1b-APEX-Studie zu KSI-101, einer neuen bispezifischen Antikörpertherapie, die IL-6 und VEGF anspricht, zur Behandlung von Makulaödem infolge Entzündung (MESI) vorgestellt. Die Daten zeigen signifikante Sehverbesserungen, wobei über 50% der Patienten in den beiden oberen Dosierungsniveaus (5 mg und 10 mg) ≥15 Buchstaben gewinnen.
Wichtige Ergebnisse umfassen durchschnittliche Sehverbesserungen von 8,8 bis 12,1 Buchstaben über die Dosierungsstufen hinweg und erhebliche Reduktionen der Netzhautdicke von 165–240 Mikrometern in Woche 12. Die Therapie zeigte einen raschen Wirkeinfluss, wobei die Mehrheit der Patienten bis Woche 8 eine Netzhauttrockenheit erreichte. Eine separate Kohorte von Patienten mit diabetischem Makulaödem zeigte 12,0 Buchstaben Gewinn in Woche 24.
Das Unternehmen treibt nun die Phase-3-Studien PEAK und PINNACLE voran, die die Dosen 5 mg und 10 mg testen, wobei KSI-101 ein günstiges Sicherheitsprofil in allen Patientengruppen aufweist.
Kodiak Sciences (NASDAQ:KOD) قدمت بيانات جديدة من تجربة المرحلة 1b APEX لـ KSI-101، وهو علاج جديد بجسم مضاد ثنائي الهدف IL-6 وVEGF لعلاج الوذمة البقعية الثانوية إلى الالتهاب (MESI). البيانات تُظهر تحسينات كبيرة في الرؤية، حيث حقق أكثر من 50% من المرضى في المستويين الأعلى للجرعات (5 ملغ و10 ملغ) زيادات بمقدار ≥15 حرفًا.
تشمل النتائج الرئيسية زيادات متوسطة في الرؤية من 8.8 إلى 12.1 حرفًا عبر مستويات الجرعات وخصائص انخفاض سُمك الشبكية بشكل كبير من 165-240 ميكرون في الأسبوع 12. أظهرت المعالجة بداية سريعة للفعالية، حيث حقق غالبية المرضى جفاف الشبكية بحلول الأسبوع 8. كما أظهرت مجموعة فرعية من مرضى وذمة النقرة السكرية زيادة بمقدار 12.0 حرفًا في الأسبوع 24.
تواصل الشركة الآن التقدم في دراسات المرحلة 3 PEAK و PINNACLE لاختبار الجرعات 5 ملغ و10 ملغ، مع عودة KSI-101 بملف أمان مفضل عبر جميع مجموعات المرضى.
Kodiak Sciences (NASDAQ:KOD) 已公布其阶段1b APEX 研究中对 KSI-101 的新数据，该药是一种针对 IL-6 和 VEGF 的双特异性抗体治疗，用于治疗炎症相关的黄斑水肿（MESI）。数据表明出现了< b>显著的视力改善，在前两种剂量水平（5 mg 和 10 mg）中，超过 50% 的患者实现了 ≥15 个字母的增益。
关键结果包括在各剂量水平上出现的< b>平均视力增益为 8.8 至 12.1 字母，以及第 12 周视网膜厚度显著下降 165-240 微米。治疗显示出快速起效，绝大多数患者在第 8 周达到视网膜干燥。另一组糖尿病性黄斑水肿患者在第 24 周显示出< b>12.0 字母增益。
公司现正推进 Phase 3 PEAK 与 PINNACLE 研究，评估 5 mg 与 10 mg 剂量，KSI-101 在所有患者组别中显示出有利的安全性特征。
- Strong efficacy with >50% of patients achieving ≥15 letter vision gains in top two dose levels
- Rapid onset of action with majority achieving retinal dryness by Week 8
- Favorable safety profile allowing highest dose levels (5mg and 10mg) to advance to Phase 3
- Broad activity across different types of MESI patients
- Promising results in separate DME cohort with 12.0 letter gains at Week 24
- Still in early development phase with Phase 3 trials ongoing
- No approved treatment currently exists for MESI, indicating regulatory pathway uncertainty
Insights
Kodiak's KSI-101 shows strong efficacy in MESI patients with significant vision improvements and rapid retinal drying, potentially transforming treatment for this underserved condition.
The latest data from Kodiak's Phase 1b APEX study demonstrates compelling clinical benefits for KSI-101 in treating macular edema secondary to inflammation (MESI). The results show a dose-dependent response across the three tested concentrations (2.5mg, 5mg, and 10mg), with the highest dose achieving an impressive +12.1 letter improvement in vision at 12 weeks. Most notably, over 50% of patients in the higher dose groups (5mg and 10mg) achieved clinically meaningful vision gains of 15 letters or more - equivalent to 3 lines on an eye chart.
The drug's rapid onset of action is particularly striking, with benefits seen as early as 4 weeks and >90% of patients achieving retinal dryness by week 8. This indicates KSI-101's powerful ability to resolve intra-retinal and sub-retinal fluid, a key marker of disease control. The bispecific mechanism targeting both IL-6 and VEGF appears to address the dual pathways driving MESI more effectively than current options.
