Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, announced today positive safety results from Cohort 1 of
OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib
injectable suspension) administered by suprachoroidal injection via
Clearside’s SCS Microinjector® in six patients (n=6) with
neovascular age-related macular degeneration (wet AMD).
The primary endpoints were achieved in Cohort 1,
as the initial lowest planned dose of 0.03 mg CLS-AX was well
tolerated with no serious adverse events and no drug related
treatment emergent adverse events observed throughout the study
period. There were no signs of inflammation, no vasculitis, no
intraocular pressure (IOP) safety signals, no dispersion of drug
into the vitreous, or any other drug related adverse events
observed in any of the patients. The OASIS Safety Monitoring
Committee has reviewed the data and the trial will advance to
Cohort 2. Clearside expects to begin Cohort 2 patient screening for
a dose of 0.1 mg CLS-AX in June 2021 with completion of this four
month study period expected by the end of the year.
"We are very encouraged by the Cohort 1 results
of the OASIS trial and we are immediately beginning Cohort 2
enrollment as planned,” said Thomas A. Ciulla, M.D., MBA, Chief
Medical Officer and Chief Development Officer. “The initial data
from Cohort 1 clearly achieved our safety and tolerability
endpoints. While still early and recognizing there are a limited
number of patients, we believe the Cohort 1 data supports our
hypothesis that the combination of targeted and compartmentalized
suprachoroidal delivery and the potent pan-VEGF attributes of
axitinib may facilitate an effective treatment option for patients
suffering from wet AMD.”
The average age of the patients in Cohort 1 was
82 years and all were anti-VEGF treatment-experienced, having
undergone numerous injections of standard-of-care anti-VEGF
treatments prior to entering the OASIS trial. The mean number of
prior anti-VEGF treatments within the twelve months and up to the 3
years prior to the start of the trial was 9.0 injections and 22.5
injections, respectively. All enrolled patients underwent
diagnostic imaging at screening, followed by masked reading center
confirmation of persistent active disease. The mean central
subfield thickness (CST) of the macula was 231 µm (range 208 - 294
µm). The mean baseline best corrected visual acuity (BCVA) score as
measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
letters, at the start of the trial was 59.0 (range 29 - 74).
As part of the trial design, at the initial
visit, the six treatment-experienced patients in Cohort 1 received
a standard-of-care, single intravitreal injection of 2 mg
aflibercept. One month later, the mean ETDRS BCVA score
for all patients remained stable, changing only by -0.2 letters,
and patients then received a single suprachoroidal dose of 0.03 mg
CLS-AX. One month after receiving CLS-AX, five of six patients
exhibited improvement in BCVA, each gaining four or more letters,
with mean ETDRS BCVA score of all patients increasing by +4.7
letters (p=0.029, post hoc, unadjusted). In Cohort 1: no patients
required additional treatment with aflibercept at the one-month
visit post CLS-AX; two patients went three months post CLS-AX
without additional treatment with aflibercept and BCVA improved by
5 and 7 ETDRS letters for these patients; and four patients
received additional treatment with aflibercept at the two month
visit post CLS-AX. The mean CST was stable within 50 µm for all
Cohort 1 patients both at one month post 2 mg aflibercept and at
one month post 0.03 mg CLS-AX.
“CLS-AX was well-tolerated and these initial
results in this heavily treatment-experienced group of wet AMD
patients are promising. I look forward to the continued clinical
advancement of CLS-AX at the planned higher doses to further
explore potential benefits in visual acuity, ocular anatomy and
durability,” added Mark R. Barakat, M.D., Director of Research,
Retinal Consultants of Arizona; Clinical Assistant Professor,
University of Arizona College of Medicine, Phoenix.
The current OASIS trial protocol includes a
CLS-AX dose of 0.1 mg for Cohort 2 and 0.3 mg for Cohort 3, which
equates to 3.3x and 10.0x the Cohort 1 dose of 0.03 mg. The Company
expects to add a three-month extension study to follow patients in
Cohort 2 and Cohort 3. Combined data from the multiple cohorts of
the OASIS trial is planned to be presented at future medical
meetings.
Information on Clearside’s pipeline, including
the CLS-AX program and Cohort 1 top-line results, are included in
the Company’s corporate presentation which may be accessed on the
Clearside website under the Investors section: Events and
Presentations.
