PALO ALTO, Calif., July 27, 2019 /PRNewswire/ -- Kodiak
Sciences Inc. (Nasdaq: KOD), a clinical stage biopharmaceutical
company specializing in novel therapeutics to treat chronic,
high-prevalence retinal diseases, today announced positive interim
results from the ongoing Phase 1b
study of KSI-301, its investigational intravitreal anti-VEGF
antibody biopolymer conjugate in patients with anti-VEGF
treatment-naïve neovascular (wet) age-related macular degeneration
(AMD), diabetic macular edema (DME), and macular edema due to
retinal vein occlusion (RVO).
The results were presented by Pravin U.
Dugel, M.D., an investigator in the study, as an oral
presentation at the American Society of Retina Specialists (ASRS)
2019 Annual Meeting. Dr. Dugel is Managing Partner, Retinal
Consultants of Arizona and Retinal
Research Institute, Phoenix, AZ,
and Clinical Professor, Roski Eye Institute, USC Keck School of Medicine, Los Angeles, CA. The detailed study findings
presented by Dr. Dugel can be found on the Kodiak Investor
Relations website at http://ir.kodiak.com.
Summary of Efficacy Outcomes through Week 12
Across all three diseases under study, strong improvements in
vision and retinal anatomy were observed over 12 weeks. Vision is
measured as change in Best Corrected Visual Acuity (BCVA) on a
standardized eye chart, and retinal anatomy is measured as change
in retinal central subfield thickness (CST) using optical coherence
tomography (OCT) imaging. The efficacy data presented at ASRS
include outcomes from 35 patients in the study who had reached the
week 12 visit. In the study, patients are being treated with three
monthly doses of either 2.5 mg or 5 mg KSI-301 and followed for 7
months thereafter, with additional treatments according to
protocol-specified retreatment criteria.
The following results were observed at Week 12*:
Disease (number
of patients)
|
Median
Baseline
BCVA, letters
|
Median Baseline
OCT CST,
microns
|
Change in Median
BCVA at Week 12,
letters
|
Change in Median
OCT CST at Week 12,
microns
|
Wet AMD
(n=17)
|
66
|
380
|
+8
|
-96
|
DME (n=8)
|
69.5
|
491
|
+9.5
|
-197
|
RVO (n=10)
|
52.5
|
513
|
+26.5
|
-209
|
*Includes patients who reached Week 12 visit by July 24, 2019 data cutoff date; 2.5 & 5 mg
doses pooled.
"We are pleased with KSI-301's promising efficacy and safety
data to date," said Jason Ehrlich,
M.D., Ph.D., Kodiak's Chief Medical Officer and Chief Development
Officer. "In addition to vision and anatomic improvements, we have
observed encouraging signs of disease modification. In the
individual case studies presented at ASRS, using OCT angiography we
observed normalization of retinal vascular flow in an RVO patient
seen as early as one week after the first dose and reduction in
choroidal neovascularization size and vascular flow rate in a wet
AMD patient. In a DME patient with proliferative retinopathy, we
observed conversion to non-proliferative retinopathy and a two-step
improvement in diabetic retinopathy severity score at the 12-week
assessment. These findings increase our conviction in the promise
of KSI-301 and the further potential of our ABC Platform. We look
forward to presenting emerging durability data from the Phase
1b study at the American Academy of
Ophthalmology Retina Subspecialty Day on October 11, 2019."
Summary of Safety Outcomes
A total of 200 injections with KSI-301 have been given to date
across the Phase 1a and Phase 1b
program with no intraocular inflammation or ocular serious adverse
events reported.
As of the July 24, 2019 ASRS
presentation's data cut-off date, a total of 77 patients were
enrolled in the Phase 1b study.
Multiple-dose exposure to KSI-301 has been well tolerated. A total
of 77 patients have received one injection, 60 patients have
received two injections and 44 patients have received three
injections. No drug-related adverse events or serious adverse
events have been reported. Most of the adverse events reported have
been assessed as mild (70%) and are consistent with the profile of
intravitreally-injected anti-VEGF agents. Eight non-ocular serious
adverse events have been reported in four patients, none being
assessed as drug-related.
Twelve leading retinal research centers in the United States are participating in the
Phase 1b study. For additional
details about the study, please see
https://clinicaltrials.gov/ct2/show/NCT03790852.
Phase 1b Trial
Expansion
The Phase 1b study of KSI-301 is
nearing completion of enrollment of the planned cohorts. Based on
the positive data observed to date, Kodiak is planning for
supplemental cohorts to explore additional scientific questions
relevant to KSI-301 and its use for the treatment of retinal
diseases.
Status of Phase 2 'DAZZLE' Study in Wet AMD
Recruitment in a Phase 2 head-to-head trial of KSI-301
versus aflibercept in treatment-naïve wet AMD patients is expected
to begin in the third quarter of 2019. In this study, called
DAZZLE, approximately 364 patients are planned to be enrolled
worldwide. Patients will be randomized to receive either KSI-301 on
a dosing regimen as infrequently as every 20 weeks or standard-care
aflibercept on its every 8-week dosing regimen. All patients
randomized to KSI-301 will be on an every 12-week or longer regimen
after three monthly loading doses.
About KSI-301
KSI-301 is an investigational therapy built on the Company's 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. KSI-301 is being developed and is
fully owned globally by Kodiak Sciences Inc.
About Kodiak Sciences Inc.
Kodiak™ is a clinical-stage biopharmaceutical company
specializing in novel therapeutics to treat chronic,
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 ABC Platform™ merges 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 as a
potential first-line agent for retinal vascular diseases including
age-related macular degeneration and diabetic eye diseases. 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 such as wet AMD and diabetic
retinopathy. Kodiak is based in Palo
Alto, CA. For more information, 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 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, including KSI-301, the
anticipated presentation of data, the results of our research and
development efforts, the anticipated presentation of additional
data 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," "ABC Platform" and the Kodiak logo are registered
trademarks or trademarks of Kodiak Sciences Inc. in various
jurisdictions.
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