Kodiak Sciences to Host R&D Webcast to Review Recent Data from the Ongoing Phase 1b Study of KSI-301 and Highlight KSI-301 Clinical Development Progress
Kodiak Sciences Inc. (Nasdaq: KOD) announced an R&D webcast on July 27, 2020, to discuss safety, efficacy, and durability data from its ongoing Phase 1b study of KSI-301 in treating retinal diseases like wet AMD, DME, and RVO. Management will review progress on the pivotal DAZZLE study in treatment-naïve wet AMD patients and planned pivotal studies for other conditions. KSI-301 aims to improve treatment outcomes and prevent vision loss in these diseases.
- Ongoing Phase 1b study of KSI-301 showing promising safety and efficacy data.
- DAZZLE study for KSI-301 is progressing, aiming to establish a new treatment standard.
- Plans to initiate pivotal studies in additional retinal conditions like DME and RVO.
- Dependence on ongoing study results for potential regulatory approval raises uncertainty.
- Risks associated with upcoming clinical trials and their outcomes may impact timelines.
PALO ALTO, Calif., July 16, 2020 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical company specializing in novel therapeutics to treat chronic, high-prevalence retinal diseases, today announced that it will host a R&D Webcast for investors and analysts on Monday, July 27 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).
At the R&D webcast, Kodiak senior management will discuss recent safety, efficacy, and durability data from the ongoing Phase 1b study of KSI-301 in wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Management will also highlight continuing progress with the pivotal study of KSI-301 in treatment-naïve wet AMD patients (DAZZLE) and review planned pivotal studies in DME, RVO and non-proliferative diabetic retinopathy (NPDR).
A live webcast of will be available on the "Events and Presentations" section of Kodiak's website at http://ir.kodiak.com/ and will remain available for replay for a limited time following the event.
Investors, equity research analysts and others interested in participating in the Q&A portion of the event may contact ir@kodiak.com.
About 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 BLA 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, 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 five months and no more often than every three months or to receive standard-care aflibercept on its every eight-week dosing regimen, each after three monthly initiating doses. The primary endpoint is at one year and each patient will be treated and followed for two years. Additional information about DAZZLE can be found on www.clinicaltrials.gov under Trial Identifier NCT04049266 (https://clinicaltrials.gov/show/NCT04049266).
About the KSI-301 Clinical Program
The KSI-301 Clinical Program is designed to assess KSI-301's safety, efficacy and durability in wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel. We have agreed on the order and number of clinical studies required to support the licensure of KSI-301 in wet AMD, DME, RVO and non-proliferative DR at an end of phase 2 meeting with the U.S. Food and Drug Administration (FDA). We confirmed that two clinical studies conducted in a single indication are expected by FDA to demonstrate the initial safety and efficacy of KSI-301. One clinical study each in the additional disease indications, if successful, can be used to support approval in the additional indications. We intend to conduct two Phase 3 studies in DME (the GLEAM and GLIMMER studies) to provide the mutually confirmatory studies required by FDA for initial demonstration of safety and efficacy. We also intend to conduct one study in wAMD (our ongoing DAZZLE study) and one study in RVO (the BEACON study) to support approval of these additional indications. We intend to file this package together in a single BLA in 2022. We also plan to run an additional study in patients with non-proliferative DR without DME (the GLOW study) which depending on data readiness may be combined either into the single initial BLA or may be filed as a supplemental BLA. We expect that the global KSI-301 clinical program will be conducted at 100+ study sites in more than 10 countries.
About Kodiak Sciences Inc.
Kodiak (Nasdaq: KOD) is a clinical stage biopharmaceutical company developing novel therapeutics to treat chronic, high-prevalence retinal diseases. Founded in 2009, 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™ uses molecular engineering to merge 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, a leading cause of blindness in elderly patients, and diabetic retinopathy, a leading cause of blindness in working-age patients. 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, and we are expanding our early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma. Kodiak is based in Palo Alto, CA. For more information, please visit www.kodiak.com.
Forward-Looking Statements
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 future development plans and the potential licensure of KSI-301; our platform technology and potential therapies; 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; 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," "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 may 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 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®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.
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