PALO ALTO, Calif., July 16, 2020 /PRNewswire/ -- Kodiak
Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical
company specializing in novel therapeutics to treat chronic,
high-prevalence retinal diseases, today announced that it will host
a R&D Webcast for investors and analysts on Monday, July 27 at 1:30
p.m. Pacific Time (4:30 p.m. Eastern
Time).
At the R&D webcast, Kodiak senior management will discuss
recent safety, efficacy, and durability data from the ongoing Phase
1b study of KSI-301 in wet
age-related macular degeneration (wet AMD), diabetic macular edema
(DME), and retinal vein occlusion (RVO). Management will also
highlight continuing progress with the pivotal study of KSI-301 in
treatment-naïve wet AMD patients (DAZZLE) and review planned
pivotal studies in DME, RVO and non-proliferative diabetic
retinopathy (NPDR).
A live webcast of will be available on the "Events and
Presentations" section of Kodiak's website at
http://ir.kodiak.com/ and will remain available for replay for
a limited time following the event.
Investors, equity research analysts and others interested in
participating in the Q&A portion of the event may contact
ir@kodiak.com.
About KSI-301
KSI-301 is an investigational anti-VEGF therapy built on the
Company's Antibody Biopolymer Conjugate, or 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. The Company's DAZZLE pivotal study in patients with
treatment-naïve wet AMD was initiated in October 2019. Kodiak plans to initiate additional
pivotal studies of KSI-301 in 2020 in diabetic macular edema,
retinal vein occlusion and diabetic retinopathy. These studies are
anticipated to form the basis of the Company's initial BLA to
support potential approval and commercialization. KSI-301 is being
developed and is fully owned globally by Kodiak Sciences Inc.
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 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 the KSI-301 Clinical Program
The KSI-301 Clinical Program is designed to assess KSI-301's
safety, efficacy and durability in wet AMD, DME, RVO and
non-proliferative DR (without DME) through clinical studies run in
parallel. We have agreed on the order and number of clinical
studies required to support the licensure of KSI-301 in wet AMD,
DME, RVO and non-proliferative DR at an end of phase 2 meeting with
the U.S. Food and Drug Administration (FDA). We confirmed that two
clinical studies conducted in a single indication are expected by
FDA to demonstrate the initial safety and efficacy of KSI-301. One
clinical study each in the additional disease indications, if
successful, can be used to support approval in the additional
indications. We intend to conduct two Phase 3 studies in DME (the
GLEAM and GLIMMER studies) to provide the mutually confirmatory
studies required by FDA for initial demonstration of safety and
efficacy. We also intend to conduct one study in wAMD (our ongoing
DAZZLE study) and one study in RVO (the BEACON study) to support
approval of these additional indications. We intend to file this
package together in a single BLA in 2022. We also plan to run an
additional study in patients with non-proliferative DR without DME
(the GLOW study) which depending on data readiness may be combined
either into the single initial BLA or may be filed as a
supplemental BLA. We expect that the global KSI-301 clinical
program will be conducted at 100+ study sites in more than 10
countries.
About Kodiak Sciences Inc.
Kodiak (Nasdaq: KOD) is a clinical stage biopharmaceutical
company developing novel therapeutics to treat chronic,
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, a leading cause of blindness in elderly
patients, and diabetic retinopathy, a leading cause of blindness in
working-age patients. 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
future development plans and the potential licensure of KSI-301;
our platform technology and potential therapies; 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; 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," "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 may 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®, 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.