SAN DIEGO, Jan. 7, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced top-line
results from a Phase 1b multiple ascending dose clinical trial for
APD334, an oral drug candidate that targets the sphingosine
1-phosphate subtype 1 (S1P1) receptor for the potential
treatment of autoimmune diseases.
In the Phase 1b clinical trial, APD334 demonstrated a
dose-dependent effect on lymphocyte count lowering in blood, with
mean decreases from baseline of up to 69%. Lymphocyte counts, on
average, recovered to baseline within one week of conclusion of
dosing. There were no clinically significant safety findings with
respect to heart rate or rhythm or pulmonary function, and no
clinically significant elevations in liver enzyme tests. The most
common treatment-emergent adverse events were mild or moderate
contact dermatitis, headache, constipation and diarrhea, with none
being clearly drug related. There were no discontinuations for
adverse events, and no serious adverse events were observed.
"Lymphocyte lowering at the level demonstrated in this trial has
been shown to correlate with clinical efficacy in Phase 2 and Phase
3 trials of other S1P1 modulators in multiple sclerosis,
psoriasis and ulcerative colitis," said William R. Shanahan, M.D., Arena's Senior Vice
President and Chief Medical Officer. "The results of this trial
support investigation of the efficacy and safety of APD334 in
patients with autoimmune diseases."
The randomized, double-blind, placebo-controlled Phase 1b
clinical trial evaluated the safety, tolerability, pharmacodynamics
and pharmacokinetics of multiple-ascending doses of APD334. In five
different dosing cohorts, a total of 50 healthy volunteers received
APD334 and 10 received placebo for 21 days.
"Based on these impressive results, we plan to expedite APD334
into Phase 2 clinical trials for ulcerative colitis and Crohn's
disease," said Jack Lief, Arena's President and Chief Executive
Officer. "The advancement of this promising drug candidate further
demonstrates Arena's focused expertise in discovering and
developing innovative drug candidates targeting G protein-coupled
receptors that have the potential to improve health."
About Autoimmune Diseases
Autoimmune diseases, such as multiple sclerosis, psoriasis,
ulcerative colitis, Crohn's disease and rheumatoid arthritis, 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 tissue, 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 a potent and selective, orally available
investigational drug candidate that targets the S1P1
receptor. Discovered by Arena, APD334 has therapeutic potential in
autoimmune diseases. 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.
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, investigation, therapeutic indication, use, safety,
efficacy, mechanism of action, and potential of APD334, including
as a potential treatment for one or more autoimmune diseases; the
significance of the trial results for APD334, including with
respect to lymphocyte lowering and safety; the significance of
lymphocyte lowering and reducing the immune and/or inflammatory
response; expediting the development of APD334, including future
trials and investigated indications; Arena's expertise in
discovering and developing drug candidates that have the potential
to improve health; 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: top-line results are not comprehensive
and are based on a preliminary analysis of then available data, and
findings and conclusions related to the trial are subject to change
following a more comprehensive review of the data; 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; 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 and third parties' intellectual
property rights; 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.
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Media Contact: Russo
Partners
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Craig M. Audet,
Ph.D., Senior Vice President,
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David Schull,
President
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Operations & Head
of Global Regulatory Affairs
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david.schull@russopartnersllc.com
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caudet@arenapharm.com
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858.717.2310
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858.453.7200, ext.
1612
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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.