– Evaluating 2 mg etrasimod in study
participants with moderately-to-severely active ulcerative colitis
(UC)
– Topline data from ELEVATE UC 12 and UC 52
trials remain on track for Q1 2022
– Significant unmet need for safe and effective
oral therapies in UC for patients with inadequate response, loss of
response or intolerance to conventional or advanced therapies
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that
it has completed full enrollment of the Phase 3 ELEVATE UC 52 trial
evaluating the safety and efficacy of etrasimod, a highly
selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor
modulator, in participants with moderately-to-severely active
ulcerative colitis. The trial enrolled 433 study participants in
approximately 40 countries globally.
“Completion of UC 52 enrollment is the first important step in a
comprehensive clinical program designed to potentially provide
broad access and improve outcomes in patients with
moderately-to-severely active ulcerative colitis. We thank our
investigators, clinical site coordinators and especially the
participants in the trial for enabling us to meet this important
milestone,” said Paul Streck, M.D., Senior Vice President, Clinical
Development and Chief Medical Officer at Arena. “We expect topline
data from both the ELEVATE UC 52 and UC 12 trials in Q1 2022, and
we remain focused on successful clinical trial execution with
careful attention to data integrity and the safety of the trial
participants.”
About ELEVATE UC 52
ELEVATE UC 52 is one of two pivotal trials that are part of the
ELEVATE UC global Phase 3 registrational program. ELEVATE UC 52 is
a 2:1 randomized, double-blind, placebo-controlled trial to assess
the efficacy and safety of etrasimod 2 mg once-daily in
participants with moderately-to-severely active ulcerative colitis
(UC) defined as a baseline 3-domain, modified Mayo Score of 4 to 9
with an endoscopic score of 2 or more, and a rectal bleeding score
of 1 or more. This is a one-year trial evaluating clinical
remission at 12 weeks, or induction, and at 52 weeks. The trial
consists of a 28-day screening period, a 12-week treatment period,
a 40-week treatment period, and a 2-week follow-up period. The
primary objective of this trial is to assess the safety and
efficacy of etrasimod on clinical remission after both 12 and 52
weeks. The primary endpoint is the FDA-required, 3-domain, modified
Mayo Score, which is similar to the endpoint in the Phase 2 OASIS
study of etrasimod in UC. Key secondary measures include the
efficacy of etrasimod on clinical response, symptomatic response
and remission, endoscopic changes, corticosteroid-free remission,
and a total healing in these participants at time points up to 52
weeks of treatment. The ELEVATE UC program is being conducted in
approximately 40 countries globally.
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 is intended to provide 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, eosinophilic esophagitis, 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
“designed to,” “expect,” “may,” “lead to,” and “potentially,” and
include, without limitation, statements about the potential
benefits of the ELEVATE UC 52 trial, the timing of topline data
from both the ELEVATE UC 52 and UC 12 trials, the potential
benefits of etrasimod, 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; the duration and severity
of the COVID-19 pandemic, including but not limited to its impact
on Arena’s clinical trials and operations and the operations of
Arena’s suppliers, partners, collaborators, and licensees, which in
each case remains uncertain; risks related to developing and
commercializing drugs; 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; 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 under the heading “Risk Factors” in
Arena’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2020, filed with the SEC on November 9, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210202005438/en/
Corporate Contact: Patrick Malloy Arena Pharmaceuticals,
Inc. Vice President, Investor Relations & Corporate
Communications pmalloy@arenapharm.com 847.987.4878
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