SAN DIEGO, Oct. 29, 2015 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation
of patient dosing in a Phase 1b multiple-ascending dose clinical
trial of APD371, a selective and potent agonist of the cannabinoid
2 (CB2) receptor.
This randomized, double-blind, placebo-controlled Phase 1b
clinical trial will enroll approximately 36 healthy adults to
evaluate the safety, tolerability and pharmacokinetics of
multiple-ascending doses of APD371. In a previous single-ascending
dose trial, APD371 demonstrated dose responsive exposure over the
explored range of 10-400 mg with good tolerability at all
doses.
"As with all of our other clinical-stage compounds, APD371 was
internally discovered by Arena's scientists," said Harry F. Hixson, Jr., Arena's interim Chief
Executive Officer. "This is another demonstration of Arena's
expertise in discovering and developing differentiated drug
candidates to address unmet medical needs."
About APD371
APD371, an orally available agonist of the CB2 receptor, is an
internally discovered investigational drug candidate that Arena is
exploring for potential development in several indications,
including pain. This compound, through its selectivity, is
designed to provide pain relief without psychotropic effects and
without the potential for dependence or abuse. Preclinical efficacy
with APD371 has been shown in several animal models of pain.
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 has US operations
located in San Diego, California, and operations outside of the
United States, including its
commercial manufacturing facility, 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 protocol, design, scope, enrollment and
other aspects of the Phase 1b clinical trial of APD371; exploring
APD371 for potential development in several indications; the
potential of APD371, including in providing pain relief
without psychotropic effects or the potential for dependence or
abuse; discovering and developing differentiated drug candidates to
address unmet medical needs; 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: APD371 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.
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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SOURCE Arena Pharmaceuticals, Inc.