SAN DIEGO, May 17, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that it has
initiated sites for its ELEVATE UC Phase 3 global program to
evaluate etrasimod 2 mg in subjects with moderately to severely
active ulcerative colitis (UC). Arena will present new data from
its investigative drug candidates etrasimod, a next-generation,
once-daily, oral, selective sphingosine 1 phosphate (S1P) receptor
modulator, and olorinab, a peripherally acting, highly
selective, full agonist of the cannabinoid type 2 receptor
(CB2) in development for the treatment of visceral pain
associated with gastrointestinal (GI) diseases, at Digestive
Disease Week® (DDW). DDW is the world's largest
gathering of physicians, researchers and industry in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. In addition to the presentations, Arena Pharmaceuticals
will have a booth at DDW located in the exhibit hall, booth
#3417.
"We are thrilled that we have initiated sites for our Phase 3
ELEVATE UC program. This further reinforces our commitment to
bringing a potential new therapy to inflammatory bowel disease
patients globally, and brings us one step closer to that goal,"
stated Preston Klassen, MD, MHS,
Executive Vice President, Research and Development and Chief
Medical Officer of Arena. "We hope to address the significant unmet
need that still affects 60-80% of IBD patients, who are either not
receiving or failing on current standard of care."
Etrasimod Presentations
Presentation Title: Histologic Remission and Mucosal
Healing in a Randomized, Placebo-Controlled, Phase 2 Study of
Etrasimod in Patients with Moderately to Severely Active Ulcerative
Colitis
Presenter: Laurent Peyrin-Biroulet, MD,
PhD
Session Date: May 21, 2019
Presentation Time: 10:45 AM - 11:00
AM
Location: Room 20BCD
Presentation Title: Correlation of Fecal Calprotectin
and C-Reactive Protein Concentrations with Clinical Outcomes and
Endoscopic Disease Activity in Patients with Ulcerative Colitis
Receiving Induction Therapy with Etrasimod
Presenter: Andres Yarur,
MD
Poster Session Date: May 21,
2019
Session Time: 12:00 PM –
2:00 PM
Poster Number: Tu1745
Location: Hall C-E
Olorinab Presentations
Presentation Title: Olorinab, a Peripherally Acting,
Highly Selective, Full Agonist of the Cannabinoid Type 2 Receptor
(CB2), Reduces Visceral Hypersensitivity in Animal
Models
Presenter: Stuart M.
Brierley, PhD
Poster Session Date: May 18,
2019
Session Time: 12:00 PM –
2:00 PM
Poster Number: Sa1738
Location: Halls C-E
Presentation Title: Safety and Efficacy of Olorinab, a
Peripherally Acting, Highly Selective, Cannabinoid Type 2 Receptor
Agonist in a Phase 2a Study in Chronic Abdominal Pain
Associated with Crohn's Disease
Presenter:
Bruce Yacyshyn, MD
Poster Session Date: May 19,
2019
SessionTime: 12:00 PM –
2:00 PM
Poster Number: Su1930
Location: Halls C-E
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 Olorinab
Olorinab (APD371) is an oral,
peripherally acting, highly selective, full agonist of cannabinoid
type 2 receptor (CB2) in development for the treatment
of visceral pain associated with gastrointestinal (GI) diseases,
including Crohn's disease and irritable bowel syndrome (IBS).
Evidence that CB2 are expressed in multiple cell types
of the GI tract, and modulate intestinal inflammation and visceral
hypersensitivity, make CB2 an attractive target for the
treatment of abdominal pain in GI disorders.
Olorinab 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 "will," "in development for,"
"potential," "goal," "hope to," "designed to," "driven to,"
"potentially," 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, olorinab and
Arena's other investigational drug candidates, including to be
first- or best-in-class or next-generation, have broad clinical
utility, or satisfy an unmet medical need; Arena's drive,
commitment, and goals; and the potential of Arena's assets,
programs, licenses, and collaborations. 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; 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; 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; our drug candidates may not advance in
development or be approved for marketing; unexpected or unfavorable
new data; risks related to developing and commercializing drugs;
risks related to relying on partners, licensees 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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SOURCE Arena Pharmaceuticals, Inc.