SAN DIEGO, April 29, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced favorable
results from a Phase 1 single-ascending dose clinical trial of
APD371, a highly selective and potent agonist of the cannabinoid 2
(CB2) receptor currently in development for the treatment of pain
and potentially fibrotic diseases.
The randomized, double-blind and placebo-controlled Phase 1
clinical trial enrolled 56 healthy adults to evaluate the safety,
tolerability and pharmacokinetics of single-ascending doses of
APD371. Dose responsive exposure was observed over the explored
dose range of 10-400 mg with good tolerability at all doses
administered.
"In this trial, APD371 was well tolerated, as evidenced by the
lack of dose-limiting adverse events, at drug levels greatly
exceeding those anticipated as needed for activating the CB2
receptor," said William R. Shanahan,
Jr., M.D., Arena's Senior Vice President and Chief Medical
Officer. "We believe that the intrinsic properties of this compound
could offer advantages over currently marketed treatments for
pain."
About APD371
APD371, an orally available agonist of the CB2 receptor, is
Arena's internally discovered investigational drug candidate for
several potential indications, including pain and fibrotic
diseases. This compound, through its high level of observed
selectivity for the CB2 receptor versus the CB1 receptor, is
designed to provide pain relief without psychotropic effects or the
potential for dependence or abuse. Preclinical efficacy with APD371
has been shown in animal models of osteoarthritic and neuropathic
pain.
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 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, therapeutic indication, safety, efficacy and mechanism
of action of APD371; the potential of APD371, including as a
treatment for several potential indications, as compared to
currently marketed treatments, and in providing pain relief
without psychotropic effects or the potential for dependence or
abuse; the preliminary results of the Phase 1 clinical trial of
APD371, including their significance and support for advancing the
drug candidate; 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: the 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; APD371 may not
be further advanced, 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; 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 BELVIQ 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; 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
|
|
|
Scott A.
Rieger
|
David
Schull
|
Senior Director,
Investor Relations
|
President
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srieger@arenapharm.com
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david.schull@russopartnersllc.com
|
858.453.7200, ext.
1374
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858.717.2310
|
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SOURCE Arena Pharmaceuticals, Inc.