- Primary endpoint and all key secondary endpoints met with high
statistical significance in GLOW study.
- With 6-month dosing of all patients, tarcocimab and the ABC
platform continue to demonstrate differentiated durability.
- Following dialogue with US regulatory authorities, Kodiak plans
to conduct one additional pivotal study with a commercial
formulation of tarcocimab.
- New regulatory strategy could support a single Biologics
License Application (BLA) for macular edema following retinal vein
occlusion (RVO), wet age-related macular degeneration (wAMD) and
non-proliferative diabetic retinopathy (NPDR).
- Kodiak believes that it has sufficient capital to fund a
comprehensive KSI-501 clinical program in parallel.
PALO
ALTO, Calif., Nov. 6, 2023
/PRNewswire/ -- Kodiak Sciences Inc. (NASDAQ: KOD) today
announced that its Phase 3 GLOW superiority study evaluating
tarcocimab tedromer 5 mg in moderately severe to severe NPDR met
its one-year primary endpoint.
"This is the first time that 6-month dosing in all patients
succeeded in treating diabetic retinopathy which we believe is a
meaningful and clinically relevant achievement", said Dr. J.
Pablo Velazquez-Martin, Senior Vice
President of Clinical Sciences at Kodiak Sciences. "We think that
the consistency of the data across all endpoints, where tarcocimab
significantly improved the diabetic eye disease status and,
importantly, significantly prevented sight-threatening
complications, is remarkable," continued, Dr. Velazquez-Martin.
"The GLOW data reinforce the durability potential of tarcocimab and
the antibody biopolymer conjugate platform (ABC Platform) in the
management of retinal vascular diseases."
"We think that durability remains the most clinically relevant
unmet patient need," said Dr. Victor
Perlroth, CEO of Kodiak. "We now have three successful phase
3 pivotal studies with tarcocimab tedromer across three different
retinal vascular and exudative diseases: wet AMD, RVO and NPDR. In
recent discussions with the FDA, which included the GLOW data, we
believe we have a clear regulatory pathway requiring one additional
positive study to support a single BLA submission for all three
indications," continued Dr. Perlroth.
"We have actionable learnings from the tarcocimab clinical
program that we used to develop an enhanced commercial formulation
of tarcocimab that balances free antibody and conjugated antibody
to improve manufacturability and, importantly, to improve usability
by reducing injection time from 7-10 seconds to 2-3 seconds. This
formulation has already been manufactured at commercial scale and
is ready for use in clinical trials. After evaluation of the Phase
3 data across the tarcocimab program and based on conversations
with members of the retina community, we believe our commercial
tarcocimab formulation could be an important future therapeutic
option. As a result, we have decided to run another pivotal study
with the intent to file a single BLA for RVO, wet AMD and NPDR.
This enhancement to the ABC Platform is also being implemented in
our first-in-class anti-IL-6 and anti-VEGF bispecific, KSI-501
ABC," Dr. Perlroth concluded.
Kodiak paused further development of tarcocimab last summer
after its GLEAM and GLIMMER studies in diabetic macular edema did
not meet their primary endpoint, in order to evaluate learnings
from its pivotal BEACON study in patients with macular edema due to
retinal vein occlusion and from its GLOW study.
The company believes that the one-year head-to-head BEACON
results and primary endpoint and key secondary endpoint GLOW
results support the development of three attractive clinical
prospects: enhanced tarcocimab ABC, enhanced bispecific
KSI-501 ABC, and our KSI-501 bispecific free protein (not
conjugated) and that Kodiak has on hand sufficient capital to
further develop in parallel all three of these prospects.
Dr. Perlroth added, "Kodiak thanks the GLOW investigators and
patients whose participation and commitment helped us to generate
strong data in GLOW and thus to recognize the continued importance
for patients of our ABC Platform and our platform-derived
medicines."
About the GLOW Study Results
First time results from GLOW were presented at the American
Academy of Ophthalmology retina subspecialty day on November 3, 2023. View original content:
https://ir.kodiak.com/static-files/ee94e5bd-da6e-4038-b00c-1956c72e5c72.
The Phase 3 GLOW study investigated an every 24-week tarcocimab
dosing regimen for all subjects, versus sham, in patients with
moderately-severe and severe NPDR without DME.
At one year, GLOW met its primary endpoint of the proportion of
patients with at least a 2-step improvement on the Diabetic
Retinopathy Severity Scale (DRSS) score, a grading system measuring
the degree of retinopathy. Tarcocimab achieved a 29-fold increased
response rate ratio, with 41.1% of evaluable patients on tarcocimab
demonstrating at least 2-step improvement versus 1.4% of evaluable
patients in the sham group (p less than 0.0001). Visual acuity and
retinal anatomy were improved and stable with tarcocimab on its
extended-dosing intervals.
