SAN DIEGO, July 29, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation
of patient screening in a Phase 2 proof-of-concept clinical trial
of APD334 in ulcerative colitis. Discovered by Arena, APD334 is an
oral, investigational, Sphingosine 1-Phosphate Subtype 1
(S1P1) receptor modulator with therapeutic potential in
ulcerative colitis as well as other autoimmune diseases.
"Important goals of pharmacotherapy for ulcerative colitis are
to induce and maintain remission while improving the patient's
quality of life, and, based on the results from our Phase 1
program, we believe APD334 has the potential to achieve these
goals," said Jack Lief, Arena's President and Chief Executive
Officer. "In addition to ulcerative colitis, we believe APD334
could have utility for a variety of autoimmune diseases."
This 12-week, three-arm, double-blind, placebo-controlled Phase
2 trial will enroll approximately 240 patients with moderate to
severe ulcerative colitis. The primary endpoint of the trial is
clinical remission. Continuation of treatment to 52 weeks will be
offered to participants in a separate long-term extension
study.
Arena previously completed a Phase 1 program for APD334 that
demonstrated a dose-dependent effect on lymphocyte count lowering
in blood. A multiple-ascending dose, Phase 1 clinical trial showed
mean decreases from baseline in lymphocyte counts up to 69% and
recovery on average to baseline within one week of drug
discontinuation. There was a modest impact on heart rate, but none
of the changes were classified by the investigator as clinically
significant. There were also no findings with respect to pulmonary
function or liver enzyme tests that were classified by the
investigator as clinically significant.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease that affects the large
intestine. The innermost lining of the large intestine becomes
inflamed and ulcers may form on the surface, which can cause
symptoms such as frequent bowel movements, diarrhea and bloody
stools. The inflammation is usually found in the rectum and can
include all or a portion of the colon. Currently available
treatment options have limitations in terms of side effects,
patient response, efficacy and administration. Arena believes that
an effective, orally available S1P1 receptor modulator
that provides clinical benefits without current limitations has the
potential to improve treatment for patients with ulcerative
colitis.
About APD334
APD334 is a potent and selective, orally available
investigational drug candidate that targets the S1P1
receptor. Discovered by Arena, APD334 has therapeutic potential in
autoimmune diseases such as ulcerative colitis. 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
subpopulations of lymphocytes in lymph nodes, fewer immune cells
are available in the circulating blood to effect tissue damage.
About Arena Pharmaceuticals
Arena embraces the challenge of improving health by seeking to
bring innovative medicines targeting G protein-coupled receptors to
patients. Arena's focus is discovering, developing and
commercializing drugs to address unmet medical needs, and
BELVIQ® (lorcaserin HCl) is Arena's first internally
discovered drug approved for marketing. 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, investigation, therapeutic indication, use, safety,
efficacy, mechanism of action, significance and potential of
APD334, including relative to other therapies; the protocol,
design, scope, enrollment, expectations and other aspects of the
Phase 2 trial of APD334; the importance of goals related to
pharmacotherapy for ulcerative colitis and the potential of APD334
with respect to such goals; APD334's utility for a variety of
autoimmune diseases; the potential of an effective, orally
available S1P1 receptor modulator; embracing the
challenge of improving health; seeking to bring innovative
medicines to patients; and Arena's 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: APD334
may not be developed, approved for marketing or commercialized for
any disease or condition; risks related to commercializing drugs,
including regulatory, manufacturing, supply and marketing issues
and the availability and use of BELVIQ or lorcaserin; cash and
revenues generated from BELVIQ, including the impact of
competition; the risk that Arena's revenues are 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 lorcaserin may not be approved for marketing 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 and
third parties' intellectual property rights; the timing, success
and cost of Arena's research and development and related strategy
and decisions; 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.
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Media Contact: Russo
Partners
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Craig M. Audet,
Ph.D., Senior Vice
President,
Operations & Head
of Global Regulatory
Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
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David Schull,
President
david.schull@russopartnersllc.com
858.717.2310
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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.