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, Calif., Sept. 15, 2019 /PRNewswire/ — 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.”
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 localhos:8080.
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, future development plans, clinical and regulatory objectives and the timing thereof, anticipated design of planned clinical trials, expectations regarding the potential efficacy and commercial potential of our product candidates, including KSI-301, the anticipated presentation of data, the results of our research and development efforts and our ability to advance our product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” and other similar expressions among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the preliminary safety, efficacy and durability data for our KSI-301 product candidate from the Phase 1 study will not continue or persist; cessation or delay of any of the ongoing clinical studies and/or our development of KSI-301 may occur; future potential regulatory milestones of KSI-301, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval; anticipated presentation of data at upcoming conferences may not occur; our research and development efforts and our ability to advance our product candidates into later stages of development may fail; any one or more of our product candidates may not be successfully developed, approved or commercialized; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
“Kodiak,” “ABC Platform” and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various jurisdictions.
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