Clearside Biomedical Announces Completion of Patient Dosing in First Cohort of Phase 1/2a Clinical Trial of CLS-AX (axitinib ...
March 02 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 the first cohort
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. The first cohort of 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 made rapid progress
enrolling patients in our OASIS trial evaluating the use of
axitinib, a highly-potent small molecule tyrosine kinase inhibitor
(TKI), administered by suprachoroidal injection,” said Thomas A.
Ciulla, M.D., MBA, Chief Medical Officer and Chief Development
Officer. “This progress was made possible through the combined
efforts and commitment by patients, investigators, advisors and our
internal team. We believe that by combining the high potency and
pan-VEGF attributes of axitinib with our proprietary CLS-AX
formulation and delivery via our SCS Microinjector®, we may extend
the duration of therapeutic action and reduce or relieve the
profound treatment burden for wet AMD patients. We expect to report
initial safety data from this first cohort of patients in mid-2021
and continue on to a higher dose in the next cohort in the second
half of the year.”
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. CLS-AX is currently being
investigated in an ongoing U.S.-based, multi-center, open-label,
dose-escalation, Phase 1/2a, safety and tolerability study,
entitled OASIS, in wet AMD patients, and additional information can
be found on https://clinicaltrials.gov (NCT04626128).
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. 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. Dose escalation will then proceed
following 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 Clearside’s 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. 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, as well as future therapeutic innovations. 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, 2019,
filed with the U.S. Securities and Exchange Commission (“SEC”) on
March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020, filed with the SEC on November
10, 2020 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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