GLOW also met all key secondary endpoints, including greater
reductions in the proportion of patients developing
sight-threatening complications (such as diabetic macular edema and
proliferative diabetic retinopathy), versus sham, demonstrating an
89% decreased risk, achieving 21.0% versus 2.3% (p less than
0.0001). Tarcocimab also showed a 95% risk reduction in the
development of DME, versus sham, from 13.7% on sham versus 0.7% on
tarcocimab.
After the occurrence of a sight-threatening complication, all
subjects were rescued with open-label tarcocimab, where subjects
received two loading doses once monthly followed by continued every
12-week dosing. In patients developing sight-threatening
complications, the initial visual acuity decrease and retinal
anatomy worsening were both rapidly controlled and then stabilized
with every 12-week dosing of tarcocimab.
The rates of serious ocular adverse events and intraocular
inflammation in patients treated with tarcocimab and sham were
similar in both groups.
About the GLOW Study Design
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 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 the Primary Endpoint of ≥2-Step Improvement on the
Diabetic Retinopathy Severity Scale (DRSS)
Derived from The Early Treatment Diabetic Retinopathy Study
(ETDRS), the diabetic retinopathy severity scale (DRSS) is a
systematic grading system developed to predict the risk of
progression from NPDR to proliferative diabetic retinopathy (PDR).
The DRSS characterizes retinopathy based on assessment of
abnormalities in seven defined fields of fundus photographs.
The scale divides diabetic retinopathy into levels ranging from
absent to severe proliferative diabetic retinopathy. This scale is
the most widely used standard for grading degrees of retinopathy in
clinical studies.
About the Key Secondary Endpoint of Reducing Sight
Threatening Complications
Approximately eight million people in the U.S. live with
Diabetic Retinopathy (DR), a common complication of diabetes
characterized by damage to the blood vessels in the retina.
Diabetic retinopathy occurs when blood vessels in the retina are
damaged by chronic high blood sugar levels caused by diabetes. DR
is the leading cause of blindness among working-age American
adults. The disease generally starts as NPDR and often has no
warning signs or symptoms. Over time, patients with NPDR are at
risk of suffering sight-threatening complications, including
diabetic macular edema (DME), a swelling of the macula (the part of
the retina responsible for central fine vision) and proliferative
diabetic retinopathy (PDR) in which abnormal blood vessels grow on
the surface of the retina and into the vitreous cavity.
Sight-threatening complications can lead to severe vision loss in
patients.
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.
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:
Kodiak's plans to resume development of tarcocimab tedromer,
conduct an additional pivotal study and potentially submit a single
BLA for wAMD, RVO and NPDR; the pathway for a single potential BLA
submission for approval of tarcocimab for RVO, wAMD and NPDR on the
basis of the BEACON, DAYLIGHT and GLOW plus one additional pivotal
trial; the sufficiency of Kodiak's capital to fund tarcocimab and
other clinical programs; tarcocimab and the ABC Platform's
differentiated durability profile; the potential for Kodiak's ABC
Platform and tarcocimab to be important innovations for patients;
the expected enhancements and benefits of a new formulation of
tarcocimab, KSI-501 or other ABC Platform derived molecules; and
expectations and plans for the development of KSI-501.
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 the BEACON and/or GLOW results may not
provide the evidence, insights or benefits as anticipated; the risk
that the results of the tarcocimab Phase 3 studies plus one
additional pivotal study may not be sufficient to support a single
BLA submission for wAMD, RVO and NPDR; the risk that a BLA may not
be accepted by, or receive approval from, the FDA or foreign
regulatory agencies when expected, or at all; the risk that a new
formulation of tarcocimab, KSI-501 or other ABC Platform derived
molecules may not provide the benefits expected; the risk that
cessation, modification or delay of any of the ongoing clinical
studies and our development of tarcocimab and/or KSI-501 may occur;
the risk that safety, efficacy and durability data observed in our
product candidates in current or prior studies may not continue or
persist; the risk that our ABC Platform or tarcocimab may not
represent important innovations for patients; the risk that our
research and development efforts and our ability to advance our
product candidates into later stages of development may fail; the
risk that KSI-501 may not inhibit VEGF and IL-6 or have an impact
on the treatment of patients as expected; the risk that 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, 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; the risk that sufficient capital may not be
available as expected, or at all, to complete the development of
any products; 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®, 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.