Clearside Biomedical Announces First Patients Enrolled in Phase 1/2a Clinical Trial of CLS-AX (axitinib injectable suspension...
January 12 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 that the first patients have been
enrolled in its Phase 1/2a clinical trial of CLS-AX (axitinib
injectable suspension) in patients with neovascular age-related
macular degeneration (wet AMD). Clinical sites, all based in the
United States, are activated and currently screening wet AMD
patients for this Phase 1/2a trial, known as OASIS, involving
CLS-AX, a proprietary suspension of axitinib for suprachoroidal
injection.
“The enrollment of the first patients for our
OASIS trial is a key milestone for Clearside as we execute our
strategy to expand our ophthalmology pipeline with innovative and
relevant opportunities targeting critical medical needs through the
suprachoroidal space (SCS®),” said George Lasezkay, Pharm.D., J.D.,
President and Chief Executive Officer. “We believe that axitinib, a
small molecule tyrosine kinase inhibitor (TKI), could provide
safety and efficacy comparable to, or better than, current standard
of care. And by delivering axitinib as a suspension into the
suprachoroidal space using our in-office, non-surgical SCS
Microinjector®, we may potentially extend the duration of
therapeutic action and reduce or relieve the profound treatment
burden for wet AMD patients. We expect data from our first cohort
of patients in mid-2021.”
OASIS is a Phase 1/2a open-label,
dose-escalation study in wet AMD patients to assess the safety and
tolerability of a single dose of CLS-AX administered by
suprachoroidal injection. 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 consists of 3 cohorts of 5
patients each (n=15). Cohort 1 participants will receive 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).
In preclinical studies, CLS-AX delivered
suprachoroidally was observed to be well tolerated and showed
significant ocular tissue concentrations over time. These
characteristics, if demonstrated clinically, may support the
potential for suprachoroidal axitinib to reduce or relieve the
treatment burden for patients suffering from wet AMD.
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 in a
Phase 1/2a clinical trial and additional information can be found
on https://clinicaltrials.gov (NCT04626128).
About Clearside’s Suprachoroidal Space
(SCS®) Injection
Platform
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.
Clearside’s unique platform is inherently flexible and intended to
work with certain established medications, new formulations of
small molecule medicines, as well as future innovations such as
gene therapy.
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. Clearside’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 such as gene
therapy. 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 development and
potential benefits of CLS-AX and the timing of data from the Phase
1/2a clinical trial for CLS-AX in wet AMD. 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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