SAN DIEGO, Dec. 8, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that it has
achieved its targeted enrollment goal of 372 participants in the
Phase 3 ELEVATE UC 52 trial evaluating the safety and efficacy of
once-daily etrasimod, a highly selective, once-daily, oral
sphingosine 1-phosphate (S1P) receptor modulator, in participants
with moderately-to-severely active ulcerative colitis.
"We are pleased that we have achieved our target enrollment and
maintained momentum, conduct, and timelines across the global
ELEVATE UC program. While we have achieved our enrollment goal for
the ELEVATE UC 52 trial, we have made the decision to extend
screening an additional three weeks based on the high number of
participants that we currently have in the screening queue. We
continue to expect topline data from both the ELEVATE UC 52 and UC
12 trials in Q1 2022. We remain highly focused on successful
clinical trial execution with careful attention to data integrity
and the safety of the trial participants," stated Sheldon Sloan, MD, Vice President and Global
Team Leader, Etrasimod, at Arena.
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. 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 over 400 sites across more than 40 countries.
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
Statements in this press
release that are not statements of historical fact are
forward-looking statements that involve a number of risks and
uncertainties. Such forward-looking statements may be identified by
words such as "on track," "potential," "may," "expect,"
"objective," "designed for," and "intended to," and 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 UC, its ability to satisfy an unmet
medical or clinical need, its potential effects, and its
selectivity, safety, and activity; our expectation regarding the
timing for topline data from the ELEVATE UC 12 and UC 52 trials;
screening for the ELEVATE UC 52 trial remaining open for an
additional three weeks; the significance of the ELEVATE UC 52 trial
and its enrollment; 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, 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 September 30, 2020,
which was 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.
Corporate Contacts:
Patrick Malloy
Arena Pharmaceuticals, Inc.
Vice President, Investor Relations & Corporate
Communications
pmalloy@arenapharm.com
847.987.4878
Megan E. Knight
Arena Pharmaceuticals, Inc.
Director, Investor Relations
mknight@arenapharm.com
858.210.3635
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SOURCE Arena Pharmaceuticals, Inc.