What's especially significant is the comparison made by Dr. Sharma to Ozurdex (dexamethasone implant), suggesting KSI-101 provides similar or better retinal drying but without the side effects typically associated with steroids (which can include cataract formation and intraocular pressure elevation). For MESI patients, who currently lack good treatment options, this represents a potential paradigm shift.
The drug also showed efficacy in diabetic macular edema (DME) patients, with +12.0 letter gains and -157 micron reduction in retinal thickness at 24 weeks, suggesting broader applications. The favorable safety profile and the company's decision to advance the two highest doses to Phase 3 trials (PEAK and PINNACLE) indicate confidence in both efficacy and tolerability.
- Meaningful vision gains are rapidly achieved as early as week 4 and more than half of patients in the top two dose levels improved 3-lines or more on the eye chart (≥15 letter gain)
- A single dose of KSI-101 resulted in the majority of patients achieving resolution of intra-retinal and sub-retinal fluid and over
90% of patients achieved retinal dryness by Week 8 - The Phase 3 PEAK and PINNACLE studies of KSI-101 are actively enrolling, testing the top two dose levels (5 mg and 10 mg) in patients with MESI
Dr. Charles Wykoff, MD, PhD, Deputy Chair of Ophthalmology, Blanton Eye Institute, presented continuing data from the three-arm, open-label Phase 1b APEX study of KSI-101 for the treatment of patients with macular edema secondary to inflammation (MESI), in which patients experienced a clinically meaningful gain in best-corrected visual acuity (BCVA) and rapid retinal drying from baseline to week 12.
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. No good treatment options exist today for patients with MESI.
KSI-101 is novel, potent and high strength (100 mg/mL) antibody-based investigational therapy with a bispecific mechanism of action targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF).
Data Highlights from Phase 1b APEX Study in Patients with Macular Edema Secondary to Inflammation
Dose Level | |||
2.5 mg | 5 mg | 10 mg | |
Proportion of Patients with ≥15 Letter Gain | 31 % | 62 % | 54 % |
Mean Change in Best Corrected Visual Acuity | +8.8 | +10.7 | +12.1 |
Mean Change in Retinal Thickness (Ocular Coherence Tomography Central Subfield | -165 | -216 | -240 |
In a separate cohort of patients evaluated in the APEX study, patients with diabetic macular edema (DME, n=12) demonstrated meaningful visual and anatomical gains with KSI-101, with patients gaining 12.0 letters and decreasing 157 microns in OCT CST from baseline to Week 24.
KSI-101 continued to be well tolerated with a favorable safety profile both in MESI patients and in DME patients.
Dr. Sumit Sharma, M.D., retina and uveitis specialist at the Cleveland Clinic's Cole Eye Institute, commented on the performance of KSI-101 in MESI patients. "The APEX data with KSI-101 bispecific antibody showed a drying effect that is on par with or even better than expected with the intraocular steroid implants such as Ozurdex but with none of the side effects. This is a fantastic effect and, if replicated in the ongoing Phase 3 studies, KSI-101 could significantly change how we treat the many patients with macular edema secondary to inflammation."
"It was a privilege to be able to present this new data from the APEX study at the Retina Society," said Dr. Wykoff, M.D., Ph.D., clinical investigator in the APEX study. "Although early in development, KSI-101 appears to be emerging as a powerful, dual-action, safe investigational therapy with potential applicability to a diverse set of pathologies that have relevance to retina specialists and uveitis specialists, many diseases of which currently have no approved treatment. As a retina community, we look forward to continuing our collaboration with Kodiak as they advance their portfolio of three late-stage medicines targeting a broad range of retinal diseases through their ongoing Phase 3 GLOW2, DAYBREAK, PEAK and PINNACLE studies."
Dr. Victor Perlroth, M.D., Chairman and CEO of Kodiak commented. "The continuing KSI-101 data presented by Dr. Wykoff represent the full cohort of MESI patients through Week 12. I would like to highlight the following key differentiators with KSI-101: (1) its bispecific mechanism of action, as an antibody-based inhibitor of IL-6 and a trap-based inhibitor of VEGF, (2) its rapid onset of action and powerful retinal drying effect, (3) its favorable early safety profile allowing the selection of our two highest dose levels (5mg and 10mg) for further testing in the Phase 3 program, and (4) its broad activity across the spectrum of MESI patients, irrespective of the location of the inflammation inside of the eye (anterior, intermediate, posterior or all intraocular compartments) or the specific etiology (uveitic macular edema, idiopathic macular edema, post-procedural macular edema, inflammatory choroidal neovascularization). Our focus is on the continued enrollment of patients into the PEAK and PINNACLE Phase 3 studies."
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 (uveitic macular edema, idiopathic macular edema, post-procedural macular edema, 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: KSI-101's clinically meaningful vision gains and rapid retinal drying in MESI, KSI-101's bispecific mechanism of action as an antibody-based inhibitor of IL-6 and a trap-based inhibitor of VEGF, KSI-101's favorable safety profile both in MESI patients and in DME patients, KSI-101's potential applicability to a diverse set of pathologies that have relevance to retina specialists and uveitis specialists, the advancement of the ongoing Phase 3 GLOW2, DAYBREAK, PEAK and PINNACLE studies, the continued enrollment of patients into the PEAK and PINNACLE Phase 3 studies, the potential for KSI-101 to become a 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 safety, efficacy and durability data observed in our product candidates in current or prior studies may not continue or persist; 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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