Clearside Biomedical Announces Completion of Dosing in Cohort 2 of Phase 1/2a Clinical Trial of CLS-AX (axitinib injectable suspension) in Wet AMD Patients
September 21 2021 - 7:05AM
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 completion of dosing in Cohort 2 of
OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib
injectable suspension) in patients with neovascular age-related
macular degeneration (wet AMD).
OASIS is a U.S.-based, multi-center, open-label,
dose-escalation trial in wet AMD patients to assess the safety and
tolerability of a single dose of CLS-AX administered by
suprachoroidal injection. All Cohort 2 patients have received
aflibercept at their first visit and a single dose of CLS-AX at
their second visit one month later. The primary endpoint for the
trial will assess the safety and tolerability of CLS-AX for three
months following the administration of CLS-AX.
“We are pleased to have completed our enrollment
and dosing of Cohort 2 patients after the promising safety and
tolerability results from Cohort 1,” said Thomas A. Ciulla, M.D.,
MBA, Chief Medical Officer and Chief Development Officer. “All
patients in Cohort 2 have now received both their aflibercept and
CLS-AX doses and will be monitored monthly by their physicians for
the next three months. We believe that by combining the pan-VEGF
attributes of axitinib with our proprietary CLS-AX formulation and
delivery via our SCS Microinjector®, we may facilitate an effective
treatment option for patients suffering from wet AMD. We expect to
report initial safety data from Cohort 2 by the end of this
year.”
About Neovascular Age-Related Macular
Degeneration (wet AMD)
Age-related macular degeneration causes a
progressive loss of central vision and is the most common cause of
legal blindness in individuals over age 55. Wet AMD is generally
caused by abnormal blood vessels that leak fluid or blood into the
macula, the part of the retina responsible for central vision, and
accounts for the majority of vision loss in patients with this
disorder. In the U.S., approximately 11 million patients are living
with AMD, and about 20% have the wet form. Current treatments
require life-long, frequent injections to maintain efficacy. This
treatment regimen tends to cause a treatment burden for patients
resulting in reduced compliance and under-treatment leading to
potentially limited outcomes.
About CLS-AX (axitinib injectable
suspension)
CLS-AX (axitinib injectable suspension) is a
proprietary suspension of axitinib for suprachoroidal injection.
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. Suprachoroidal injection of this
proprietary suspension of axitinib has demonstrated meaningful
potential in preclinical studies in multiple species. Preclinical
results from Clearside and independent investigators have shown
pharmacodynamic effects with reduced growth of experimental
neovascularization and decreased fluorescein leakage. With
suprachoroidal administration of axitinib, there is the potential
to achieve prolonged duration and targeted delivery to affected
tissue layers. Clearside is developing CLS-AX as a long-acting
therapy for the treatment of wet AMD.
About the OASIS Phase 1/2a Clinical
Trial
OASIS is an open-label, dose-escalation Phase
1/2a trial in wet AMD patients to assess the safety and
tolerability of a single dose 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 2 participants
received a dose of 0.1 mg of axitinib delivered via suprachoroidal
injection. Dose escalation will proceed following review of the
Cohort 2 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 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 safety data from 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.
Investor and Media Contacts:
Jenny Kobin Remy Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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