PALO
ALTO, Calif., Aug. 5, 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 GLOW Phase 3 clinical trial of tarcocimab
tedromer (KSI-301), Kodiak's anti-VEGF antibody biopolymer
conjugate, in patients with Non-Proliferative Diabetic Retinopathy
("NPDR") without diabetic macular edema ("DME").
"Diabetic retinopathy is the leading cause of vision loss in
working-aged Americans and affects up to one third of patients with
diabetes. Right now, patients typically wait to begin anti-VEGF
treatment until they suffer a sight-threatening complication such
as diabetic macular edema or proliferative diabetic retinopathy,
partly because currently approved NPDR treatments require frequent
eye injections. Not everyone recovers their sight after we treat
these complications, so a medicine able to be given at meaningfully
longer intervals could help patients and physicians better realize
the long-recognized potential of anti-VEGF therapy as a preventive
treatment for NPDR," said Charles C.
Wykoff, MD, PhD, Director of Research, Retina Consultants of
Texas, and a GLOW Study
investigator.
"Currently approved medicines need to be injected in the eye
every month or every 2 months after 5 monthly initiating doses
which limits their utility as a preventive medicine," said
Jason Ehrlich, MD, PhD, Kodiak's
Chief Medical and Development Officer. "In our GLOW pivotal trial,
we are studying tarcocimab tedromer's potential to be dosed just
once every 6 months after a reduced density of initiating doses
given at baseline, 8 weeks, and 20 weeks into the study. We believe
tarcocimab can relieve the high treatment burden for NPDR patients,
their family members and physicians and provide an opportunity for
real prevention of vision loss among diabetic patients. We are very
grateful to the patients and physicians participating in GLOW and
the whole Kodiak team for working together to recruit the study
well ahead of schedule, and we look forward to the primary results
of the study in a year."
About Tarcocimab tedromer (KSI-301)
Tarcocimab tedromer 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 tarcocimab tedromer 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 tarcocimab
tedromer clinical program is designed to assess the product'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 GLEAM and GLIMMER pivotal studies in
patients with diabetic macular edema, the BEACON pivotal study in
patients with retinal vein occlusion, the DAYLIGHT pivotal study in
patients with wet AMD, and the GLOW study in patients with NPDR are
anticipated to form the basis of the Company's BLA to support
potential approval and commercialization in multiple indications.
The global tarcocimab tedromer clinical program is being conducted
at 150+ study sites in more than 10 countries. Kodiak is developing
and owns global rights to tarcocimab tedromer.
About the GLOW Study
The Phase 3 GLOW study is a global, multi-center, randomized
pivotal superiority study designed to evaluate the efficacy and
safety of tarcocimab tedromer in approximately 240 patients with
treatment-naïve, moderately severe to severe non-proliferative
diabetic retinopathy (NPDR). Patients are randomized to receive
either tarcocimab tedromer every six months after initiating
doses given at baseline, 8 weeks and 20 weeks into the study, or to
receive sham injections. 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. We believe tarcocimab tedromer has the potential
to be the longest-interval intravitreal therapeutic option for
patients with 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, tarcocimab
tedromer, is a novel anti-VEGF antibody biopolymer conjugate being
developed for the treatment of retinal vascular diseases including
wet 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. KSI-501 is our dual inhibitor antibody
biopolymer conjugate targeting both VEGF (VEGF-trap) and IL-6
(anti-IL-6 antibody) for the treatment of retinal diseases. 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 of tarcocimab to be able to be given at longer intervals
to help patients and physicians realize the potential of anti-VEGF
therapy as a preventive treatment for NDPR; tarcocimab to relieve
the high treatment burden for NPDR patients; tarcocimab to provide
for prevention of vision loss among diabetic patients; timing of
primary results of the GLOW trial; tarcocimab tedromer to be a
first-line agent to improve outcomes for patients with retinal
vascular diseases and enable earlier treatment and prevention of
vision loss for patients with diabetic eye disease; the BEACON
pivotal study in patients with retinal vein occlusion, the DAYLIGHT
pivotal study in patients with wet AMD and the GLOW study in
patients with NPDR to form the anticipated basis of the Company's
BLA to support potential approval and commercialization in multiple
indications; tarcocimab tedromer to be the longest-interval
intravitreal therapeutic option for patients with diabetic
retinopathy and; including the results of the GLOW study in a
planned initial BLA submission for tarcocimab tedromer.
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
risk that tarcocimab may not be able to be given at longer
intervals; tacrocimab may not prevent vision loss among diabetic
patients; primary results of the GLOW trial may not be available in
a year; we may not develop a first-line agent to improve outcomes
for patients with retinal vascular diseases; the BEACON pivotal
study in patients with retinal vein occlusion, the DAYLIGHT pivotal
study in patients with wet AMD, and the GLOW study in patients with
NPDR may not form the basis of the Company's BLA to support
multiple indications; tarcocimab tedromer may not be the
longest-interval intravitreal therapeutic option for patients with
diabetic retinopathy; the results of the GLOW study may not be in a
planned initial BLA submission for tarcocimab tedromer; 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 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-K, 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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SOURCE Kodiak Sciences Inc.