SAN DIEGO, Sept. 1, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the first
subject has been dosed in a Phase 2 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 alopecia areata. The randomized,
placebo-controlled trial will evaluate the efficacy and safety of
etrasimod 2 mg for 24 weeks in 36 subjects in sites across
the United States and Canada.
"It is exciting to see the clinical advancement of an oral agent
with a novel mechanism of action for the potential treatment of
alopecia areata," stated Brett King,
MD, PhD, Associate Professor of Dermatology, Yale School of Medicine. "With no currently
FDA-approved treatment options there is a significant unmet medical
need in alopecia areata. I see patients suffer tremendous emotional
and psychosocial distress and reduced quality of life as a result
of this disease. I look forward to seeing the progress of Arena's
Phase 2 program and the development of etrasimod."
"Dosing the first patient in our Phase 2 alopecia areata trial
is a great accomplishment for the team, furthering our expansion
into dermatology," stated Chris
Cabell, MD, MHS, FACC, Executive Vice President, Head of
Research and Development, and Chief Medical Officer at Arena. "To
date, we have seen preclinical and scientific validation supporting
the rationale for moving etrasimod into alopecia areata and other
dermatologic conditions. Etrasimod has demonstrated the potential
to reduce circulating CD4+ and CD8+ T-lymphocytes. In alopecia
areata, this may reduce the T cells available to infiltrate the
hair follicle, which may decrease inflammation and restore hair
growth. We expect the availability of Phase 2 data in 2021."
This Phase 2 multicenter, randomized, placebo-controlled trial
will assess the safety and efficacy of once-daily etrasimod 2 mg in
subjects with moderate-to-severe alopecia areata. The primary
endpoint is percent change in Severity of Alopecia Tool (SALT)
score from baseline to week 24. The trial will enroll 36 subjects
and will be conducted in study sites across the United States and Canada.
About Alopecia Areata
Alopecia areata, or AA, is a
T-cell-mediated autoimmune skin disorder with unmet medical need
that causes non-scarring patchy hair loss, most often on the scalp.
Mild disease typically presents as one or more round or oval bald
patches on the scalp. In moderate-to-severe disease, extensive and
chronic hair loss occurs, with the most severe forms involving hair
loss on the entire scalp (alopecia totalis) or body (alopecia
universalis). Patients with persistent moderate-to-severe AA also
often suffer emotional and psychosocial distress and reduced
quality of life as a result of their hair loss.
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, atopic dermatitis and alopecia areata.
Etrasimod is an investigational compound that is not approved
for any use in any country.
About Arena Pharmaceuticals
ARENA
Pharmaceuticals is a team with a singular purpose – deliver
our important medicines to patients.
In a rapidly changing global market, we work with a sense of
urgency every day to understand the needs of all our stakeholders,
identify bold, sometimes disruptive, ideas to get our medicines to
patients, and relentlessly execute until it's done.
ARENA - Care More. Act Differently.
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. Such forward-looking statements may be
identified by words such as "evaluating," "potential," "will,"
"look forward to," "expect," and "may," and include, without
limitation, statements about the following: the opportunity,
development and potential of etrasimod, including regarding its
design, its safety and efficacy, its therapeutic potential in
immune-mediated inflammatory diseases such as ulcerative colitis,
Crohn's disease, atopic dermatitis, and alopecia areata, and its
ability to reduce patients' distress, improve lives, and satisfy an
unmet medical or clinical need; the Phase 2 trial, including
enrollment, study sites, trial design, and timing of Phase 2 data;
the significance of the trial and its initiation; and Arena's
purpose, work, understanding, ideas, and execution. 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, but are not limited to, the following: clinical
trials and other studies may not proceed at the time or in the
manner expected, or at all; the timing and outcome of research,
development and regulatory review is uncertain, and Arena's drug
candidates may not advance in development or be approved for
marketing; enrolling patients in Arena's ongoing and intended
clinical trials is competitive and challenging; the duration and
severity of the coronavirus disease (COVID-19) pandemic, including
but not limited to its impact on Arena's clinical trials and
operations, the operations of Arena's suppliers, partners,
collaborators, licensees, and the capital markets, which in each
case remains uncertain; risks related to developing and
commercializing drugs; Arena may need additional funds to advance
all of its programs; risks and uncertainties relating to cash and
revenues that may be generated from product sales or other sources,
including the impact of competition; risks related to unexpected or
unfavorable new data; nonclinical and clinical data is 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; results of clinical trials and other studies are
subject to different interpretations and may not be predictive of
future results; topline data may not accurately reflect the
complete results of a particular study or trial; satisfactory
resolution of litigation or other disagreements with others;
government and third-party payor actions, including relating to
reimbursement and pricing; risks related to relying on licenses or
collaborative arrangements, including lack of control and potential
disputes; the entry into or modification or termination of licenses
or collaborative arrangements; and Arena's and third parties'
intellectual property rights. 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 (SEC), including but
not limited to Arena's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020, which
was filed with the SEC on August 5,
2020. 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:
Megan E. Knight
Arena Pharmaceuticals, Inc.
Director, Investor Relations
mknight@arenapharm.com
858.210.3635
Arena Media Contact:
IR@arenapharm.com
858.453.7200
View original content to download
multimedia:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-announces-first-subject-dosed-in-phase-2-trial-evaluating-etrasimod-in-alopecia-areata-301121386.html
SOURCE Arena Pharmaceuticals, Inc.