- Significant unmet need for new effective therapies exists
in ulcerative colitis
- ELEVATE UC clinical trial sites continue to
initiate
SAN DIEGO, June 17, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the first
subject has been dosed in ELEVATE UC 52, the first of two pivotal
trials within the Phase 3 ELEVATE UC registrational program
evaluating etrasimod 2 mg in subjects with moderately to severely
active ulcerative colitis (UC). ELEVATE UC 52 is a treat-through
trial with a 12-week induction period followed by 40 weeks of
maintenance. The ELEVATE UC registrational program aims to include
more than 40 countries worldwide.
"We are pleased to enroll the first patient in the ELEVATE UC
trial, supporting etrasimod's potential as an important future
therapy for ulcerative colitis," stated Darshan Anandu, MD,
Gastroenterology, G.I. Specialists of Houston. "With 60-80% of patients either not
receiving or failing on the current standard of care, there is a
clear and significant need for innovative options, especially
orally-delivered treatments."
"We are thrilled to announce the first patient dosed in the
ELEVATE UC 52 trial. The etrasimod data seen to date are highly
encouraging, and we believe represent a clear readthrough to our
ELEVATE UC pivotal program, providing us confidence that it will
demonstrate clinically meaningful and market-leading evidence of
efficacy and safety," stated Preston
Klassen, MD, MHS, Executive Vice President, Research and
Development and Chief Medical Officer of Arena. "Initiating this
trial is the next step towards bringing a potential game-changing
therapy to UC patients globally. We are very grateful to the
patients who have participated in etrasimod clinical trials thus
far, and to the many additional patients who will enroll in the
ELEVATE UC program. We also thank the physicians, medical
professionals, and site coordinators, for their continued
support."
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 subjects 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
primary 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 subjects at time points up
to 52 weeks of treatment. The ELEVATE UC program will be conducted
in approximately 450 sites across more than 40 countries.
About Etrasimod
Etrasimod (APD334), is a next
generation, oral, selective sphingosine 1 phosphate (S1P) receptor
modulator, discovered by Arena, designed to provide systemic and
local cell modulation by selectively targeting S1P receptor
subtypes 1, 4 and 5. Etrasimod has therapeutic potential in immune
and inflammatory-mediated diseases such as ulcerative colitis,
Crohn's disease, and atopic dermatitis. S1P receptors have been
demonstrated to be involved in the modulation of several biological
responses, including lymphocyte trafficking from lymph nodes to the
peripheral blood. By isolating subpopulations of lymphocytes in
lymph nodes, fewer immune cells are available in the circulating
blood to effect tissue damage.
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 and pharmacokinetics 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 and inflammatory conditions, is being evaluated in
later-stage clinical programs in ulcerative colitis (UC) and
Crohn's disease, as well as in programs for other indications such
as atopic dermatitis. 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 – preclinical), 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
accompanied by words such as "aims to," "potential," "future,"
"believe," "confidence that," "will," "step towards," "objective,"
"designed to," "driven to," "potentially," "being evaluated for,"
"evaluating for," "assess for," 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 to
be an important future therapy, be game-changing, or satisfy an
unmet medical need; the potential of prior etrasimod data,
including to represent a clear readthrough to the ELEVATE UC
pivotal program; the potential of the ELEVATE UC program,
including to demonstrate clinically meaningful and market-leading
evidence of etrasimod's efficacy and safety; Arena's drive; and the
potential of Arena's assets, programs, licenses, and
collaborations, 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; 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; enrolling patients
in our ongoing and intended clinical trials is competitive and
challenging; 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 (SEC), including but
not limited to its most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q. 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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