SAN DIEGO, June 3, 2014 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation
of dosing in an investigational Phase 1b clinical trial of APD334,
a novel, oral drug candidate that targets the sphingosine
1-phosphate subtype 1 (S1P1) receptor, to evaluate the
compound for the treatment of a number of autoimmune diseases.
This randomized, double-blind and placebo-controlled Phase 1b
trial will evaluate the safety, tolerability and pharmacokinetics
of multiple-ascending doses of APD334 in up to 96 healthy adult
volunteers.
"We continue to make progress in advancing our novel pipeline of
internally discovered drug candidates, and remain committed to our
vision of leading the industry in the discovery, development and
commercialization of GPCR-directed medicines," said William R. Shanahan, M.D., Arena's Senior Vice
President and Chief Medical Officer.
About Autoimmune Diseases
Autoimmune diseases are characterized by an inappropriate immune
response against substances and tissues that are normally present
in the body. In an autoimmune reaction, a person's antibodies and
immune cells target healthy tissues, triggering an inflammatory
response. Reducing the immune and/or inflammatory response is an
important goal in the treatment of autoimmune diseases.
About APD334
APD334 is an orally available investigational drug candidate
discovered by Arena that targets the S1P1 receptor, with
therapeutic potential in a spectrum of autoimmune diseases, such as
multiple sclerosis, psoriasis and rheumatoid arthritis.
S1P1 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 lymphocytes in lymph nodes, fewer immune cells are
available in the circulating blood to effect tissue damage. Arena
has optimized APD334 as a potent and selective small molecule
S1P1 receptor agonist that reduces the severity of
disease in preclinical autoimmune disease models.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena's internally discovered drug, BELVIQ®
(lorcaserin HCl), is approved in the
United States, and Arena is focused on discovering,
developing and commercializing additional drugs to address unmet
medical needs. Arena's US operations are located in San Diego, California, and its operations
outside of the United States,
including its commercial manufacturing facility, are located in
Zofingen, Switzerland. For more
information, visit Arena's website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are registered service marks
of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of
Arena Pharmaceuticals GmbH.
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 include statements about the
advancement, therapeutic indication, use, safety, efficacy,
mechanism of action and potential of APD334; the protocol, design,
scope, enrollment, expectations and other aspects of the Phase 1b
trial of APD334; progress in advancing Arena's pipeline; embracing
the challenge of improving health; seeking to bring innovative
medicines to patients; and Arena's commitment, vision, focus,
plans, goals, strategy, expectations, research and development
programs, and ability to discover and develop compounds and
commercialize drugs. 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: risks related to commercializing drugs,
including regulatory, manufacturing, supply and marketing issues
and the availability and use of BELVIQ; cash and revenues generated
from BELVIQ, including the impact of competition; Arena's revenues
will be based in part on estimates, judgment and accounting
policies, and incorrect estimates or disagreement regarding
estimates or accounting policies may result in changes to Arena's
guidance or previously reported results; the timing and outcome of
regulatory review is uncertain, and BELVIQ may not be approved for
marketing when expected or ever in combination with another drug,
for another indication or using a different formulation or in any
other territory for any indication; regulatory decisions in one
territory may impact other regulatory decisions and Arena's
business prospects; government and commercial reimbursement and
pricing decisions; risks related to relying on collaborative
arrangements; the timing and receipt of payments and fees, if any,
from collaborators; the entry into or modification or termination
of collaborative arrangements; 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;
data and other information related to any of Arena's research and
development may not meet regulatory requirements or otherwise be
sufficient for (or Arena or a collaborator may not pursue) further
research and development, regulatory review or approval or
continued marketing; Arena's ability to obtain and defend patents;
the timing, success and cost of Arena's research and development;
results of clinical trials and other studies are subject to
different interpretations and may not be predictive of future
results; clinical trials and other studies may not proceed at the
time or in the manner expected or at all; having adequate funds;
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. 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.
Contact: Arena
Pharmaceuticals, Inc.
|
|
|
Media Contact: Russo
Partners
|
|
|
|
|
Craig Audet, Senior
Vice President,
|
|
|
David Schull,
President
|
Operations and Head
of Global Regulatory Affairs
|
|
|
david.schull@russopartnersllc.com
|
caudet@arenapharm.com
|
|
|
858.717.2310
|
858.453.7200, ext.
1612
|
|
|
|
|
|
|
|
www.arenapharm.com
|
|
|
|
SOURCE Arena Pharmaceuticals, Inc.