SAN DIEGO, March 8, 2019 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) presented new Phase 2 data
from its investigative drug candidates etrasimod, a
next-generation, oral, selective sphingosine 1 phosphate (S1P)
receptor modulator in development for the treatment of moderate to
severely active ulcerative colitis (UC), and olorinab, a
peripherally restricted, highly selective, full agonist of the
cannabinoid receptor type 2 (CB2) in development for the
treatment of visceral pain associated with gastrointestinal (GI)
diseases, at the 14th Congress of European Crohn's and
Colitis Organisation (ECCO).
"The new data presented from the Phase 2 trial of etrasimod
demonstrate that both mucosal healing and histological remission
were seen in patients with moderate to severe ulcerative colitis
following just 12 weeks of treatment," said Laurent
Peyrin-Biroulet, MD PhD, Professor of Medicine and Head of the
Inflammatory Bowel Disease Unit, Inserm, University Hospital of
Nancy, France. "These results
continue to support etrasimod's potential as an important future
therapy and we look forward to further validating these data in the
soon to be initiated ELEVATE Phase 3 clinical program for etrasimod
in UC."
Etrasimod Presentation Details - Awarded "Top-10
Oral Poster 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
"Non-opioid-based treatments for visceral pain associated with
Crohn's disease address an area of significant unmet need,
especially in patients in whom nonsteroidals and opioids are
restricted," stated Peter Doyle
Higgins MD, PhD, Professor, Director of Inflammatory Bowel
Disease Program, Director of Ambulatory and Chronic Disease
Clinical Trials Support Unit, University of
Michigan. "These data from the olorinab program highlight
its potential as a novel approach for the management of GI pain
that may lack abuse potential. I look forward to further clinical
studies of this promising candidate therapy in Crohn's disease and
IBS with the hopes of providing a new treatment option to patients
in need of relief from chronic abdominal pain."
Olorinab Presentation Details
Title: Safety and Efficacy of Olorinab, a
Peripherally Restricted, Highly-Selective, Cannabinoid Receptor 2
Agonist in a Phase 2a Study in Chronic Abdominal Pain Associated
with Crohn's Disease
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 restricted, highly selective, full agonist of
cannabinoid receptor type 2 (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's licensee, United Therapeutics, is evaluating ralinepag in a
Phase 3 program for pulmonary arterial hypertension (PAH).
Arena has additional license agreements and partnerships,
including with 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 "potential," "future," "look forward
to," "soon to be," "may," "promising," "hopes of," "designed to,"
"in development for," "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, have broad
clinical utility, lack abuse potential, or satisfy an unmet medical
need; Arena's drive; 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 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 our Annual Report on Form 10-K for the year ended
December 31, 2018, which was filed
with the SEC on February 28, 2019.
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.