PALO ALTO, Calif., Oct. 11, 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 promising safety,
efficacy and durability data from its ongoing Phase 1b study of its investigational therapy KSI-301
in patients with treatment-naïve wet age-related macular
degeneration (AMD), diabetic macular edema (DME) and retinal vein
occlusion (RVO).
The results were presented by Charles C.
Wykoff, M.D, Ph.D., a clinical investigator in the study, as
an oral presentation at the "First-Time Results of Clinical Trials"
session of the American Academy of Ophthalmology Annual Meeting's
Retina Subspecialty Day. Dr. Wykoff is Director of Research at
Retina Consultants of Houston. The
study findings presented today by Dr. Wykoff can be found on the
Kodiak Investor Relations website at http://ir.kodiak.com.
"We continue to observe encouraging safety and efficacy data in
the Phase 1b study of KSI-301, and
the emerging durability data are remarkable," said Jason Ehrlich, M.D., Ph.D., Chief Medical
Officer of Kodiak Sciences. "In wet AMD, a next-generation
intravitreal biologic would bring nearly all patients to a three
month or longer dose interval. Our early data suggest this is
achievable using KSI-301, with 87% of wet AMD patients extending
beyond three months after the last loading dose without receiving
retreatment. In DME, a pan-retinal disease that typically has a
high initial treatment burden, we observed that 82% of patients
were extended beyond three months without receiving retreatment
following only three initial loading doses. Further, we are seeing
promising early signs of improvement in diabetic retinopathy, with
40% of patients improving in diabetic retinopathy severity level
within the first twelve weeks of treatment and no patients
worsening. In RVO, a disease which typically requires monthly
anti-VEGF therapy to achieve the best results, we observed that
over half the patients were extended beyond three months after only
three loading doses without receiving retreatment and over a
quarter of patients received their first retreatment at two months.
Interestingly, we also see potential signs of disease modification
in RVO as evidenced by a sequentially increased time to retreatment
in patients who have received more than one retreatment to
date."
"These new results reinforce our belief in the potential for
KSI-301 to reduce treatment burden and improve vision outcomes for
patients. To that end, we are designing pivotal studies to
demonstrate meaningful differentiation of KSI-301 in each of the
retinal vascular diseases," said Victor
Perlroth, M.D., Chief Executive Officer of Kodiak Sciences.
"We have begun dosing patients in our DAZZLE pivotal study of
KSI-301 in wet AMD, where KSI-301 will be given on an every three-,
four- or five-month dosing interval. We look forward to discussing
our accelerating plans for the clinical development of KSI-301 at
our R&D Day on Monday, October
14."
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 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 study is expected to
enroll at least 368 patients worldwide. 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 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 reduce treatment burden and improve vision
outcomes, including its potential to bring patients to a three
month or longer dose interval, 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
1b 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.