Late-breaking results support Kodiak’s objective of every three-, four-, and five-month long-interval dosing of KSI-301 in patients with wet AMD

KSI-301 continues towards its development goals of demonstrating safety and efficacy (with over 250 injections given to over 100 patients with no intraocular inflammation) and now promising durability data

PALO ALTO, CA, USA I September 15, 2019 I Kodiak Sciences Inc. (Nasdaq: KOD), a clinical-stage biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases, today announced emerging durability data in patients with wet age-related macular degeneration (AMD) treated in its Phase 1b clinical study of its investigational therapy KSI-301.

The results were presented by David M. Brown, M.D., FACS, an investigator in the study, as a late-breaking oral presentation at The Retina Society Annual Meeting on September 15 in London, U.K. Dr. Brown is Clinical Professor of Ophthalmology at Baylor College of Medicine, Vice-Chair for Research at the Blanton Eye Institute, Houston Methodist Hospital, and Partner at Retina Consultants of Houston, Houston, TX. The study findings presented by Dr. Brown can be found on the Kodiak Investor Relations website at http://ir.kodiak.com.

“The emerging durability data presented today suggest our objective for KSI-301 to be a leading next-generation anti-VEGF therapy with a long-interval durability profile is achievable,” said Jason Ehrlich, M.D., Ph.D., Kodiak’s Chief Medical Officer and Chief Development Officer. “In the presented cohort of treatment-naïve wet AMD patients followed for twelve weeks or longer after the loading phase, all achieved a treatment-free interval of three months or longer, with the majority reaching a four- or five-month interval and continuing to be followed without retreatment to date. While early, these durability and efficacy data, together with the continued promising safety data in over 250 injections and 100 patients, support our wet AMD ‘DAZZLE’ pivotal study design evaluating every three-, four- and five-month dosing with KSI-301. Additional details of the Phase 1b study results including durability of KSI-301 in Retinal Vein Occlusion and Diabetic Macular Edema are expected to be presented at the American Academy of Ophthalmology Retina Subspecialty Day on October 11. The DME and diabetic retinopathy severity data presented today by Dr. Brown also highlight the potential for meaningful differentiation of KSI-301 in diabetic eye disease.”

About KSI-301

KSI-301 is an investigational therapy built on Kodiak’s 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. KSI-301 is being developed and is fully owned globally by Kodiak.

About Kodiak Sciences Inc.

Kodiak™ is a clinical-stage biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases. 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™ merges the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak’s discovery engine. Kodiak’s lead product candidate, KSI-301, is a novel anti-VEGF antibody biopolymer conjugate being developed for the treatment of retinal vascular diseases including age-related macular degeneration and diabetic eye diseases. Kodiak has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development including KSI-501, our bispecific anti-IL-6/VEGF biopolymer conjugate for the treatment of neovascular retinal diseases with an inflammatory component. Kodiak is based in Palo Alto, CA. For more information, visit www.kodiak.com.

SOURCE: Kodiak Sciences