PALO ALTO, Calif., Feb. 3, 2022 /PRNewswire/ -- Kodiak Sciences
Inc. (Nasdaq: KOD), a biopharmaceutical company committed to
researching, developing and commercializing transformative
therapeutics to treat high prevalence retinal diseases, today
announced that it has completed enrollment in its GLEAM and GLIMMER
Phase 3 clinical trials of KSI-301, Kodiak's anti-VEGF antibody
biopolymer conjugate, in patients with diabetic macular edema
("DME").
"Diabetic macular edema is a leading cause of vision loss in
working-age people, and the treatment burden imposed by current FDA
approved anti-VEGF therapies is challenging for many DME patients,"
said Jason Ehrlich, MD, PhD,
Kodiak's Chief Medical and Development Officer. "We are very
pleased to have completed enrollment in our GLEAM and GLIMMER
pivotal trials, where we are studying KSI-301's potential to be a
longer-lasting DME treatment – as infrequent as once every six
months. Enrollment is also proceeding well in our GLOW Phase 3
clinical trial, where we are studying every six-month dosing of
KSI-301 in non-proliferative diabetic retinopathy patients who have
not yet developed DME."
"With DAZZLE, BEACON, GLEAM and GLIMMER fully enrolled and with
DAYLIGHT recruiting quickly," said Victor
Perlroth, MD, Kodiak's Chief Executive Officer, "we have
line of sight to topline results across the full portfolio of
studies to support our single BLA submission for the three major
anti-VEGF requiring diseases of wet age-related macular
degeneration, diabetic macular edema and retinal vein occlusion. We
remain on track to announce topline results this quarter for DAZZLE
and mid-year for BEACON."
About KSI-301
KSI-301 is an investigational anti-VEGF 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 available 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 KSI-301 clinical program is designed
to assess KSI-301's durability, efficacy and safety in wet AMD,
DME, RVO and non-proliferative DR (without DME) through clinical
studies run in parallel. The Company's DAZZLE and DAYLIGHT pivotal
studies in patients with treatment-naïve wet AMD, GLEAM and GLIMMER
pivotal studies in patients with diabetic macular edema, and the
BEACON pivotal study in patients with retinal vein occlusion are
anticipated to form the basis of the Company's initial BLA to
support potential approval and commercialization in multiple
indications and with a full range of labeled and reimbursable
dosing frequencies in each indication. An additional Phase 3
pivotal study, GLOW, in patients with non-proliferative diabetic
retinopathy is also underway. The global KSI-301 clinical program
is being conducted at 150+ study sites in more than 10 countries.
Kodiak is developing KSI-301 and owns global rights to KSI-301.
About the DAZZLE Study
The Phase 2b/3 DAZZLE study is a
global, multi-center, randomized pivotal study designed to evaluate
the durability efficacy and safety 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 aflibercept on its labeled every eight-week dosing regimen,
each after three monthly initiating doses. The study has enrolled
over 550 patients worldwide. The primary endpoint is at one year,
and topline data are expected in early 2022. Each patient will be
treated and followed for two years. Additional information about
DAZZLE (also called Study KSI-CL-102) can be found on
www.clinicaltrials.gov under Trial Identifier NCT04049266
(https://clinicaltrials.gov/show/NCT04049266).
About the BEACON Study
The Phase 3 BEACON study is a global, multi-center, randomized
study designed to evaluate the durability, efficacy and safety of
KSI-301 in patients with treatment-naïve macular edema due to
retinal vein occlusion (RVO), including both branch and central
subtypes. Patients are randomized to receive either intravitreal
KSI-301 every eight weeks after only two loading doses or monthly
intravitreal aflibercept per its label, for the first six months.
In the second six months, patients in both groups will receive
treatment on an individualized basis per protocol-specified
criteria. Following this, patients can continue to receive KSI-301
for an additional six months on an individualized basis. The study
has enrolled over 550 patients worldwide. The primary endpoint is
at six months, and patients will be treated and followed for 18
months. Additional information about the BEACON study (also called
Study KS301P103) can be found on www.clinicaltrials.gov under Trial
Identifier NCT04592419
(https://clinicaltrials.gov/show/NCT04592419).
