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).
"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."
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 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.clinicaltrials.gov
under Trial Identifier NCT04049266
(https://clinicaltrials.gov/show/NCT04049266).
About KSI-301
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. 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.
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, but are not limited to,
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
and its ability to be a leading anti-VEGF therapy for patients with
wet AMD, 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 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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SOURCE Kodiak Sciences Inc.