Kodiak Sciences announced the first patients have been treated in the DAZZLE pivotal study of Kodiak's anti-VEGF antibody biopolymer conjugate, KSI-301, in patients with treatment-naïve wet (neovascular) age-related macular degeneration (AMD).
"Treating the first patients in this pivotal study is an important step for Kodiak as we grow the company and accelerate our efforts with KSI-301," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "On World Sight Day, we recognize that patients with wet AMD often need frequent eye injections of an anti-VEGF medication to preserve their vision. Next generation anti-VEGF biologics are thought to support half the patients on an every two-month interval and half the patients on an every three-month interval. Using our proprietary ABC Platform™, we designed KSI-301 from the outset as a therapy with extended durability. In our DAZZLE study, we are comparing the efficacy of KSI-301 on every three-, four-, or five-month dosing versus aflibercept on its every two-month interval. We believe our dosing regimen, with all patients on every three-month dosing or better, if successful, could position KSI-301 to be a leading anti-VEGF therapy for patients with wet AMD. Early data presented last month from our ongoing Phase 1b data of KSI-301 showed the majority of wet AMD patients treated with KSI-301 reached a four- or five-month interval without receiving retreatment."
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The DAZZLE study (also called Study KSI-CL-102) is a global, multi-center, 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 study is expected to enroll at least 368 patients worldwide. The primary endpoint is at 1 year and each patient will be treated and followed for 2 years.
KSI-301 is an investigational therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (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.