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Kodiak Sciences Treats First Patients in DAZZLE Pivotal Study of KSI-301 in Wet Age-Related Macular Degeneration
PALO ALTO, Calif., Oct. 10, 2019 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical company specializing in novel
About this update from Kodiak Sciences Inc
[{"type":"text","content":"PALO ALTO, Calif., Oct. 10, 2019 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases, announced that 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). \n\"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.\"\nAbout the DAZZLE Study\nThe 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. Additional information about DAZZLE can be found on www.clinicaltrial...