- ADVISE clinical trial initiated and enrollment progressing
- Evaluating patients with the clinical diagnosis of
moderate-to-severe atopic dermatitis
- Significant unmet need for an oral therapy in atopic
dermatitis
SAN DIEGO, Oct. 28, 2019 /CNW/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the first
subject has been dosed in the Phase 2 ADVISE trial evaluating
etrasimod, an investigational next-generation, once-daily, oral,
selective sphingosine 1-phosphate (S1P) receptor modulator, for the
potential treatment of moderate-to-severe atopic dermatitis (AD).
The trial will evaluate the efficacy and safety of two doses of
etrasimod for 12-weeks in approximately 120 subjects in sites
across the United States,
Canada and Australia.
"I am pleased that Arena is currently enrolling patients in its
Phase 2 ADVISE study, advancing an oral agent with a novel
mechanism of action for the potential treatment of atopic
dermatitis," said Jonathan I.
Silverberg, MD, PhD, MPH, Associate Professor of
Dermatology, Director of Clinical Research, and Director of Patch
Testing, at the George Washington University
School of Medicine and Health Sciences. "Moderate-to-severe
atopic dermatitis remains a disease with significant unmet medical
needs. Patients and their families experience great
burden on their quality of life and overall health, with negative
impacts on physical and emotional well-being, social functioning,
and activities of daily living."
"The decision to move into dermatology, and specifically atopic
dermatitis, is founded on scientific, preclinical and early
clinical supporting evidence," stated Preston Klassen, MD, MHS, Executive Vice
President, Head of Research and Development at Arena. "We are
confident that etrasimod has the potential to be a first-in-class
oral therapy in atopic dermatitis, and we look forward to seeing
the Phase 2 data in the second half of 2020."
About ADVISE
ADVISE is a Phase 2 multicenter,
randomized, double-blinded, placebo-controlled study (with an
open-label extension) to assess the safety and efficacy of
once-daily etrasimod in subjects with moderate-to-severe atopic
dermatitis. The primary endpoint is percent change in Eczema Area
and Severity Index (EASI) from baseline to week 12, followed
by a 4-week follow-up observation period. The ADVISE trial will
enroll approximately 120 subjects and will be conducted in
study sites across the United
States, Canada and
Australia.
About Atopic Dermatitis
Atopic dermatitis (AD) is a
serious, chronic immune-mediated disease in which symptoms vary,
but often include severe dry skin, itching, patches, swollen skin
and raised bumps which may leak fluid.
About Etrasimod
Etrasimod (APD334) is a next
generation, once-daily, oral, highly selective sphingosine
1-phosphate (S1P) receptor modulator discovered by Arena, and
designed for optimized pharmacology and engagement of S1P receptor
1, 4 and 5 which may lead to an improved efficacy and safety
profile.
Etrasimod provides systemic and local effects on specific immune
cell types and has the potential to treat multiple immune-mediated
inflammatory diseases including ulcerative colitis, Crohn's
disease, and atopic dermatitis.
Etrasimod is an investigational compound that is not approved
for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is driven to deliver novel,
transformational medicines with optimized pharmacology to patients
globally. Arena's proprietary pipeline includes multiple
potentially first- or best-in-class assets with broad clinical
utility. Etrasimod (APD334), with potential utility in a broad
range of immune-mediated inflammatory diseases, is being evaluated
in later-stage clinical programs in inflammatory bowel disease
(IBD), a Phase 2 program in atopic dermatitis (AD), as well as
progressing programs for other potential indications. Arena is also
evaluating olorinab (APD371) in a Phase 2 program for
gastrointestinal pain. Arena continues to assess other earlier
research and development stage drug candidates, including APD418
for decompensated heart failure.
Arena has additional license agreements and partnerships,
including with United Therapeutics (ralinepag in a Phase 3 program
for pulmonary arterial hypertension), Everest Medicines Limited
(etrasimod in Greater China and
select Asian countries), Boehringer Ingelheim International GmbH
(undisclosed target – preclinical), Outpost Medicine, LLC
(undisclosed target – Phase 1), and Eisai Co., Ltd. and Eisai Inc.
(BELVIQ® – marketed product).
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. These forward-looking statements may be
identified by introductory words such as "evaluating",
"progressing," "will," "advancing," "potential," "initiating,"
"confident that" "look forward to," "designed to," "driven to,"
"potentially," "being evaluated for," "assess," or words of similar
meaning, or they may be identified by the fact that they do not
relate strictly to historical or current facts. Such
forward-looking statements include, without limitation, statements
about the following: the opportunity, development and potential of
etrasimod, including regarding its design, its therapeutic
potential in immune-mediated inflammatory diseases such as
ulcerative colitis, Crohn's disease, and atopic dermatitis, its
ability to treat atopic dermatitis, improve lives, and
satisfy an unmet medical or clinical need, and its safety and
efficacy; the ADVISE trial, including enrollment, study sites,
trial design, and timing of Phase 2 data; the significance of the
ADVISE trial and its initiation; Arena's drive; and the potential
of Arena's assets, programs, licenses, and partnerships, including
to be first- or best-in-class or have broad clinical utility. For
such statements, Arena claims the protection of the Private
Securities Litigation Reform Act of 1995. Actual events or results
may differ materially from Arena's expectations. Factors that could
cause actual results to differ materially from the forward-looking
statements include: the timing and outcome of research, development
and regulatory review is uncertain; enrolling subjects in our
ongoing and intended clinical trials is competitive and
challenging; results of clinical trials and other studies are
subject to different interpretations and may not be predictive of
future results; nonclinical and clinical data are voluminous and
detailed, and regulatory agencies may interpret or weigh the
importance of data differently and reach different conclusions than
Arena or others, request additional information, have additional
recommendations or change their guidance or requirements before or
after approval; clinical trials and other studies may not proceed
at the time or in the manner expected or at all; we expect to need
additional funds to advance all of our programs, and you and others
may not agree with the manner we allocate our resources; our drug
candidates may not advance in development or be approved for
marketing; risks related to unexpected or unfavorable new data;
risks related to developing and commercializing drugs; risks
related to relying on partners and other third parties; Arena's and
third parties' intellectual property rights; and satisfactory
resolution of litigation or other disagreements with others.
Additional factors that could cause actual results to differ
materially from those stated or implied by Arena's forward-looking
statements are disclosed in Arena's filings with the Securities and
Exchange Commission. These forward-looking statements represent
Arena's judgment as of the time of this release. Arena disclaims
any intent or obligation to update these forward-looking
statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, MD
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.