Kodiak Sciences announced promising 1-year durability, efficacy and safety data from the ongoing phase 1b study of its investigational therapy KSI-301, an intravitreal anti-VEGF antibody biopolymer conjugate, in patients with treatment-naïve wet age-related macular degeneration (AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO).
“The Year 1 data for KSI-301 presented today at Angiogenesis and the data presented on other late-stage molecules at the meeting continue to support a highly-differentiated durability profile for KSI-301 along with strong efficacy and an encouraging safety profile. We observed that two-thirds of patients in each disease cohort achieve a 6-month or longer treatment-free interval at the 1-year mark—66% of wet AMD patients, 69% of DME patients and 66% of RVO patients,” Jason Ehrlich, MD, PhD, Chief Medical Officer at Kodiak Sciences, said in a company news release. “Moreover, 78% of wet AMD patients and 84% of DME patients were on a 4-month or longer interval at Year 1, as were 75% of RVO patients. Said differently, an average of only 2.0, 1.0, and 1.7 retreatments were given in the 10 months following the three loading doses in AMD, DME, and RVO patients respectively. Remarkably, 54% of wet AMD patients required only one retreatment and 50% of DME patients required no retreatment in Year 1.”
“We are seeing strong anti-VEGF efficacy for KSI-301, when we look to historical data for anti-VEGFs and new late-stage trial data presented at today’s meeting,” continued Dr. Ehrlich. “In wet AMD, we observed a mean 5.7 letter improvement, to 69.7 ETDRS eye chart letters (~20/40 Snellen) at Year 1. In DME, we observed a mean 7.6 letter improvement to 73.9 eye chart letters (~20/32 Snellen) at Year 1, and in RVO we observed a mean 22.2 letter improvement to 76.6 letters (~20/32 Snellen). We also remain pleased with the safety profile of KSI-301, now with over 700 doses given in the Phase 1b study and over 2,000 administered across the ongoing KSI-301 clinical development program.”
“KSI-301 has the potential to become the standard of care for patients with VEGF-mediated retinal diseases,” said Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences. “Our Year 1 phase 1b data, with two in three patients achieving a 6-month or longer treatment-free interval at Year 1, show the potential for KSI-301 to provide tangible benefits for patients and retina specialists alike. The DAZZLE wet AMD study is fully recruited with an expected data read-out in early 2022, and our GLEAM and GLIMMER studies in DME and BEACON study in RVO are actively recruiting. We are grateful for the enthusiastic support of these studies from the ophthalmology community.”
The new KSI-301 data were presented online at the Angiogenesis, Exudation, and Degeneration 2021 – Virtual Edition meeting by Diana V. Do, MD, Professor of Ophthalmology and Vice Chair for Clinical Affairs at the Byers Eye Institute at Stanford University School of Medicine. The study findings presented by Dr. Do can be found on the Kodiak Investor Relations website at http://ir.kodiak.com.
About the DAZZLE Study
The phase 2b/3 DAZZLE study is a global, multicenter, randomized study designed to evaluate the durability, efficacy and safety of KSI-301 in patients with treatment-naïve wet AMD. Patients are randomized to receive either KSI-301 on an individualized dosing regimen as infrequently as every 5 months and no more often than every 3 months or to receive aflibercept on its labeled every 8-week dosing regimen, each after three monthly initiating doses. The study has enrolled over 550 patients worldwide. The primary endpoint is at 1 year, and each patient will be treated and followed for 2 years. Additional information about DAZZLE (also called Study KSI-CL-102) can be found on www.clinicaltrials.gov under Trial Identifier NCT04049266 (https://clinicaltrials.gov/show/NCT04049266).
About the GLEAM and GLIMMER Studies
The phase 3 GLEAM and GLIMMER studies are global, multicenter, randomized studies designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME). In each study, patients are randomized to receive either intravitreal KSI-301 on an individualized dosing regimen every 8 to 24 weeks after only three loading doses or intravitreal aflibercept every 8 weeks after five loading doses per its label. Each study is expected to enroll approximately 450 patients worldwide. The primary endpoint for both studies is the change from baseline in best-corrected vision at 1 year, and patients will be treated and followed for 2 years. Additional information about GLEAM (also called Study KS301P104) and GLIMMER (also called Study KS301P105) can be found on www.clinicaltrials.gov under Trial Identifiers NCT04611152 and NCT04603937, respectively (https://clinicaltrials.gov/ct2/show/NCT04611152 and https://clinicaltrials.gov/ct2/show/NCT04603937).
About the BEACON Study
The phase 3 BEACON study is a global, multicenter, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve macular edema due to retinal vein occlusion (RVO), including both branch and central subtypes. Patients are randomized to receive either intravitreal KSI-301 every 8 weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first 6 months. In the second 6 months, patients in both groups will receive treatment on an individualized basis per protocol-specified criteria. The study is expected to enroll approximately 550 patients worldwide. The primary endpoint is the change from baseline in best-corrected vision at 6 months, and patients will be treated and followed for 1 year. Additional information about the BEACON study (also called Study KS301P103) can be found on www.clinicaltrials.gov under Trial Identifier NCT04592419 (https://clinicaltrials.gov/show/NCT04592419).