Kodiak Sciences announced promising safety, efficacy, and durability 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 results were presented by Diana V. Do, MD, Professor of Ophthalmology at Byers Eye Institute, Stanford University School of Medicine, as an oral presentation at the Angiogenesis, Exudation, and Degeneration 2020 meeting in Miami. The study findings presented by Dr. Do can be found on the Kodiak Investor Relations website at http://ir.kodiak.com.
“With further maturation of the phase 1b study, the safety and efficacy of KSI-301 continue to be very encouraging, and we continue to see the potential for KSI-301 to have class-leading durability across all of the common retinal vascular diseases,” Jason Ehrlich, MD, PhD, Chief Medical Officer of Kodiak Sciences, said in a company news release. “Our belief is that a next-generation biologic should bring nearly all wet AMD and DME patients to a three month or longer dose interval and the majority of RVO patients to a 2 month or longer interval. In the data presented today at Angiogenesis, we observed that 84% of wet AMD eyes and 76% of DME eyes were extended to 4 months or longer after the last loading doses before receiving their first retreatment. Remarkably, 55% of wet AMD eyes and 64% of DME eyes were extended to 6 months. In RVO, a disease which typically requires monthly anti-VEGF therapy to achieve the best results, we continued to observe that over half the patients were extended beyond 3 months after only three loading doses and without receiving retreatment.”
“Compared to the data previously presented, more patients have been followed for longer intervals. The safety, efficacy, and durability data continue to be robust and are suggesting the potential for KSI-301 to demonstrate a novel Generation 2.0 durability profile,” Victor Perlroth, MD, Chief Executive Officer of Kodiak Sciences, said in the news release. “We are very pleased with what we continue to learn about the clinical performance of KSI-301 in this exploratory study, and we are using the data to thoughtfully design high conviction pivotal studies of KSI-301 in each of the core indications. Our DAZZLE study in wet AMD, where KSI-301 is given on an every 3-, 4-, or 5-month dosing interval, continues to recruit well. We appreciate the strong support from the ophthalmology community of patients and providers, and we look forward to initiating pivotal studies in DME, RVO, and NPDR later this year as part of our accelerating development program for KSI-301.”
KSI-301 is an investigational anti-VEGF therapy built on the company’s Antibody Biopolymer Conjugate, or ABC, Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. Kodiak’s objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The company’s DAZZLE pivotal study in patients with treatment-naïve wet AMD was initiated in October 2019. Kodiak plans to initiate additional pivotal studies of KSI-301 in 2020 in diabetic macular edema, retinal vein occlusion, and diabetic retinopathy. These studies are anticipated to form the basis of the company’s initial and supplemental BLAs to support potential approval and commercialization. KSI-301 is being developed and is fully owned globally by Kodiak Sciences Inc.
About the DAZZLE Study
The DAZZLE study (also called Study KSI-CL-102) is a global, multicenter, randomized study designed to evaluate the safety and efficacy 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 standard-care aflibercept on its every 8-week dosing regimen, each after three monthly initiating doses. The primary endpoint is at 1 year and each patient will be treated and followed for 2 years. Additional information about DAZZLE can be found on www.clinicaltrials.gov under Trial Identifier NCT04049266 (https://clinicaltrials.gov/show/NCT04049266).