About the DAYLIGHT Study
The Phase 3 DAYLIGHT study is a global, multi-center, randomized
pivotal study designed to evaluate the efficacy and safety of
high-frequency KSI-301 in patients with treatment-naïve wet AMD.
Patients are randomized to receive either KSI-301 on a monthly
dosing regimen or to receive standard-of-care aflibercept. The
study is expected to enroll approximately 500 patients worldwide.
The primary endpoint is at ten months, and the study is being
planned and executed to allow for inclusion of its results in the
initial BLA for KSI-301 along with the DAZZLE, BEACON, GLEAM and
GLIMMER studies. The intent of this pivotal study is to broaden
KSI-301's potential product labeling, explore the potential for
improved treatment outcomes in certain patients with intensive
anti-VEGF treatment, and eliminate possible barriers to market
access and insurance reimbursement that have impeded or complicated
the commercial uptake of other anti-VEGF medications in the past.
We believe that pursuing a broad product label will provide
physicians with the flexibility, agency, and reimbursement
confidence required to consider KSI-301 treatment for all their
patients. Additional information about DAYLIGHT (also called Study
KS301P107) can be found on www.clinicaltrials.gov under Trial
Identifier NCT04964089
(https://clinicaltrials.gov/show/NCT04964089).
About the GLEAM and GLIMMER Studies
The Phase 3 GLEAM and GLIMMER studies are global, multi-center,
randomized pivotal studies designed to evaluate the durability,
efficacy and safety of KSI-301 in patients with treatment-naïve
diabetic macular edema (DME). In each study, patients are
randomized to receive either intravitreal KSI-301 on an
individualized dosing regimen every eight to 24 weeks after only
three loading doses or intravitreal aflibercept every eight weeks
after five loading doses per its label. Each study is expected to
enroll approximately 450 patients worldwide. The primary endpoint
for both studies is at one year, and patients will be treated and
followed for two years. Additional information about GLEAM (also
called Study KS301P104) and GLIMMER (also called Study KS301P105)
can be found on www.clinicaltrials.gov under Trial Identifiers
NCT04611152 and NCT04603937, respectively
(https://clinicaltrials.gov/ct2/show/NCT04611152 and
https://clinicaltrials.gov/ct2/show/NCT04603937).
About the GLOW Study
The Phase 3 GLOW study is a global, multi-center, randomized
pivotal study designed to evaluate the efficacy and safety of
KSI-301 in patients with treatment-naïve, moderately severe to
severe non-proliferative diabetic retinopathy (NPDR). Patients are
randomized to receive either KSI-301 on a once every six-month
dosing regimen after three initiating doses or to receive sham
injections. The study is expected to enroll approximately 240
patients worldwide. The primary endpoint is at one year and
patients will be treated and followed for two years. Outcomes
include changes in diabetic retinopathy severity, measured on a
standardized photographic grading scale, and the rate of
development of sight-threatening complications due to diabetic
retinopathy. Additional information about GLOW (also called Study
KS301P106) can be found on www.clinicaltrials.gov under Trial
Identifier NCT05066230
(https://clinicaltrials.gov/show/NCT05066230).
About Kodiak Sciences Inc.
Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to
researching, developing and commercializing transformative
therapeutics to treat 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, the leading cause of blindness in elderly
patients in the developed world, and diabetic eye diseases, the
leading cause of blindness in working-age patients in the developed
world. 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 the
potential for a single BLA submission in wet AMD, DME and RVO and a
supplemental BLA in NPDR; the potential for KSI-301 to obtain a
broad product label; our ability to complete patient enrollment and
announce topline data in clinical studies; future development
plans, including clinical and regulatory objectives and the timing
thereof, anticipated design of planned clinical trials, and the
anticipated presentation of data; and 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," "could,"
"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 will not continue or persist; cessation or delay of any
of the ongoing clinical studies and/or our development of KSI-301
may occur, including as a result of the ongoing COVID-19 pandemic;
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; 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, including the COVID-19
pandemic, which may significantly impact our business and
operations, including out of our headquarters in the San Francisco Bay Area and our clinical trial
sites, as well as the business or operations of our manufacturers,
contract research organizations or other third parties with whom we
conduct business; 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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