PALO ALTO, Calif., July 10, 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 promising
additional safety, efficacy and durability data from the ongoing
Phase 1b study of its investigational
therapy KSI-301, an intravitreal anti-VEGF antibody biopolymer
conjugate, in patients with treatment-naïve wet age-related macular
degeneration (wet AMD), diabetic macular edema (DME) and retinal
vein occlusion (RVO).
The data are presented online today at the American Society of
Retina Specialists 2020 Virtual Annual Meeting by Mark Barakat, M.D., an investigator in the study
and physician at Retina Consultants of Arizona, Phoenix,
AZ. The study findings presented by Dr. Barakat can be found
on the Kodiak Investor Relations website at http://ir.kodiak.com. A
livestreamed Q&A panel discussion will be held on Sunday, July 26, 2020, for ASRS Virtual Annual
Meeting attendees.
"Now supported by over 100 patient-years of clinical data in the
Phase 1b study and over 150
patient-years across the KSI-301 development program, we continue
to be very encouraged by the safety, efficacy, and durability of
KSI-301," said Jason Ehrlich, M.D.,
Ph.D., Chief Medical Officer of Kodiak Sciences. "In the data
presented today for Virtual ASRS, we observed that 82% of wet AMD
eyes and 76% of DME eyes treated with KSI-301 were extended to four
months or longer after the last loading dose before receiving their
first retreatment. 68% of wet AMD eyes have achieved a six-month
interval at least once during follow-up. In DME, with all patients
having now been followed for six months or longer after only three
initial loading doses (versus the five required with current
standard-of-care), it is remarkable that nearly half of patients
have yet to require any retreatment, and two-thirds of our DME
patients have gone six months or longer before receiving their
first retreatment."
"Importantly, KSI-301 is well-tolerated, and the safety profile
of KSI-301 remains excellent," continued Dr. Ehrlich. "With 546
doses given in the Phase 1a/1b
program, only two events of trace to 1+ intraocular inflammation
have occurred, the same two cases as reported previously. These
events resolved completely, and both patients have gained over five
eye chart lines of vision from their baseline (+30 and +27 letters,
respectively). The durability of KSI-301 is exceeding my
expectations. It is notable that we see very few retreatment
injections – in fact, only an average of 1.3 injections were given
in the wet AMD patients in the eight months after the loading
phase, and only 0.6 injections in DME patients and 1.3 in RVO
patients. This compares very favorably to the best current
standard-of-care anti-VEGF therapy (4.0, 5.0 and 8.0 injections,
respectively). We believe these results strongly support both the
disruptive KSI-301 dosing regimens in our pivotal study designs and
the studies' likelihoods of success."
"The latest Phase 1b study data,
where we see the durability of KSI-301 over longer periods of
treatment and follow-up, strongly reinforce the potential for
KSI-301 to be a foundational anti-VEGF therapy with a durability
profile that patients, physicians and payors are asking for," said
Victor Perlroth, M.D., Chief
Executive Officer of Kodiak Sciences. "We believe that a disruptive
'Generation 2.0' anti-VEGF therapeutic would allow nearly all wet
AMD and DME patients to be treated on a three-month or longer dose
interval and most RVO patients on a two-month or longer interval.
Our maturing Phase 1b study data
continue to surpass those goalposts. Indeed, for many wet AMD and
DME patients, our data suggest KSI-301 may be a once every five- or
six-month medicine."
"With all of our pivotal studies enrolling treatment-naïve
patients similar to those in our Phase 1b, we retain a high confidence in our KSI-301
development program," Dr. Perlroth continued. "Our DAZZLE study in
wet AMD, where KSI-301 is given as infrequently as every
five-months, continues to recruit well with over 340 patients
randomized to date in the US and Europe. We are very appreciative of the
support from the ophthalmology community. We look forward to
initiating pivotal studies in DME, RVO, and potentially diabetic
retinopathy later this year, as we continue advancing KSI-301 on
track for our 2022 Vision of a BLA filing in these key indications.
We will be discussing these clinical plans in more detail at our
July 27, 2020, R&D webinar on the
heels of the livestreamed Virtual ASRS panel."
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. In
December 2019, Kodiak entered into an
agreement to sell a 4.5% capped royalty right on global net sales
of KSI-301 to Baker Bros. Advisors for $225
million.
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 our
belief that KSI-301 may achieve disruptive dosing regimens; the
likelihood of success of our KSI-301 Clinical Program; the
potential for KSI-301 to be a foundational anti-VEGF therapy with a
durability profile that patients, physicians and payors will seek;
our ability to initiate pivotal studies in DME, RVX and potentially
diabetic retrinopathy in 2020; our ability to achieve our 2022
Vision, including a single BLA submission in wet AMD, DME, RVO and
diabetic retinopathy in 2022; our platform technology and potential
therapies; future development plans; 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 anticipated
presentation of data; 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," "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; 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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