PALO
ALTO, Calif., Nov. 1, 2023
/PRNewswire/ -- Kodiak Sciences Inc (NASDAQ: KOD) today
announced that data from tarcocimab tedromer will be presented
during the annual meeting of the American Academy of Ophthalmology
(AAO) to be held November 3-6 in
San Francisco.
During the Retina Subspecialty Day on November 3, detailed results will be presented
for the first time from the Phase 3 GLOW study of tarcocimab
tedromer in patients with non-proliferative diabetic
retinopathy.
In the pivotal GLOW study, all patients are randomized to
receive either tarcocimab 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 was the proportion of
tarcocimab-treated patients who experienced at least a 2-step
improvement on the diabetic retinopathy severity scale (DRSS), a
grading system measuring the degree of retinopathy, as compared to
patients in the sham group. The Key Secondary Endpoint was the
proportion of tarcocimab treated patients who suffered a sight
threatening complication including progression to diabetic macular
edema or proliferative diabetic retinopathy, as compared to
patients in the sham group.
Diabetic retinopathy (DR) is a common complication of diabetes
that affects the eye. If left untreated, diabetic retinopathy
progresses and eventually can lead to serious vision-threatening
complications, such as diabetic macular edema and
proliferative diabetic retinopathy. It is estimated that of the 36
million American adults living with diabetes, 10 million have
diabetic retinopathy.
"We are pleased to have topline results from the GLOW study
ready to be presented at the AAO Retina Subspecialty Day," said Dr.
Pablo Velazquez-Martin, Senior Vice
President of Kodiak Sciences. "This dataset is the last of the six
pivotal Phase 3 studies we have run with tarcocimab. Long interval
dosing is particularly important in the diabetic retinopathy
population, and the GLOW study explores the ability of tarcocimab,
with all patients on an every 6-month dosing interval, to directly
improve the disease (the primary endpoint) and to prevent vision
threatening complications from the worsening of the disease (key
secondary endpoint). In GLOW, there are no loading doses. Instead,
tarcocimab is given in a progressive extended dosing regimen with
all patients treated on a 6-month interval before the end of year
1. This translates to only 4 doses in the first year of
treatment."
Presentation Details:
Friday, November 3rd (Retina
Subspecialty Day)
Section IX: First-time Results in Clinical Trials
Outcomes From the Randomized, Controlled Phase 3 GLOW Trial:
Management of Diabetic Retinopathy with KSI-301 (tarcocimab
tedromer)
Presenting author: Charles C. Wykoff, MD, PhD
Oral presentation at 4:56 p.m.
PDT.; Moscone Convention Center, room West 3004
The presentation material is expected to be posted under the
Investor Relations section of the Kodiak corporate website
concurrently with the start of the oral presentation and can be
found at https://ir.kodiak.com/events-and-presentations/events.
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 treatment-naïve patients with
moderately severe to severe non-proliferative diabetic retinopathy
("NPDR"). Patients are randomized to receive either tarcocimab
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. Outcomes include changes in
diabetic retinopathy severity, measured on a standardized
photographic grading scale, and the proportion of tarcocimab
treated patients who developed a sight threatening complication 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. 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 antibody biopolymer conjugate
platform, or ABC Platform™ is at the core of Kodiak's discovery
engine. Kodiak's first investigational medicine, tarcocimab
tedromer, is a novel anti-VEGF antibody biopolymer conjugate
explored for the treatment of retinal vascular diseases. Kodiak's
second clinical program, KSI-501, built from a first-in-class
bispecific protein targeting both IL-6 (anti-IL-6 antibody) and
VEGF (VEGF-trap), is intended to treat both orphan and high
prevalence retinal diseases. Kodiak is based in Palo Alto,
CA. For more information, please
visit www.kodiak.com.
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.