About the OASIS Phase 1/2a Clinical
Trial
OASIS is an open-label, single dose-escalation
Phase 1/2a trial in wet AMD patients to assess the safety and
tolerability of three increasing doses of CLS-AX administered by
suprachoroidal injection via Clearside’s SCS Microinjector®.
Eligible patients are those who demonstrate stable visual
acuity following two or more previous injections with an
intravitreal anti-VEGF agent. All enrolled patients undergo
diagnostic imaging on screening, followed by masked reading center
confirmation of persistent active disease.
Enrolled patients initially receive aflibercept
at the first visit followed by a single dose of CLS-AX at the
second visit one month later. The primary endpoint for the trial
will assess the safety and tolerability of CLS-AX for the three
months following the administration of CLS-AX, and secondary
endpoints will evaluate the pharmacokinetics, visual function,
ocular anatomy, and the need for additional treatment with
intravitreal aflibercept during the three-month period.
The study design is planned with 3 cohorts of
approximately 5 patients each (n=15). Cohort 1 participants
received the lowest dose, 0.03 mg of axitinib delivered via
suprachoroidal injection, and the trial is proceeding to Cohort 2
with a dose of 0.1 mg of axitinib. Dose escalation to the next
Cohort follows review of the safety data by the Safety Monitoring
Committee and their recommendation to advance to the next higher
dose cohort. Additional information on the Phase 1/2a trial can be
found on https://clinicaltrials.gov (NCT04626128).
About CLS-AX (axitinib injectable
suspension)
Axitinib is a tyrosine kinase inhibitor (TKI)
currently approved to treat renal cell cancer that achieves
pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3
with high potency and specificity. Clearside believes this broad
VEGF blockade may have efficacy advantages over existing retinal
therapies by acting at a different level of the angiogenesis
cascade and may benefit patients who sub-optimally respond to
current, more narrowly focused anti-VEGF therapies. Preclinical
studies by independent investigators have shown pharmacodynamic
effects with reduced growth of experimental neovascularization and
decreased fluorescein leakage.
CLS-AX (axitinib injectable suspension) is a
proprietary suspension of axitinib for suprachoroidal injection.
With suprachoroidal administration of axitinib, there is targeted
delivery of this pan-VEGF inhibitor to affected tissue layers for
potential efficacy benefits, as well as prolonged chorioretinal
tissue levels for potential durability benefits. Suprachoroidal
injection of this proprietary suspension of axitinib has
demonstrated meaningful potential in preclinical studies in
multiple species.
About Clearside’s Suprachoroidal Space
(SCS®) Injection Platform and SCS
Microinjector®
Clearside’s patented, proprietary suprachoroidal
space (SCS®) injection treatment approach offers unprecedented
access to the back of the eye where sight-threatening disease often
occurs. The company’s unique platform is inherently flexible and
intended to work with established and new formulations of
medications. Clearside’s proprietary SCS Microinjector® can be used
to inject a wide variety of drug candidates that are specifically
formulated to be delivered via suprachoroidal injection. The SCS
Microinjector provides targeted delivery to potentially improve
efficacy and compartmentalization of medication to reduce or
eliminate toxic effects on non-diseased cells. The SCS
Microinjector is composed of a syringe and two 30-gauge hollow
microneedles of varying lengths, each less than 1.2 millimeters,
within a custom-designed hub that optimizes insertion and
suprachoroidal administration of drugs.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector® targets the suprachoroidal space (SCS®) and offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications. For more information, please visit
www.clearsidebio.com.
Cautionary Note Regarding
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
Clearside’s current beliefs and expectations. These forward-looking
statements include statements regarding the clinical development,
including the timing of initiation of Cohort 2 patient screening
for the OASIS clinical trial, and the potential benefits of CLS-AX
and therapies using Clearside’s SCS Microinjector®. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Clearside’s reliance on third parties over
which it may not always have full control, uncertainties regarding
the COVID-19 pandemic and other risks and uncertainties that are
described in Clearside’s Annual Report on Form 10-K for the year
ended December 31, 2020, filed with the U.S. Securities and
Exchange Commission (SEC) on March 15, 2021, and Clearside’s other
Periodic Reports filed with the SEC. Any forward-looking statements
speak only as of the date of this press release and are based on
information available to Clearside as of the date of this release,
and Clearside assumes no obligation to, and does not intend to,
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Source: Clearside Biomedical, Inc.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
(678) 430-8206
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